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T he e f f e ct o n s ub j e ct i v e q ua l i t y o f l i f e o f o c cup a t i o na l t h e ra p y b a s e d o n a d j us t i ng t h e cha l l e ng e - s ki l l b a l a n ce :
a ra nd o m i z e d co nt ro l l e d t ri a l
I p p e i Y o s hi d a
1 , 2Ka z u ki H i ra o
3R y u j i Ko b a y a s hi
1* 1 De p a rt m e nt o f O cc up a t i o na l T h e ra p y , G ra d ua t e S c ho o l o f H um a n H e a l t h S c i e n ce s , T o ky o Me t ro p o l i t a n U ni v e r s i t y
* 2 De p a rt m e nt o f R e ha b i l i t a t i o n, H a rue H o s p i t a l
* 3 De p a rt m e nt o f O cc up a t i o na l T h e ra p y , G ra d ua t e S c ho o l o f H e a l t h S ci e nce s , K i b i I nt e rna t i o na l U n i v e r s i t y
C l i ni ca l re ha b i l i t a t i o n , 3 3 ( 1 1 ) , 1 7 3 2 - 1 7 4 6 . 2 0 1 9 A rt i cl e f i rs t p ub l i s h e d o nl i ne : J ul y 4 , 2 0 1 9 ; I s s ue p ub l i s he d : N o v e m b e r 1 , 2 0 1 9
R e ce i v e d : N o v e m b e r 2 8 , 2 0 1 8 ; A c ce p t e d : Ma y 2 9 , 2 0 1 9
T hi s p a p e r ha s b e e n p ro ce s s e d a s p a rt o f a d o ct o ra l
d i s s e rt a t i o n t h ro ug h t he c re d i t o f S A GE p ub l i ca t i o n .
DOI : 1 0 .1 1 7 7 /0 2 6 9 2 1 5 5 1 9 8 5 8 7 1 3
I nt ro d u ct i o n
C l i e nt - ce nt e re d p ra ct i ce s a i m e d a t e na b l i ng cl i e nt s t o p a rt i ci p a t e i n s p e ci f i c a ct i v i t i e s t ha t a re i m p o rt a nt t o t he m a r e co n s i d e re d i m p o rt a nt e l e m e nt s i n re ha b i l i t a t i o n . S e v e ra l
b e ne f i t s , s uc h a s i n cre a s e d m o t i v a t i o n a s we l l a s t h e
e f f e ct i v e n e s s o f r e ha b i l i t a t i o n, ha v e b e e n r e p o rt e d u s i ng s uc h p ra ct i c e s [ 1 , 2 ] . I t s s uc ce s s i s d e p e n d e nt o n t he a b i l i t y o f re ha b i l i t a t i o n t he ra p i s t s t o i n co rp o ra t e cl i e nt s ’ d e s i re s t o t h e re ha b i l i t a t i o n p ro c e s s . H o we v e r , n u m e ro u s re ha b i l i t a t i o n t he ra p i s t s f o c us o n t he i r e x p e ri e n ce s a nd v a l ue s o r
m i s u nd e r s t a nd t he cl i e nt ’ s d e s i re s , t he re b y t e nd i ng t o e x cl ud e cl i e nt s f ro m t he d e ci s i o n - m a k i ng p r o ce s s [ 2 - 4 ] . M o re o v e r , t he re e x i s t un e q ua l r e l a t i o ns hi p s b e t w e e n t he ra p i s t s a nd c l i e nt s o wi ng t o d i f f e re nc e s i n e x p e rt i s e re g a rd i ng i l l ne s s a nd
d i s a b i l i t y [ 5 ] . R e p o rt e d l y , s u ch re l a t i o ns hi p s m a y re s ul t i n t he cl i e nt e x p e ri e n ci ng ne g a t i v e e m o t i o ns , s u ch a s a l a ck o f s e l f - e s t e e m , a nd a d v e r s e l y a f f e ct t he re ha b i l i t a t i o n p ro ce s s [ 6 , 7 ] .
R e ha b i l i t a t i o n t he ra p i s t s a t t e m p t t o i ncl ud e t he c l i e nt s i n g o a l s e t t i ng p ro ce s s u s i ng t he C a na d i a n O cc up a t i o na l
P e rf o rm a n ce Me a s u re [ 8 ] a nd Go a l A t t a i nm e nt S ca l i ng [ 9 ] ;
m o re o v e r, t h e y e v a l ua t e co m p re he n s i v e l i f e f un ct i o ns u s i ng t he I nt e rna t i o na l C l a s s i f i ca t i o n o f F un c t i o ni ng Di s a b i l i t y a nd
H e a l t h [ 1 0 ] . H o we v e r, t h e re i s o f t e n i n s u f f i ci e nt co n f i rm a t i o n re g a rd i ng t he s u i t a b i l i t y o f v a r i o u s a p p ro a che s t o a c hi e v e t he s e g o a l s f o r t h e cl i e nt . A g o o d g o a l i s t y p i ca l l y co ns i d e re d t o b e s p e ci f i c , m e a s u ra b l e , a ch i e v a b l e , re a l i s t i c/ re l e v a nt , a nd t i m e b o und ( S MA R T ) [ 1 1 ] ; ho we v e r, co n s t a nt l y v e ri f y i ng t he
s ui t a b i l i t y o f t he g o a l s o r a p p ro a ch e s i n cre m e nt a l l y o f f e re d i n re s p o ns e t o c ha ng e s i n cl i e nt ’ s a b i l i t y i s c ha l l e ng i ng .
C o ns i d e ri ng t he s e p r o b l e m s , we d e s i g ne d a r e ha b i l i t a t i o n p ro ce s s t ha t a p p l i e s f l o w t he o ry [ 1 2 ] t o s ha re t he v a ri o u s
f a ct o r s o f re ha b i l i t a t i o n p ro ce s s , i n cl ud i ng g o a l s e t t i ng , w i t h cl i e nt s a s we l l a s t o p r o m o t e t a s k s whi ch he l p cl i e nt s
m a i nt a i n i ng p o s i t i v e m e nt a l a t t i t ud e . F l o w ( a l s o t e rm e d “ z o ne ” ) i s d e f i n e d a s “ a s t a t e i n w hi c h p e o p l e a re s o i nv o l v e d i n a n
a ct i v i t y t ha t no t h i ng e l s e s e e m s t o m a t t e r; t he e x p e r i e n ce i s s o e nj o y a b l e t ha t p e o p l e wi l l co nt i n ue t o d o i t e v e n a t g r e a t c o s t , f o r t he s he e r s a ke o f d o i ng i t ” [ 1 2 ] . P re v i o us s t ud i e s ha v e
d e m o ns t ra t e d t ha t t he f l o w s t a t e co nt ri b ut e s t o ha p p i n e s s , s e l f -
e s t e e m , a nd q ua l i t y o f l i f e [ 1 3 – 1 5 ] . One o f t he f a ct o r s l e a d i ng
t o t he f l o w s t a t e i s t h e cha l l e ng e – s ki l l b a l a nc e f o r a n a ct i v i t y , a nd co ns i d e r i ng t hi s , t h e re l a t i o n s h i p b e t we e n f l o w s t a t e a nd o t he r n e g a t i v e e m o t i o ns i s m o d e l e d a s a f l o w m o d e l [ 1 2 ] . I n t hi s m o d e l , f l o w i s e x p e ct e d t o o c cu r wh e n t he c ha l l e ng e - s k i l l
b a l a nce f o r a a ct i v i t y i s a ch i e v e d . O n t he o t he r ha nd , a nx i e t y i s e x p e ri e nc e d w he n t he cha l l e ng e e x c e e d s t he s k i l l a nd b o r e d o m i s e x p e ri e n ce d whe n t he s ki l l e x ce e d s t he c ha l l e ng e . T h e re f o re , i n o u r re s e a r ch , b a s e d o n t hi s f l o w m o d e l , we ha v e d e s i g n e d a n a p p ro a ch t e rm e d “ a d ju st ing t h e cha lleng e – s kil l b a la nce” t o b a l a nce t h e cha l l e ng e s a nd s k i l l s i n t he re ha b i l i t a t i o n p r o ce s s a nd v e r i f y i t s e f f e ct .
