Ci a ion: Jiménez-Ba ios, M.;
González-Be nal, J.; Cubo, E.;
Gab iel-Galán, J.M.; Ga cía-López, B.;
Be a di, A.; To ani, M.; Galeo o, G.;
Ma hews, M.J.A.; San ama ía-Peláez,
M.; e al. Func ionali y and Quali y o
Li e wi h Pa kinson’s Disease a e
Use o a Dynamic Uppe Limb
O hosis: A Pilo S udy. In . J.
En i on. Res. Public Heal h 2023,20,
4995. h ps://doi.o g/10.3390/
ije ph20064995
Academic Edi o : Al onsina D’Io io
Recei ed: 20 No embe 2022
Re ised: 4 Ma ch 2023
Accep ed: 7 Ma ch 2023
Published: 12 Ma ch 2023
Copy igh : © 2023 by he au ho s.
Licensee MDPI, Basel, Swi ze land.
This a icle is an open access a icle
dis ibu ed unde he e ms and
condi ions o he C ea i e Commons
A ibu ion (CC BY) license (h ps://
c ea i ecommons.o g/licenses/by/
4.0/).
In e na ional Jou nal o
En i onmen al Resea ch
and Public Heal h
A icle
Func ionali y and Quali y o Li e wi h Pa kinson’s Disease a e
Use o a Dynamic Uppe Limb O hosis: A Pilo S udy
Ma ía Jiménez-Ba ios 1, Je ónimo González-Be nal 1,* , Es he Cubo 2, JoséMa ía Gab iel-Galán2,
Bea iz Ga cía-López 3, Anna Be a di 4, Ma co To ani 4, Gio anni Galeo o 4, Ma in J. A. Ma hews 5,
Mi ian San ama ía-Peláez 1and Jose a González-San os 1
1Depa men o Heal h Sciences, Uni e si y o Bu gos, 09001 Bu gos, Spain
2Neu ology Se ice, Bu gos Uni e si y Hospi al, 09006 Bu gos, Spain
3Neu ophysiology Se ice, Bu gos Uni e si y Hospi al, 09006 Bu gos, Spain
4Depa men o Human Neu osciences, Uni e si y o la Sapienza, 00188 Rome, I aly
5Facul y o Heal h, School o Heal h P o essions Peninsula Allied Heal h Cen e, Uni e si y o Plymou h,
De i o d Rd., Plymou h PL6 8BH, UK
*Co espondence: [email p o ec ed]; Tel.: +34-606363553
Abs ac :
Pa kinson’s disease (PD) is a ch onic, neu odegene a i e mo emen diso de , whose
symp oms ha e a nega i e impac on quali y o li e and unc ionali y. Al hough i s main ea men is
pha macological, non-pha macological aids such as he dynamic elas ome ic ab ic o hosis (DEFO)
me i an e alua ion. Ou objec i e is o assess he DEFO in uppe limb (UL) unc ional mobili y and
in he quali y o li e o PD pa ien s. A o al o 40 pa ien s wi h PD pa icipa ed in a andomized
con olled c osso e s udy, and we e assigned o a con ol g oup (CG) and o an expe imen al g oup
(EG). Bo h g oups used he DEFO o wo mon hs, he expe imen al g oup he i s wo mon hs o
he s udy and he con ol g oup he las wo. Mo o a iables we e measu ed in he ON and OFF
s a es a he baseline assessmen and a wo mon hs. Di e ences om he baseline assessmen we e
obse ed in some mo o i ems o he Kinesia assessmen , such as es emo , ampli ude, hy hm o
al e na ing mo emen s in he ON and OFF s a es wi h and wi hou o hosis. No di e ences we e
ound in he uni ied Pa kinson’s disease a ing scale (UPDRS) o he PD quali y-o -li e ques ionnai e.
The DEFO imp o es some mo o aspec s o he UL in PD pa ien s bu his does no ansla e o he
amelio a ion o he s anda d o unc ional and quali y-o -li e scales.
Keywo ds:
Pa kinson’s disease; dynamic elas ome ic ab ic o hosis; unc ionali y; quali y o li e;
non-pha macological ea men
1. In oduc ion
In he Global Bu den o Diseases, Inju ies and Risk Fac o s (GBD) s udy conduc ed in
2016, i was es ima ed ha be ween he yea s 1990 and 2016 he numbe o people a ec ed
by Pa kinson’s disease (PD) doubled wo ldwide, wi h an incidence a e o 8 o 18 people
pe 100,000 pe yea [
1
]. PD is de ined as a ch onic, neu odegene a i e mo emen diso de ,
whose mos cha ac e is ic mo o symp oms a e es ing emo , igidi y, and b adykinesia.
Res ing emo is cha ac e ized by a p ominen in olun a y, hy hmic muscle mo emen
in he dis al uppe limb (UL) a a equency o abou 4 o 6 Hz. Rigidi y is an inc eased
esis ance o passi e mo emen . The hi d mos cha ac e is ic symp om is b adykinesia,
cha ac e ized by slow mo emen and di icul y planning, ini ia ing, and ca ying ou a
mo emen [
2
]. O he non-mo o symp oms such as sleep p oblems, cons ipa ion, anxie y,
dep ession and a igue may also appea [3]
The mo o and non-mo o symp oms o PD ha e nega i e epe cussions on he quali y
o li e and unc ionali y o people wi h he disease. The bu den o mo o symp oms
and impai men o some ac i i ies o daily li ing (ADLs), such as ea ing, hygiene and
In . J. En i on. Res. Public Heal h 2023,20, 4995. h ps://doi.o g/10.3390/ije ph20064995 h ps://www.mdpi.com/jou nal/ije ph
In . J. En i on. Res. Public Heal h 2023,20, 4995 2 o 12
clo hing, ela ed o al e a ions in unc ional mobili y, has been iden i ied as one o he majo
p edic o s o quali y o li e wi h his disease [4–6].