I n o ur p re v i o u s re s e a r ch , we co nd u c t e d o c cup a t i o na l t he ra p y wi t h a d j ust ing t he c ha ll eng e – sk ill b a la n ce in o ld er a d ul t s us i ng a n a d ul t d a y p r o g ra m a nd e x a m i ne d t he e f f e ct s o f t hi s a p p ro a c h o n t he h e a l t h - re l a t e d q ua l i t y o f l i f e [ 1 6 ] . B e ca u s e o nl y o n e a ct i v i t y wa s t a rg e t e d a nd t he num b e r o f i nt e rv e nt i o ns wa s 1 0 , t he a p p ro a c h o f a d j us t i ng t he t a s k wa s s ho rt - t e rm a nd we we re una b l e t o v e ri f y m u l t i p l e a ct i v i t i e s i n t h e
re ha b i l i t a t i o n p ro c e s s . T h e re f o re , w e t a rg e t e d c l i e nt s
und e rg o i ng re c o v e ry r e ha b i l i t a t i o n a nd d e c i d e d t o re p e a t t he
a p p ro a ch o f a d ju st ing t h e cha l le ng e – ski ll b a la n ce for m u lt ip le a ct i v i t i e s . F urt he rm o re , we d e v e l o p e d a p r o ce s s s up p o rt t o o l us i ng i nf o rm a t i o n t e rm i na l s t o e n s u re t he co ns i s t e ncy a nd co nt i n ui t y o f t he a p p r o a c h a m o ng t he t he ra p i s t s . B a s e d o n a p ro t o co l d e s i g n e d v i a p re l i m i na ry r e s e a r ch [ 1 7 , 1 8 ] , t he p re s e nt s t ud y a i m e d t o e x a m i n e t he e f f e ct o f a d d i ng t he a d ju st i ng t he cha l leng e – s kil l b a la nce t o t he r eha b ilit a t io n p roc ess o n t he s ub j e ct i v e q ua l i t y o f l i f e a s w e l l a s o n t he co s t - e f f e ct i v e ne s s , i f a ny , v i a a ra nd o m i z e d c o nt r o l l e d t r i a l .
M e t ho d s D e s i g n
T he p ro t o co l ha s b e e n p ub l i s h e d i n a p e e r - re v i e we d j o u rna l [ 1 8 ] . T hi s s t ud y co m m e nc e d i n Oct o b e r 2 0 1 7 , a nd t he f o l l o w - up e v a l ua t i o n wa s co m p l e t e d i n Oct o b e r 2 0 1 8 . T he s t ud y wa s co nd u ct e d a c co rd i ng t o t he s t a n d a rd s o f D e c l a ra t i o n o f H e l s i n ki a nd wa s a p p ro v e d b y t h e E t hi c s R e v i e w C o m m i t t e e o f t he T o ky o Me t ro p o l i t a n U ni v e rs i t y ( N o . 1 7 0 2 0 ) a nd wa s
re g i s t e re d i n t h e t ri a l r e g i s t r y ( U M I N 0 0 0 0 2 9 5 0 5 ) . A l l cl i e nt s
p ro v i d e d wr i t t e n i n f o rm e d c o n s e nt .
I n t h i s ra nd o m i z e d co nt ro l l e d t ri a l , we co m p a re d t he a p p ro a che s o f a d j ust ing t he c ha ll en g e – sk ill b a la n ce wit h o cc up a t i o na l t he ra p y ( e x p e ri m e nt a l g ro up ) a nd co nv e nt i o na l o cc up a t i o na l t he ra p y ( c o nt r o l g ro up ) b a s e d o n t he C o ns o l i d a t e d S t a nd a rd s o f R e p o rt i ng T r i a l s c ri t e r i a [ 1 9 ] . Out co m e s w e re m e a s ur e d a t a d m i s s i o n t o t he re co v e ry re ha b i l i t a t i o n u ni t ( “ p re ” a s s e s s m e nt ) , a t d i s c ha rg e ( “ p o s t ” a s s e s s m e nt ) , a nd a t 3 - m o nt hs a f t e r d i s c ha rg e ( “ f o l l o w - up ” a s s e s s m e nt ) . T h e p r i m a ry o ut co m e wa s c ha ng e i n s ub j e ct i v e q ua l i t y o f l i f e , a nd t he
s e co nd a ry o ut co m e s we r e cha ng e s i n he a l t h - re l a t e d q ua l i t y o f l i f e , f l o w e x p e ri e nc e , a nd a ct i v i t i e s o f d a i l y l i v i ng , a s we l l a s t he co s t - e f f e ct i v e ne s s .
C l i e nt s we r e re c ru i t e d a t t he r e co v e ry re ha b i l i t a t i o n u ni t o f H a rue H o s p i t a l , F uk ui , J a p a n . C l i e nt s a g e d < 5 0 y e a rs o r
> 1 0 0 y e a r s o n a d m i s s i o n t o t he u ni t we re e x c l ud e d f ro m t he t ri a l . T hi s cr i t e ri o n i s b a s e d o n a n a g e ra ng e s e t t o ± 2
s t a nd a rd d e v i a t i o n s o f 7 5 .7 ± 1 2 .3 y e a rs , wh i c h wa s t he m e a n a g e o f p re v i o u s l y a d m i t t e d c l i e nt s . T he cl i e nt s we re b l i nd e d t o t he a s s i g nm e nt ; ho we v e r, t he p r i n ci p a l i nv e s t i g a t o r,
i nt e rv e nt i o n t he ra p i s t s , a nd e v a l ua t o rs we re no t b l i nd e d .
B e ca us e t he p ro c e d ur e s p e rf o rm e d i n t he e x p e ri m e nt a l g ro up we re co n s i d e re d f e a s i b l e i n a ny re h a b i l i t a t i o n p r o ce s s e s
re g a rd l e s s o f t he d i s e a s e , we i ncl ud e d p a t i e nt s wi t h
ce re b ro s p i na l a nd m u s c ul o s ke l e t a l d i s e a s e s , w hi ch a re t h e m a i n t a rg e t d i s e a s e s o f t he re co v e ry re ha b i l i t a t i o n un i t . Mo re o v e r , t he p r e s e nt s t u d y re q ui re s co m m un i ca t i o n a nd co m p re h e n s i o n s ki l l s t o i m p l e m e nt cl i e nt - ce nt e re d re ha b i l i t a t i o n p ro c e s s e s i n b o t h g ro up s , a nd t he o ut co m e s a d o p t e d t he cl i e nt ’ s s e l f -
re p o rt e d q ue s t i o nna i re . T he re f o re , we e x cl ud e d cl i e nt s wi t h m i ni m e nt a l s t a t e e x a m s c o re s b e l o w cut - o f f p o i nt ( 2 3 p o i nt s ) [ 2 0 ] t o s e cu re re s e a r ch c re d i b i l i t y . F urt he rm o re , t he t ri a l wa s ca nc e l l e d f o r t he cl i e nt s wh o we r e t ra ns f e r re d t o a n o t he r un i t o r a no t h e r ho s p i t a l o r d i e d d ur i ng t he re s e a r ch p e r i o d . C l i e nt s we re i nc l ud e d i n t h i s a na l y s i s e v e n whe n m e e t i ng t h e
ca nc e l l a t i o n c r i t e ri a , b e ca u s e t he i n t e nt i o n t o t re a t p ri nc i p l e
wa s a p p l i e d t o g ua ra nt e e t h e co m p a ra b i l i t y o f ra nd o m i z e d
g ro up s .
R a nd o m i z a t i o n
C l i e nt s we r e ra nd o m l y a s s i g ne d t o t he e x p e ri m e nt a l o r co nt ro l g ro up us i ng b l o ck ra nd o m i z a t i o n. T he b l o c k s i z e wa s 4 t o re d uce t h e p r e d i ct a b i l i t y a nd e q u a l i z e t he t wo g ro up s . T o ho m o g e ni z e t h e i ni t i a l d a t a , ra nd o m i z a t i o n wa s p e rf o rm e d a f t e r d i v i s i o n b a s e d o n t he d i s e a s e g ro up ( ce r e b ro s p i na l o r
m us c ul o s ke l e t a l d i s e a s e ) a nd t he V i s ua l A na l o g S ca l e o n he a l t h i nc l ud e d i n E Q - 5 D ( E Q - V A S s co re ; h i g h o r l o w b a s e d o n 5 0 a s t he cut - o f f v a l ue ) [ 2 1 ] . I n t he p re s e nt s t ud y , we f o cu s e d o n t he cl i e nt ’ s s ub j e ct i v e e v a l ua t i o n o f o ut co m e s ; t he re f o re , we
a d o p t e d E Q - V A S t o ho m o g e ni z e t he d e g re e o f s ub j e ct i v e
e v a l ua t i o n o f he a l t h i n t he t w o g ro u p s . T h us , s t ra t i f i ca t i o n wa s a s f o l l o ws : 1 ) c e re b ro s p i na l d i s e a s e a nd h i g h E Q - V A S ; 2 )
ce re b ro s p i na l d i s e a s e a nd l o w E Q - V A S ; 3 ) m us c ul o s ke l e t a l d i s e a s e a nd hi g h E Q - V A S ; a nd 4 ) m us c ul o s ke l e t a l d i s e a s e a nd l o w E Q - V A S . T h e re a f t e r , cl i e nt s w e re ra nd o m l y a l l o ca t e d u s i ng co m p ut e r s o f t wa re ( R . V e r .3 .2 .1 ) .
T he p e rs o n a l l o ca t i ng t he cl i e nt s w a s n o t i f i e d r e g a rd i ng
t he a l l o ca t i o n g r o up v i a e - m a i l f r o m a ce nt ra l ra nd o m i z a t i o n
ce nt e r. A l t ho ug h t he s t a t i s t i c i a ns c re a t e d b l o c k ra nd o m
p a t t e rns f o r e a ch o f t h e f o u r l a y e rs , i n f o rm a t i o n a b o ut t he g ro up wa s m a s ke d . T he c hi e f r e s e a r che r i nf o rm e d t he 6 o cc up a t i o na l t he ra p i s t re s p o ns i b l e f o r t he cl i e nt r e g a rd i ng t re a t m e nt a s s i g nm e nt b ut d i d no t i nf o rm t h e cl i e nt . I n t he e x p e ri m e nt a l g ro up , a d e d i ca t e d m o b i l e t a b l e t a p p l i ca t i o n wa s us e d t o s up p o rt t he a p p ro a ch o f a d j ust i ng t he c ha lle ng e – s ki ll b a la nce b ut not u sed in t he cont rol g roup . T he p os sib il it y o f co nt a m i na t i o n wa s l i m i t e d b e t we e n t he g ro up s . T he p e rs o n co l l e ct i ng t he o ut co m e d a t a wa s a cq ua i nt e d w i t h cl i e nt a l l o ca t i o n .
P ro ce d u re s
Oc cup a t i o na l t he ra p y wa s co nd uct e d a cco rd i ng t o t he A m e ri ca n Oc cup a t i o na l T he ra p y A s s o ci a t i o n g ui d e l i ne s [ 2 2 ] b y o cc up a t i o na l t he ra p i s t s w i t h e x p e r i e nce o f cl i e nt - ce nt e re d p ra ct i c e ( a t l e a s t 2 0 0 wo rk h ) . T h e t he ra p i s t s we re t ra i ne d i n t he a p p ro a ch o f a d ju st i ng t he c ha lle ng e – s kil l b a la nc e (a t lea st 5 0 h) . B o t h g ro up s f o l l o we d t he g u i d e l i ne s a nd co nd uct e d
co m p re he n s i v e a s s e s s m e nt s a nd i nt e rv e nt i o n s f o r d o m a i ns s u c h
a s o cc up a t i o n s ( e .g ., a ct i v i t i e s o f d a i l y l i v i ng a nd i ns t rum e nt a l
a ct i v i t i e s o f d a i l y l i v i ng ) , cl i e nt f a c t o rs ( e .g . , b o d y f u nct i o n s a nd v a l ue ) , p e rf o rm a nc e s k i l l s ( e .g ., m o t o r a nd p ro ce s s s k i l l s ) , p e rf o rm a nce p a t t e r ns ( e .g . , ha b i t s a nd r o ut i ne s ) , a nd s i t ua t i o ns a nd e nv i r o nm e nt ( e .g ., b e ha v i o ra l s t a nd a rd s , e d u ca t i o na l a nd re s i d e nt i a l s t a t us , a s we l l a s ca re g i v e rs ) . T he m a i n d i f f e r e n ce b e t we e n t h e t wo g ro up s wa s i n wh e t he r t he cl i e nt s a nd t he t he ra p i s t s q ua nt i f i e d a nd s ha re d t h e p e r ce p t i o ns o f t a s k us i ng a co m m o n s ca l e , c ha l l e ng e a nd s ki l l l e v e l . T r e a t m e nt s i n e a c h g ro up co m p r i s e d s e s s i o n s l a s t i ng 4 0 – 6 0 m i n , co n d uct e d 6 t i m e s p e r we e k. T he t i m e f ro m p re - t o p o s t - a s s e s s m e nt wa s co ns i d e re d t he i m p l e m e nt a t i o n p e r i o d . D ur i ng t he f o l l o w - up p e ri o d , e a ch cl i e nt wa s i ns t ru ct e d t o d e d uc e t he a s s i g ne d g ro up i n re s p o ns e t o t he q ue s t i o nna i re p re p a re d f o r t h e p re s e nt s t ud y ( e .g ., D i d y o u kn o w t he t y p e o f re ha b i l i t a t i o n t ha t wa s p ro v i d e d ? ) . T h e p ro ce d ure s i n t he e x p e ri m e nt a l a nd co nt ro l g ro up s a re
s um m a r i z e d i n t he f o l l o wi ng s e ct i o n s .
E x p er im e nt a l g ro up
T he e x p e r i m e nt a l g r o up wa s s ub j e ct e d t o t he a p p r o a c h o f
a d just i ng t he c ha l le ng e – s ki ll b a la n ce us ing a d ed i ca t ed cu st om
a p p l i ca t i o n p r o g ra m . I n t he f i rs t s e s s i o n, t h e ra p i s t s us e d t h e C a na d i a n Oc cup a t i o na l P e rf o rm a n ce Me a s u re [ 8 ] t o e v a l ua t e cl i e nt ’ s i s s ue s w i t h s e v e ra l a ct i v i t i e s o f d a i l y l i v i ng . I n t he s e co nd s e s s i o n, c l i e nt s we re i ns t r u c t e d t o p e rf o rm t a s ks r e l a t e d t o t he s e l e c t e d a ct i v i t i e s , w hi ch r e f l e ct s t he a s s e s s m e nt b y t he t he ra p i s t . I n t he t hi rd s e s s i o n, c l i e nt s e v a l ua t e d t he i r
a ct i v i t i e s b a s e d o n c ha l l e ng e a nd s k i l l l e v e l . C ha l l e ng e l e v e l wa s d e f i n e d a s t h e cl i e nt ’ s p e r ce p t i o n o f t he a ct i v i t y ’ s d i f f i cu l t y a nd wa s e v a l ua t e d o n a s e v e n -p o i nt s ca l e f ro m “ e x t re m e l y
s i m p l e ” ( 1 ) t o “ e x t r e m e l y d i f f i c ul t ” ( 7 ) . “ S k i l l l e v e l ” wa s d e f i ne d a s t h e cl i e nt ’ s p e r ce p t i o n o f t he re q ui r e d s ki l l a s s o ci a t e d w i t h t he a ct i v i t y a nd wa s e v a l ua t e d f ro m “ no t a t a l l ” ( 1 ) t o
“ e x t re m e l y s ki l l e d ” ( 7 ) [ 1 3 ,2 3 ] . Mo r e o v e r , t he cl i e nt s we re i ns t ru ct e d t o j us t i f y t he i r s co re s b y t he t he ra p i s t s .
B a s e d o n t h e e v a l ua t i o n s b y t he c l i e nt a nd t he ra p i s t , t he f a ct o r s co nt ri b ut i ng t o d i f f i c ul t i e s wi t h t a s k p e rf o rm a n ce
( “ cha l l e ng i ng c o m p o ne nt s ” ; e .g . , e nv i ro nm e nt a l o r p hy s i ca l f a ct o r s , s uc h a s ra n g e o f m o v e m e nt , t i m e re q ui r e m e nt , p a i n, a nd f a t i g ue ) a nd i m p ro v i ng t a s k p e r f o rm a n ce ( “ s ki l l
co m p o ne nt ” ; e .g . , f re q ue n cy , ra ng e , d i s t a nc e , a c cu ra cy , a nd
d e x t e ri t y ) we re d e t e rm i ne d . C o m p e ns a t i o n a p p r o a c he s , s u ch a s e nv i ro nm e nt a l a d j u s t m e nt o r t h e us e o f t e c h n i ca l a i d s , we re p e rm i t t e d i n t he e x p e r i m e nt a l g ro u p t o a d j us t t he c ha l l e ng e l e v e l .
De p e nd i ng o n t he c ha l l e ng e – s ki l l b a l a nc e , t he t he ra p i s t
j ud g e d t he ne ce s s i t y t o re - a d j us t t h e a ct i v i t y . T h e cr i t e r i o n f o r
t hi s a d j u s t m e nt wa s a d i f f e re nce o f ≤1 b e t we e n t he cha l l e ng e
a nd s ki l l l e v e l s e v a l ua t e d b y t he t h e ra p i s t a nd cl i e nt . W he n t he
cl i e nt ’ s l e v e l s w e re b a l a n ce d , i nt e rv e nt i o n co ul d b e i ni t i a t e d . I f
t he re wa s a n i m b a l a n ce , t h e a ct i v i t y wa s r e - a d j us t e d unt i l t he
cha l l e ng e a nd s ki l l l e v e l s o f t he a ct i v i t y e v a l ua t e d b y t he cl i e nt
m e e t t he a b o v e c ri t e ri a . T he c ha l l e n g e a nd s ki l l co m p o n e nt s
we re co n s i d e re d t hro ug h o ut t he a s s e s s m e nt p r o ce s s . A f t e r t he
cl i e nt p e rf o rm e d t he a d j us t e d a ct i v i t y , t h e cl i e nt - re p o rt e d
cha l l e ng e a nd s ki l l l e v e l s we re re - e v a l ua t e d . T h e e v a l ua t i o n
a nd a d j u s t m e nt p ro ce s s e s we r e re p e a t e d a t l e a s t o nce a we e k
unt i l t he cha l l e ng e a nd s k i l l l e v e l s we re b a l a nce d f o r s e v e ra l
a ct i v i t i e s .
C o nt ro l g ro up
T he f i rs t a nd s e c o nd s e s s i o ns we re p e rf o rm e d s i m i l a r t o t ho s e o f t he e x p e ri m e nt a l g ro up . T h e co nt r o l g ro up d i d no t und e rg o t he s ub j e ct i v e e v a l ua t i o n o f t he c ha l l e ng e a nd s ki l l l e v e l s b y t he c l i e nt . T h e re f o re , f o l l o wi ng t h e t hi rd s e s s i o n , t he t he ra p i s t a s s e s s e d t he cl i e nt a nd p r o v i d e d t he ra p y b a s e d o n t he g e ne ra l g ui d e l i n e s f o r o cc up a t i o na l t he ra p y p ra ct i ce [ 2 2 ] .
O ut co m e s
T he p ri m a ry o ut co m e wa s t he s ub j e ct i v e q ua l i t y o f l i f e
m e a s ur e d us i ng t he I ki g a i - 9 s co re [ 2 4 ] . T he s e co nd a ry o ut c o m e s
we re m e a s u re d us i ng t he he a l t h - re l a t e d q ua l i t y o f l i f e ( E Q - 5 D -
5 L ) [ 2 1 ] , t he F l o w S t a t e S ca l e f o r O cc up a t i o na l T a s k s [ 2 5 ] , a nd
t he F un ct i o na l I nd e p e nd e n ce Me a s u re [ 2 6 ] . T h e I ki g a i - 9 a nd
E Q - 5 D- 5 L we re m e a s u re d a t t h e p re - , p o s t - , a nd f o l l o w - up
a s s e s s m e nt s , b ut t he F l o w S t a t e S c a l e f o r O cc up a t i o na l T a s k s
a nd t he F un ct i o na l I nd e p e nd e nc e M e a s u re we re o nl y m e a s u re d
a t t he p re - a nd p o s t - a s s e s s m e nt s . D uri ng t he f o l l o w - up p e ri o d ,
we s e nt s e l f - e v a l ua t i o n f o rm o n o ut co m e s ( I k i g a i - 9 a nd E Q - 5 D -
5 L ) t o t he c l i e nt ’ s re s i d e nce a nd re q ue s t e d a re s p o ns e .
T he I ki g a i - 9 i s a s e l f - f i l l e d q u e s t i o n na i r e m e a s u ri ng t h e m e nt a l s t a t e “ re a s o n f o r l i v i ng ; I ki g a i ” . I ki g a i - 9 i nv o l v e s t he f o l l o wi ng t hre e f a ct o r s : 1 ) o p t i m i s t i c a nd p o s i t i v e f e e l i ng s f o r l i f e ; 2 ) p o s i t i v e a nd a ct i v e a t t i t ud e t o wa rd t he f ut ure ; a nd 3 ) re co g ni t i o n o f t he m e a ni ng o f s e l f - e x i s t e n ce . T he s e t hr e e f a ct o r s we re e v a l ua t e d u s i ng t h re e q ue s t i o ns e a ch ( n i n e
q ue s t i o ns i n t o t a l ) a nd s co re d us i ng a 5 - p o i nt L i ke rt s ca l e f r o m
“ s t ro ng l y d i s a g r e e ” ( 1 p o i nt ) t o “ s t r o ng l y a g re e ” ( 5 p o i nt s ) , wi t h a t o t a l s co re o f 9 – 4 5 p o i nt s ( T a b l e 1 ) . T he C ro nb a c h’ s a l p ha o f I ki g a i - 9 wa s 0 .8 7 [ 2 4 ] .
T he E Q - 5 D- 5 L d e f i ne s he a l t h co nd i t i o n s b a s e d o n f i v e d i m e ns i o n s ( e .g ., m o b i l i t y , s e l f - ca re , us ua l a ct i v i t i e s ,
p a i n/d i s co m f o rt , a nd a nx i e t y /d e p re s s i o n) a nd p r o v i d e s a ut i l i t y i nd e x , w hi ch ca n b e us e d i n co s t - e f f e ct i v e ne s s a na l y s e s [ 2 7 ] . Mo re o v e r , we u s e d t he E Q - V A S f o r t he s e l f - a s s e s s m e nt o f he a l t h c o nd i t i o n f ro m “ wo r s t ” ( 0 ) t o “ b e s t ” ( 1 0 0 ) . T e s t – re t e s t re l i a b i l i t y f o r E Q - 5 D - 5 L wa s r = 0 .9 0 a nd t ha t f o r E Q - V A S wa s r = 0 .8 6 [ 2 1 ] .
F l o w e x p e ri e nce wa s e v a l ua t e d u s i n g t he F l o w S t a t e S ca l e
f o r O cc up a t i o na l T a s k s , w hi ch wa s d e v e l o p e d a s a m e a s u re
b a s e d o n f a ct o r s t ha t a re co ns i d e re d t o b e c o m p o ne nt s o f t he f l o w . I t co m p ri s e s t hr e e f a ct o rs t ha t i nd i ca t e t he “ s e ns e o f co nt ro l o f t he t a s k” ( 6 i t e m s ) , “ e x p e ri e nce o f p o s i t i v e e m o t i o n”
( 4 i t e m s ) , a nd “ e x p e ri e n ce o f a b s o rp t i o n b y c o n ce nt ra t i ng o n a t a s k” ( 4 i t e m s ) . T he i t e m s w e re m e a s ur e d i n a 7 - p o i nt s ca l e ra ng i ng f ro m “ s t r o ng d i s a g re e m e nt ” ( 1 ) t o “ s t ro ng a g r e e m e nt ” ( 7 ) , wi t h a t o t a l s c o re ra ng i ng f ro m 7 t o 9 8 p o i nt s . T he hi g h s co re i s co ns i d e re d t o i nd i ca t e t he s t ro ng f l o w s t a t e i n
p e rf o rm i ng a s p e ci f i c t a s k. T he C ro nb a ch’ s a l p ha wa s 0 .9 2 [ 2 5 ] . T he a ct i v i t i e s o f d a i l y l i v i ng w e re m e a s ur e d us i ng t he
F un ct i o na l I nd e p e nd e nc e Me a s ur e , e v a l ua t i ng 1 8 i t e m s o n m o t o r a nd co g n i t i v e s ub s ca l e s i n 7 g ra d e s . T he t o t a l s co re ra ng e s f ro m 1 8 , i nd i ca t i ng t he ne e d f o r f ul l a s s i s t a nc e , t o 1 2 6 , i nd i ca t i ng f u l l i nd e p e nd e nce . I nt ra c l a s s co rr e l a t i o n co e f f i ci e nt wa s 0 .9 6 [ 2 6 ] .
S a m p l e S i z e
A n a p ri o ri p o we r a na l y s i s wa s co nd uct e d ( G* p o we r,
v e rs i o n 3 .1 .7 ) b a s e d o n t he e f f e ct s i z e o f 0 .7 6 f o r E Q - 5 D - 5 L [ 1 6 ]
a nd 0 .7 8 f o r I k i g a i - 9 [ 1 7 ] i n p re v i o u s r e s e a rc h. A s a m p l e s i z e o f
6 8 wa s r e q ui re d t o a c hi e v e a n e f f e ct s i z e o f 0 .7 i n t he q ua l i t y o f l i f e s co r e , a n a l p ha l e v e l o f 0 .0 5 ( t w o - s i d e d ) , a nd a n 8 0 % p o we r t o d e t e ct t he d i f f e re nc e .
S t a t i s t i ca l A na l y s i s
A l l d a t a we r e e nt e re d i nt o Mi cr o s o f t E x ce l 2 0 1 6 b e f o re b e i ng e x p o rt e d t o I B M S P S S v e rs i o n 2 4 o r R v e r s i o n 3 .4 .1 f o r a na l y s i s b y s t a t i s t i c i a n s wh o we r e una wa re o f g ro up a l l o ca t i o n . S P S S wa s p ri m a r i l y u s e d f o r o ut co m e a na l y s i s a nd R wa s u s e d t o ca l cu l a t e co s t - e f f e ct i v e ne s s . T he b a s e l i ne cha ra ct e ri s t i c s o f t he g ro up s we r e a na l y z e d u s i ng e f f e ct s i z e s . Mo re o v e r , t he a ct i v i t i e s s up p o rt e d b y b o t h g ro up s we re ca t e g o r i z e d a nd co m p a re d .
T he p ri m a ry a nd s e co nd a ry o ut co m e s we re a na l y z e d us i ng
a l i ne a r m i x e d m o d e l f o r r e p e a t e d m e a s u re s w i t h a m a x i m um
l i k e l i ho o d e s t i m a t e . I n t hi s m o d e l , g ro up ( e x p e r i m e nt a l o r
co nt ro l ) , t i m e ( p re - , p o s t - , o r f o l l o w - up a s s e s s m e nt ) , a nd t he
g ro up a nd t i m e i nt e ra ct i o n we re co n s i d e re d a s f i x e d e f f e ct s a nd
cl i e nt s w e re c o n s i d e r e d a s ra nd o m e f f e ct s . T i m e wa s co n s i d e re d
a s a re p e a t e d m e a s u re . A p - v a l u e o f < 0 .0 5 u s i ng t y p e I I I f i x e d
e f f e ct s wa s co ns i d e re d s i g ni f i ca nt . T hi s wa s re p o rt e d t o b e a n a p p ro p ri a t e s t a t i s t i ca l m e t h o d f o r a l o ng i t ud i na l t r i a l wi t h m i s s i ng d a t a [ 2 8 ] . T he m a g ni t ud e o f t he b e t w e e n - g ro up e f f e ct wa s d e t e rm i ne d a s t he e f f e ct s i z e b a s e d o n H e d g e s ’ g f or ea c h o ut co m e [ 2 9 ] , ca l cul a t e d b y d i v i d i ng t he d i f f e re nce b e t we e n t h e m e a ns o f e a c h g ro up b y t he p o o l e d s t a nd a rd d e v i a t i o n .
A cco rd i ng t o t he s t a nd a rd i z e d c ri t e ri a f ro m p re v i o u s s t ud i e s o n e f f e ct s i z e s , 0 .2 ca n b e co ns i d e re d a s s m a l l , 0 .5 a s m e d i um , a nd 0 .8 a s l a rg e [ 2 9 ] .
A co s t - e f f e ct i v e ne s s a na l y s i s wa s co nd uct e d u s i ng t o t a l co s t a nd q ua l i t y - a d j u s t e d l i f e - y e a r b a s e d o n t he ut i l i t y v a l ue o f t he E Q - 5 D- 5 L [ 2 7 ] . T he i nc re m e nt a l co s t - e f f e ct i v e ne s s ra t i o wa s ca l c ul a t e d b a s e d o n a co m p a ri s o n o f t he s t ud y g r o up s f ro m
d i s c ha rg e t o t he f o l l o w - up a s s e s s m e nt . T he f i na nci a l d a t a we r e ca l c ul a t e d a cc o rd i ng t o t h e re ha b i l i t a t i o n co s t r e g i s t e re d i n t h e e l e ct ro n i c m e d i ca l re co rd . T he t o t a l co s t wa s co nv e rt e d t o U S d o l l a r s us i ng t he a v e ra g e e x cha ng e ra t e a t t he t i m e o f d a t a a na l y s i s . T he i n cr e m e nt a l c o s t - e f f e c t i v e ne s s ra t i o wa s
ca l c ul a t e d a s [ C o E − C o C ] /[ E f E − E f C ] , whe re C o i s t he m e a n
co s t , E f i s t he m e a n q ua l i t y - a d j u s t e d l i f e - y e a r , E i s t h e
e x p e ri m e nt a l g ro up , a nd C i s t h e co nt ro l g ro up . T o co n s i d e r t he un ce rt a i nt y o f t he i n cr e m e nt a l co s t - e f f e ct i v e n e s s ra t i o , t h e m e a n wa s ca l cu l a t e d us i ng t he b o o t s t ra p m e t ho d ( 1 ,0 0 0 t i m e s ) , whi ch re s a m p l e s f ro m t he o b s e rv e d d a t a a nd e x p e ri m e nt a l l y f o rm s i t s d i s t ri b ut i o n us i ng t he s e s t a t i s t i c s [ 3 0 ] .
R e s u l t s
W e t a rg e t e d 7 2 cl i e nt s f o r ra nd o m a s s i g nm e nt ( F i g u re 1 ) . A m o ng t h e m , 6 0 i nd i v i d ua l s w e re a b l e t o p a rt i ci p a t e t ho r o ug h t he e nt i re s t ud y p e ri o d up t o t he f o l l o w - up a s s e s s m e nt . T h e cha ra ct e ri s t i cs o f t h e cl i e nt s i n t he t wo g ro up s m a t c he d s a t i s f a ct o r i l y a t t he i ni t i a l e v a l ua t i o n ( T a b l e 2 ) . T he
o cc up a t i o na l t he ra p y p ro v i d e d i n t h e p re s e nt s t ud y wa s 4 4 .3 ± 3 6 .0 s e s s i o n s i n t he e x p e ri m e nt a l g r o up a nd 4 3 .6 ± 2 8 . 2
s e s s i o ns i n t h e co nt ro l g r o up ( 4 0 m i n wa s co ns i d e re d a s o ne s e s s i o n) . T a rg e t e d a ct i v i t i e s we re c o m p a ra b l e b e t we e n t he t wo g ro up s ( T a b l e 3 ) .
T he p re - , p o s t - , a nd f o l l o w - up a s s e s s m e nt s c o re s a s we l l
a s t h e cha ng e s co re s o f e a ch o ut co m e a re s ho wn i n T a b l e 4 . T he
re s ul t s o f t he l i ne a r m i x e d m o d e l a r e s ho w n i n T a b l e 5 a nd
F i g u re 2 . A s s ho wn , a s i g n i f i ca nt d i f f e re nc e wa s o b s e rv e d b e t we e n t h e t wo g ro up s i n t h e I ki g a i - 9 s co re . R e g a rd i ng t he s e co nd a ry o ut co m e s , t he re wa s a s i g ni f i ca nt d i f f e re nce b e t we e n t he t wo g ro up s i n t he E Q - 5 D - 5 L b ut no t f o r e i t he r t he F l o w S t a t e S ca l e f o r Oc cup a t i o na l T a s k s o r t he F u nct i o na l
I nd e p e nd e n ce Me a s u re . F urt he rm o r e , i t a p p e a r s t ha t f o r t he I ki g a i - 9 a nd E Q - 5 D - 5 L , t h e e x p e ri m e nt a l g ro up re p o rt e d h i g he r s co re s d u ri ng t he p o s t - a s s e s s m e nt p e ri o d b ut t he s e d e cr e a s e d d uri ng t he f o l l o w - up p e ri o d . T he e f f e ct s i z e s b a s e d o n t he cha ng e s i n t he p re – p o s t - a s s e s s m e nt re s u l t s we re 0 .7 6 ( 9 5 % C I : 0 .2 7 – 1 .2 4 ) , 0 .6 2 ( 9 5 % C I : 0 .1 4 – 1 .1 0 ) , − 0 .0 9 ( 9 5 % C I : − 0 .5 6 – 0 .3 7 ) , a nd 0 .2 5 ( 9 5 % C I : − 0 .2 1 – 0 .7 2 ) f o r t h e I k i g a i - 9 , E Q - 5 D- 5 L , F l o w S t a t e S ca l e f o r Oc cup a t i o na l T a s k s , a nd t he F u nct i o na l
I nd e p e nd e n ce Me a s u re , re s p e ct i v e l y .
De s p i t e b l i nd i ng , 9 cl i e nt s ( 3 1 .0 % ) i n t he e x p e ri m e nt a l g ro up a nd 7 ( 2 2 .6 % ) i n t he c o nt r o l g ro up [ o v e ra l l 1 6 ( 2 6 .7 % ) ] we re a wa re o f t he i r a s s i g nm e nt , w h e re a s t he re m a i n i ng c l i e nt s re p o rt e d s uc ce s s f u l b l i nd i ng .
R e g a rd i ng t he c o s t - e f f e ct i v e n e s s a n a l y s i s , q ua l i t y -
a d j us t e d l i f e - y e a r wa s ca l cu l a t e d b a s e d o n t he E Q - 5 D - 5 L d a t a
us i ng a U S d o l l a r t o y e n e x c ha ng e r a t e o f $ 1 t o 1 1 1 .1 0 y e n. T he co s t o f t re a t m e nt i n t he e x p e r i m e nt a l g r o up wa s $ 1 ,7 1 0 .8 6 , whe re a s t ha t i n t he co nt ro l g ro up w a s $ 1 ,6 5 9 .4 6 . T h i s p ro d u ce d q ua l i t y - a d j us t e d l i f e - y e a r o f 0 .1 7 3 a nd 0 .1 6 4 i n t h e
e x p e ri m e nt a l a nd co nt ro l g r o up s , re s p e ct i v e l y . T he i n cre m e nt a l co s t - e f f e ct i v e ne s s ra t i o , b a s e d o n t h e b o o t s t ra p m e t ho d , wa s
$ 5 ,5 1 8 .3 8 p e r q ua l i t y a d j u s t e d l i f e y e a r.
D i s cu s s i o n
I n t he p r e s e nt s t ud y , w e e x a m i ne d t he e f f e ct o f us i ng t he a p p ro a ch o f a d ju st ing t h e cha l le ng e – ski ll b a la n ce in t he
re ha b i l i t a t i o n p ro c e s s a nd o b s e rv e d t ha t t he s ub j e ct i v e q ua l i t y
o f l i f e [ p ri m a ry o ut c o m e ( I ki g a i - 9 s c o re ) ] a nd he a l t h - re l a t e d
q ua l i t y o f l i f e [ s e c o nd a ry o ut co m e ( E Q - 5 D- 5 L ) ] i m p ro v e d
b e t we e n a d m i s s i o n t o d i s c ha rg e , a n d t he e f f e ct s i z e o f e a ch
o ut co m e wa s m o d e ra t e . H o we v e r , t h e re we re no s i g ni f i ca nt
d i f f e re nc e s i n t he g ro up s wi t h re s p e ct t o c ha ng e s i n f l o w
e x p e ri e nc e a nd i nd e p e nd e nce i n t he a ct i v i t i e s o f d a i l y l i v i ng .
F urt he rm o re , t he i n cr e m e nt a l co s t - t o - e f f e ct i v e ne s s ra t i o o f t he
a p p ro a ch o f a d ju st in g t h e cha l le ng e – ski ll b a la n ce, whi ch wa s
ca l c ul a t e d us i ng q ua l i t y - a d j us t e d l i f e - y e a r b a s e d o n t h e ut i l i t y i nd e x o f E Q - 5 D - 5 L , wa s $ 5 ,5 1 8 .3 8 c o m p a re d w i t h t he s t a nd a rd o cc up a t i o na l t he ra p y , i nd i ca t i ng t h a t re ha b i l i t a t i o n u s i ng
a d just i ng t he c ha lle ng e – s ki ll b a la n ce wa s a m o re co st - eff ect iv e m e t ho d t ha n t he co nv e nt i o na l re ha b i l i t a t i o n ( o c cup a t i o na l
t he ra p y ) .
I n t he p r e s e nt s t ud y , a d j ust i ng t he cha l leng e – s kil l b a la nce wa s d e sig ned t o s ha re t h e r eha b il it a t ion p ro ce ss wit h cl i e nt s a nd t o p ro m o t e t a s k s s u i t a b l e w hi ch h e l p cl i e nt s
m a i nt a i n i ng p o s i t i v e m e nt a l a t t i t ud e a nd t o co n f i rm t h e e f f e ct o f t h i s a p p ro a c h, t h e s ub j e ct i v e q ua l i t y o f l i f e ( e v a l ua t e d us i ng t he I ki g a i - 9 s co re ) wa s a d o p t e d a s t he p ri m a ry o ut co m e .
S e v e ra l cl i e nt s p a rt i ci p a t i ng i n re h a b i l i t a t i o n p r o g ra m s ha v e m ul t i f a ct o r i a l a nd co m p l e x i s s u e s [ 3 1 ] .T h e re e x i s t s a co n ce rn t ha t i f t he a ct i v i t y i s s up p o rt e d wi t ho ut s uf f i ci e nt re a s o n f o r t he co m p l e x i t y , t he a ct i v i t y m a y b e m a t che d t o a nx i e t y o r b o re d o m i n t he f l o w m o d e l [ 1 2 ] . B y a d j us t i ng t he c ha l l e ng e – s ki l l b a l a n ce t o t he a ct i v i t y o f t he c l i e nt , t he o c cu rr e n ce o f ne g a t i v e e m o t i o ns , s u ch a s a nx i e t y a nd b o r e d o m , wa s
s up p re s s e d . I t ha s b e e n s p e c ul a t e d t ha t t h i s o c cu rr e n ce wa s
re l a t i v e l y i nv o l v e d i n e n ha n ci ng t he s ub j e ct i v e q ua l i t y o f l i f e ( I ki g a i - 9 ) . I n o t he r wo rd s , w e b e l i e v e t ha t a d j u s t i ng t h e
cha l l e ng e – s ki l l b a l a nce co nt ri b ut e s t o f o cu s i ng o n t he t a s k i t s e l f a nd a v o i d i ng d i s t ra ct i o n b y t h e t a s k un re l a t e d t ho ug ht s ( m i nd - wa nd e r i ng ) [ 3 2 ] . A l t ho ug h t h i s re m a i ns hy p o t he t i ca l , co n s i d e ri ng t h e re p o rt t ha t m i nd - wa nd e ri ng i s re d uc e d b y t he s t a t e o f m i nd f ul ne s s [ 3 3 ] , t h e a d d i t i o n o f a d j ust ing t he
cha l leng e – s kil l b a la nce i n re ha b ilit a t ion m a y ha v e l ed t o a s t a t e s i m i l a r t o m i nd f ul ne s s . W e i nt e nd t o i nv e s t i g a t e t h e
re l a t i o ns hi p b e t we e n a d ju st ing t h e cha l leng e - s ki ll b a la n ce a nd m i nd - wa nd e r i ng o r m i nd f u l ne s s i n t he f ut u re .
R e p e a t i ng t he a p p r o a c h o f a d j ust i ng t he c ha ll eng e – sk ill b a la nce a l so help s t o id e nt ify t he t a sk w hi ch s hou ld b e set
a cco rd i ng t o t he c ha ng i ng s ki l l b y t he t he ra p y w hi l e f o c us i ng o n a chi e v a b l e g o a l s a t t ha t t i m e . T he f e a t ure s o f t hi s a p p ro a ch a re s i m i l a r t o t h e s m a l l - s t e p m e t ho d [ 3 4 ] . R e ha b i l i t a t i o n o f t e n
re q u i re s t he a ch i e v e m e nt o f i t s g o a l s wi t h i n a l i m i t e d p e ri o d i n
cu rre nt he a l t h ca re s y s t e m s [ 3 5 ] ; t h e re f o re , i n ca s e s w he r e t he
cl i e nt s ’ a b i l i t i e s a nd l i f e g o a l s a re g re a t l y d i v e r s e , t h e re e x i s t s
a co nce r n t ha t t h i s a p p ro a c h ca n no t a c hi e v e t he g o a l . T h e
p re s e nt s t ud y d e m o ns t ra t e d no s i g n i f i ca nt d i f f e r e n ce b e t we e n t he g ro up s wi t h re g a rd t o t he ho s p i t a l i z a t i o n p e ri o d a s we l l a s t he i m p ro v e m e nt o f t he F u nct i o na l I nd e p e nd e n ce Me a s u re , whe re a s t h e E Q - 5 D- 5 L t e nd e d t o i m p ro v e i n t he e x p e ri m e nt a l g ro up , t he r e b y s ug g e s t i ng t ha t re ha b i l i t a t i o n us i ng a d ju st ing t he cha l le ng e – s kil l b a la nc e , w hi ch i s s im ila r t o sm a l l st ep s , i nc re a s e s he a l t h - re l a t e d q ua l i t y o f l i f e wi t ho ut a ny a d v e r s e e f f e ct s o n t he a ct i v i t i e s o f d a i l y l i v i ng p e rf o rm a nc e a s we l l a s o n t he ho s p i t a l i z a t i o n p e r i o d .
I nt e re s t i ng l y , t he re wa s no d i f f e re n ce b e t we e n t he g ro up s wi t h r e g a rd t o t h e f l o w s t a t e b a s e d o n t he F l o w S t a t e S ca l e f o r O cc up a t i o na l T a s k s , d e s p i t e t he f a ct t ha t ro ut i ne l y i nv o l v i ng t he cl i e nt s i n s e l f - a s s e s s m e nt co u l d ha v e i n cre a s e d t he i r e ng a g e m e nt i n t he t he ra p e ut i c p ro ce s s . A p o s s i b l e
e x p l a na t i o n i s t ha t a s t a t e o f d e e p f l o w [ 3 6 ] wa s n o t a c hi e v e d , b e ca u s e we a i m e d t o o nl y a d j u s t t h e c ha l l e ng e – s ki l l b a l a n ce . A l t ho ug h t he a p p ro a c h o f a d j ust ing t he cha l le ng e – s kil l b a la nc e i s b a s e d o n f l o w m o d e l , t he w i d e r b e ne f i t s o f t hi s a p p ro a c h m a y ha v e e s s e nt i a l l y b e e n o b t a i ne d f ro m o t he r f a ct o rs , s u ch a s
re d u ct i o n i n m i nd - wa nd e ri ng a nd e m p l o y i ng s m a l l - s t e p m e t ho d .
I t a p p e a rs t ha t f o r t he I ki g a i - 9 a nd E Q - 5 D- 5 L , t he e x p e ri m e nt a l g ro up r e p o rt e d hi g he r s c o re s d ur i ng t he p o s t -
a s s e s s m e nt p e r i o d b ut t he s e re t u rn e d t o a l m o s t p re - a s s e s s m e nt v a l ue s a t t he f o l l o w - up a s s e s s m e nt . A l t ho ug h t he a p p ro a c h o f a d j us t i ng t he b a l a n ce b e t we e n t he c l i e nt ’ s cha l l e ng e a nd s k i l l wa s re p e a t e d d ur i ng ho s p i t a l i z a t i o n , i t a p p e a re d t o b e d i f f i c ul t f o r t he c l i e nt t o co nt i nue t h e a p p ro a ch o n t he i r o wn a t ho m e . T he r e f o re , e v e n i f t he a p p ro a c h o f a d just i ng t he c ha lle ng e – sk ill b a la nce i s im p lem ent ed o nce , t he s u st a ined effe ct in t he hom e l i f e e nv i ro nm e nt wi t h o ut a s s i s t a n ce f o r t h i s a p p ro a c h re m a i ns unv e ri f i e d . I n t he f ut ur e , i t wi l l b e b e ne f i ci a l t o v e r i f y t he e f f e ct i v e n e s s o f t h i s a p p ro a c h i n t h e c l i e nt ’ s ho m e l i f e e nv i ro nm e nt a nd e s t a b l i s h a s y s t e m t ha t e na b l e s t he
co nt i n ua t i o n o f t h i s a p p ro a c h o f a d j ust i ng t he c ha lle ng e – s ki ll b a la nce t o wa rd f oll ow - up o f hom e li fe a ft e r d i sc ha rg e .
T he p re s e nt s t ud y ha s s e v e ra l l i m i t a t i o ns . F i r s t , t h e s t ud y wa s p e rf o rm e d a t a s i ng l e f a c i l i t y , whi ch m i g ht i n cre a s e t he t re a t m e nt e f f e ct co m p a r e d w i t h t ha t o b s e rv e d wi t h
m ul t i c e nt e r ra nd o m i z e d co nt ro l l e d t ri a l d e s i g ns . S e co nd ,
b e ca u s e t he t he ra p i s t s w e re t ra i ne d f o r a d m i n i s t e ri ng t he
a p p ro a ch o f a d j u s t i ng t h e cha l l e ng e – s ki l l b a l a n ce , i t m a y ha v e b i a s e d t he i nt e rv e nt i o n i n t he t wo g ro up s . I n a d d i t i o n , a l t ho ug h t he t he ra p i s t s we re no t b l i nd e d a nd t he c l i e nt s we re s i ng l e -
b l i nd e d , o nl y 7 3 .3 % o f t he c l i e nt s w e re s u cc e s s f u l l y b l i nd e d . De s p i t e t h e p o t e nt i a l f o r b i a s , w e b e l i e v e t ha t t he n o n - b l i nd e d cl i e nt s ( 2 3 .7 % ) d i d no t ha v e a s t r o n g i m p a ct o n t he r e s ul t s . T hi rd , t he e x t e nt t o w hi ch t he a p p r o a ch o f a d ju st i ng t h e
cha l leng e – s kil l b a la nce wa s a b le t o ob t a in t he effe ct s d es cr ib ed b y t he f l o w m o d e l a nd l e a d t o t he f l o w e x p e ri e n ce i n t h i s s t ud y re m a i n s un cl e a r. Mo re o v e r , we ha v e p re v i o u s l y co nd u ct e d a s t ud y a t a n a d ul t d a y p ro g ra m , b ut t he p r e s e nt s t ud y wa s o nl y co nd uct e d i n a re co v e ry re ha b i l i t a t i o n un i t . T h e re f o r e , t he
e f f e ct s ha v e no t b e e n v e ri f i e d i n a c ut e , s ub a c ut e , o ut p a t i e nt , o r ho m e v i s i t s a s we l l a s i n f o l l o w - up a t ho m e l i f e e nv i ro nm e nt , a s d e s cr i b e d a b o v e . T h e s e i s s u e s s ho u l d b e co n s i d e re d i n f ut ure re s e a rc h.
I n c o n cl u s i o n , we s ug g e s t e d t ha t us i ng t he a p p ro a c h o f a d just i ng t he c ha lle ng e – s ki ll b a la n ce in re ha b il it a t io n
i m p ro v e s t h e s ub j e ct i v e q ua l i t y o f l i f e o f t h e cl i e nt .
C l i n i ca l M e s s a g e s
• U s i ng a d j ust i ng t he c ha ll eng e – sk ill b a la nce i n t he
re ha b i l i t a t i o n p ro c e s s m a y i m p ro v e t he cl i e nt ’ s s ub j e ct i v e q ua l i t y o f l i f e .
• A d just i ng t he c ha lle ng e – s ki ll b a la n ce m a y b e a u sef ul a nd co s t - e f f e ct i v e a p p ro a c h f o r c l i e nt s i n t he re co v e ry
re ha b i l i t a t i o n un i t wh e n co m p a r e d wi t h c o nv e nt i o na l
o cc up a t i o n a l t he ra p y .
A ck no w l e d g e m e nt s : W e a p p re ci a t e a l l t he p e o p l e w ho co o p e ra t e d i n t hi s r e s e a rc h.
C o m p e t i ng i nt e re s t s : N o ne d e cl a re d .
S o u rce o f f u nd i ng : T hi s s t ud y wa s s up p o rt e d b y t h e J a p a ne s e A s s o c i a t i o n o f Oc cup a t i o na l T he ra p i s t s ( g ra nt n um b e r 2 0 1 7 - 0 4 ) .
C o nt ri b ut o r s : I Y d e s i g ne d a nd p e r f o rm e d t h e re s e a rc h . I Y a nd KH a na l y z e d d a t a . I Y d ra f t e d t he p a p e r. KH a nd R K re v i e w e d a nd m o d i f i e d t h e m a nu s c ri p t . A l l a u t ho r s ha v e re a d a nd
a p p ro v e d t he f i na l m a n us cri p t .
S up p l e m e nt a ry Ma t e ri a l s : Da t a wi l l b e m a d e a v a i l a b l e o n
re q ue s t .
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T a b l e 1 . I t e m s o f I ki g a i - 9
I ki g a i - 9 co m p ri s e s ni ne i t e m s ( t hre e f a ct o rs ) . T h e t hre e f a ct o r s a re a s f o l l o ws :o p t i m i s t i c a nd p o s i t i v e f e e l i ng s f o r l i f e ( 1 , 4 , a nd 7 ) , p o s i t i v e a nd a ct i v e a t t i t ud e t o w a rd t he f ut u re ( 2 , 5 , a nd 8 ) ,
a nd re co g ni t i o n o f t he m e a n i ng o f s e l f - e x i s t e nce ( 3 , 6 , a nd 9 ) .
T a b l e 2 . C ha ra ct e r i s t i c s o f t he cl i e nt s a t t he i ni t i a l e v a l ua t i o n ( n = 7 2 )
Ov e ra l l , 3 6 cl i e nt s we r e a s s i g ne d t o b o t h t he e x p e ri m e nt a l a nd co nt ro l g ro up s . B o t h g ro up s we re d i v i d e d b a s e d o n t he d i s e a s e g ro up ( c e re b ro s p i na l o r m u s c ul o s ke l e t a l d i s e a s e ) a nd t he V i s ua l
A na l o g S ca l e o n he a l t h i n cl ud e d i n E Q - 5 D ( s t ra t i f i ca t i o n) , a nd ra nd o m a l l o ca t i o n wa s p e rf o rm e d t o a c hi e v e h o m o g e n i z a t i o n. N o
s i g n i f i ca nt e f f e ct wa s o b s e rv e d a t e a ch i n i t i a l v a l u e .
Cerebrospinal and high EQ-VAS
(n = 11)
Cerebrospinal and low EQ-VAS (n = 3)
Musculoskeletal and high EQ-VAS (n = 13)
Musculoskeletal and low EQ-VAS (n = 9)
Cerebrospinal and high EQ-VAS
(n = 12)
Cerebrospinal and low EQ-VAS (n = 4)
Musculoskeletal and high EQ-VAS (n = 12)
Musculoskeletal and low EQ-VAS (n = 8)
67.00 (6.43) 71.67 (4.58) 71.67 (4.58) 78.89 (7.67) 74.11 (9.11) 72.75 (11.73) 68.75 (7.63) 76.50 (9.28) 79.88 (7.59) 75.17 (9.99) g = 0.11
Male 5 1 3 3 12 8 3 2 2 15
Female 6 2 10 6 24 4 1 10 6 21
Disease, n
Cerebral infarction 7 2 - - 9 9 3 - - 12
Cerebral hemorrhage 2 - - - 2 2 1 - - 3
Subarachnoid hemorrhage 1 - - - 1 1 - - - 1
Spinal cord injury 1 1 - - 2 - - - - -
Femoral neck fracture - - 3 2 5 - - 1 - 1
Intertrochanteric femoral fracture - - 2 3 5 - - 3 2 5
Lumbar compression fracture - - 2 3 5 - - 1 2 3
Pelvic fracture - - - 1 1 - - 2 2 4
Lumbar spinal canal stenosis - - - - 5 - - - 1 1
Knee osteoarthritis - - 5 - - - - 5 - 5
Hip osteoarthritis - - - - - - - - 1 1
Above knee amputation - - 1 - 1 - - - - -
Length of stay (Day), Mean (SD) 47.82 (30.92) 87.00 (39.36) 43.2 (33.70) 38.67 (26.22) 49.47 (33.05) 42.25 (27.54) 72.75 (39.00) 36.92 (20.44) 56.63 (26.61) 49.53 (27.99) g = 0.00
Treatment period (Day), Mean (SD) 45.33 (31.41) 84.86 (38.04) 41.68 (33.24) 36.59 (27.08) 47.14 (32.69) 40.96 (26.73) 69.98 (38.48) 34.61 (21.03) 54.09 (25.67) 47.06 (27.95) g = 0.00
MMSE, Mean (SD) 26.73 (2.61) 29.33 (1.15) 27.92 (2.36) 26.56 (2.74) 27.33 (2.53) 28.25 (1.71) 25.25 (1.89) 27.50 (2.58) 27.25 (2.38) 27.36 (2.46) g = 0.01
EQ-VAS, Mean (SD) 75.64 (11.42) 30.00 (10.00) 68.08 (17.14) 33.89 (11.67) 58.67 (22.95) 78.08 (9.07) 46.25 (11.09) 72.92 (18.02) 39.38 (10.16) 65.33 (20.72) g = 0.30
79.36 (12.73) 79.33 (6.43) 80.31 (9.31) 78.78 (13.21) 79.56 (10.90) 75.67 (12.29) 50.5 (15.93) 82.5 (12.81) 77.13 (11.19) 75.47 (15.32) g = 0.31
Ikigai-9, Mean (SD) 29.45 (7.35) 20.33 (4.73) 29.92 (4.25) 26.00 (8.44) 28.00 (6.88) 26.41 (9.20) 25.00 (6.37) 32.33 (6.54) 30.63 (12.26) 29.17 (9.06) g = 0.15
Motor 69.18 (13.63) 58.67 (25.42) 62.69 (13.93) 63.22 (12.57) 64.47 (14.29) 72.41 (11.22) 57.00 (23.85) 67.92 (10.30) 55.88 (15.96) 65.53 (14.85) g = 0.07
Cognitive 31.27 (3.17) 34.67 (0.58) 33.23 (2.83) 34.00 (1.41) 32.97 (2.76) 33.67 (2.02) 29.00 (4.69) 34.83 (0.58) 33.75 (1.83) 33.56 (2.62) g = 0.22
Total 100.45 (14.45) 93.67 (25.42) 95.92 (16.07) 97.22 (12.92) 97.44 (15.11) 106.08 (10.40) 86.00 (25.65) 102.75 (10.38) 89.63 (17.00) 99.08 (15.60) g = 0.11
Note.EQ-VAS = EuroQol–5 Dimensions visual analog scale; High EQ-VAS =EuroQol–5 Dimensions visual analog scale≧50; Low EQ-VAS =EuroQol–5 Dimensions visual analog scale < 50; MMSE = Mini Mental State Examination; SD = standard deviation; Effect size g = Hedges' g Effect size of disease calculated Cramer's V which is a measure of association between two nominal variables (disease: cerebrospinal and musculoskeletal disease, group: experiment and control group).
Experimental Group Control Group
Total (n = 36)
Total (n = 36)
Effect Size Age, Mean (SD)
Sex, n
Flow state scale for Occupational task, Mean (SD)
Functional Independence Measure, Mean (SD)
V = 0.06 V = 0.09
T a b l e 3 . A ct i v i t i e s t a rg e t e d b y t he e x p e ri m e nt a l a nd co nt ro l g ro up s
T he a ct i v i t y wa s s e l e ct e d b y t h e cl i e nt a nd t h e t he ra p i s t us i ng t he C a na d i a n O cc up a t i o na l P e rf o rm a nce Me a s u re . T he t a b l e s ho ws t he t o t a l n um b e r o f a ct i v i t i e s s e l e ct e d . T he t o t a l n um b e r
o f a ct i v i t i e s s e l e ct e d i n t h e t wo g ro up s wa s s i m i l a r .
T a b l e 4 . T he p r e - , p o s t - , a nd f o l l o w - up a s s e s s m e nt s co re s a nd t h e cha ng e s i n t he s co re s o f I k i g a i - 9 , E Q - 5 D- 5 L , F l o w S t a t e S ca l e f o r O cc up a t i o na l T a s k, a nd F u n ct i o na l I nd e p e nd e n ce M e a s ure
A m o ng t h e t wo g ro up s , t h e e f f e ct s i z e o f cha ng e d s co re s ( p r e – p o s t - a s s e s s m e nt ) f o r I ki g a i - 9 a nd E Q - 5 D- 5 L wa s m o d e ra t e , whe re a s t h e e f f e ct s i z e o f F l o w S t a t e S ca l e f o r Oc cup a t i o na l
T a s k a nd F u nct i o na l I nd e p e nd e n ce Me a s ure wa s s m a l l e r.
Outcome n Mean SD n Mean SD Hedge's g lower upper
Ikigia-9
Pre 36 28.00 6.88 36 29.17 9.06
Post 35 32.14 6.31 36 28.89 7.85
Follow-up 29 29.83 7.10 31 28.10 7.75
Change score (pre-post) 35 4.06 6.58 36 -0.28 4.63 0.76 0.27 1.24
Change score (pre-follow) 29 1.97 6.84 31 -1.61 6.55 0.53 0.01 1.04
EQ-5D-5L
Pre 36 0.50 0.24 36 0.58 0.23
Post 35 0.74 0.15 36 0.69 0.16
Follow-up 28 0.66 0.20 29 0.65 0.14
Change score (pre-post) 35 0.24 0.23 36 0.11 0.20 0.62 0.14 1.10
Change score (pre-follow) 28 0.16 0.26 29 0.10 0.22 0.28 -0.25 0.80
Flow State Scale for Occupational Task
Pre 36 79.56 10.90 36 75.47 15.32
Post 35 81.09 10.54 36 78.11 14.15
Change score 35 1.66 10.15 36 2.64 10.33 -0.09 -0.56 0.37
Functional Independence Measure
Pre 36 97.44 15.11 36 99.08 15.60
Post 35 119.80 5.50 36 118.14 6.97
Change score 35 22.57 13.67 36 19.06 13.75 0.25 -0.21 0.72
EQ-5D-5L = EuroQol–5 Dimensions; SD = standard deviation.
Experimental group Control group Effect size between groups
Note. Pre = At admission to the recovery rehabilitation unit; Post = At discharge; Follow = At 3 months after discharge;