Following he pe spec i e o he In e na ional Classi ica ion o Func ioning and Dis-
abili y (ICF) o he Wo ld Heal h O ganiza ion (WHO), h ee in e connec ed le els o
human unc ioning a e di e en ia ed: (1) Body unc ions and s uc u es, physiological
and psychological unc ions, and bodily and ana omical impai men s; (2) Limi a ions in
he pe o mance o ac i i ies; and (3) Res ic ions in pa icipa ion in daily li e [
7
,
8
]. The
p og ession o PD leads o al e a ions in body unc ion, limi ed pe o mance o ADLs and
inc eased dependence, while educing quali y o li e [4,8–10].
As he disease p og esses, he wo sening o symp oms, such as emo , igidi y and
b adykinesia, leads o a de e io a ion o manual dex e i y, which ansla es o a g ea e
di icul y in pe o ming some ADLs. The mos commonly epo ed basic sel -ca e ac i i ies
a ec ed by PD symp oms a e ba hing/showe ing, d essing, and g ooming/pe sonal hy-
giene. O he ins umen al ac i i ies o daily li ing ha a e a ec ed a e d i ing, p epa ing
ood, shopping, and w i ing [
11
]. The e o e, he p esence o hese symp oms is closely
ela ed o a poo e quali y o li e [5,12].
The ea men o PD is mainly based on he adminis a ion o le odopa, whose e icacy
dec eases o e ime and can p oduce side e ec s such as mo o luc ua ions, dyskinesias
and dopamine gic dys egula ion synd ome. The onse o he disease and he a ie y o
possible symp oms makes i di icul o design a he apeu ic egimen o he ea men o
he disease. So a , app o ed he apies ha e ocused on compensa o y app oaches aimed
a ea ing clinical symp oms. Howe e , he cu en esea ch is ocused on delaying o
hal ing disease p og ession and no only on empo a y symp oma ic elie . Cu en ly, all
he apies a e di ec ed owa d amelio a ing mo o de ici s by inc easing dopamine, bu
un o una ely, his loses e icacy o e ime as dopamine gic neu odegene a ion p og esses,
wi h symp oms wo sening in he long- e m. The e o e, new non-pha macological he apies
need o be assessed [13–15].
The e a e se e al non-pha macological he apies design o educe unc ional impai -
men s o his disease and, al hough e idence o hei e icacy is inc easing, he e is s ill a
limi ed numbe o s udies on hem and on he necessa y in e en ion doses [
16
,
17
]. New
non-pha macological he apies ha can be easily implemen ed can complemen pha ma-
cological ea men in o de o imp o e he pa ien s’ unc ional mobili y and quali y o li e.
In his ega d, he dynamic elas ome ic ab ic o hoses (DEFO, Figu e 1) may be a sui able
candida e o educing mo o symp oms and imp o ing unc ional mo emen and quali y
o li e in pa ien s wi h PD. These ypes o de ices we e de eloped by dynamic mo emen
o hoses®, led by clinical o hopedis and managing di ec o Ma in Ma hews. They a e
cus om-designed de ices o he use ’s limbs o o he pa s o his/he body. Th ough
he applica ion o ac ion o ces, hey b ing he limb in o a be e biomechanical align-
men , while allowing and guiding mo emen . The elas ic ab ic p omo es he ex ension
o inge s and w is , he s abili y o he humb and he supina ion o p ona ion o he
o ea m. In addi ion, due o he localized comp ession o he so issues and he s imula-
ion o he de mal and p op iocep i e ecep o s, i is possible o egula e mo o ac i i y,
a oiding a ophy and muscle igidi y, imp o ing he pa ien ’s quali y o li e [
18
,
19
]. These
o hoses, compa ed o o he o hopedic de ices, ha e demons a ed be e ole ance and
high use sa is ac ion [20–22].
This ype o de ice has been e ec i e in child en wi h ce eb al palsy (CP). In he s udy
conduc ed by Pa ão e al., he use, by child en wi h CP, o a es made o his ma e ial
showed be e pos u al s abili y when pe o ming a manual eaching ac i i y [
23
], and in
ano he s udy, i showed imp o ed balance, pos u al con ol, and manual dex e i y [
24
].
On he o he hand, wea ing hese de ices on he oo and ankle imp o ed balance and
walking speed in mul iple scle osis [
25
,
26
], and pain and unc ion in pa ien s su e ing wi h
complex egional pain synd ome (CRPS) [
16
]. S oke has been he condi ion in which he
use o his UL o hosis has been mos in es iga ed, and se e al s udies ha e shown posi i e
In . J. En i on. Res. Public Heal h 2023,20, 4995 3 o 12
e ec s on s eng h, manual dex e i y, and UL unc ionali y, which need o be con i med in
s udies wi h la ge sample sizes [27,28].
In . J. En i on. Res. Public Heal h 2023, 20, x FOR PEER REVIEW 3 o 12
Figu e 1. DEFO implemen ed in a pa ien wi h PD.
This ype o de ice has been e ec i e in child en wi h ce eb al palsy (CP). In he
s udy conduc ed by Pa ão e al., he use, by child en wi h CP, o a es made o his ma-
e ial showed be e pos u al s abili y when pe o ming a manual eaching ac i i y [23],
and in ano he s udy, i showed imp o ed balance, pos u al con ol, and manual dex e i y
[24]. On he o he hand, wea ing hese de ices on he oo and ankle imp o ed balance
and walking speed in mul iple scle osis [25,26], and pain and unc ion in pa ien s su e -
ing wi h complex egional pain synd ome (CRPS) [16]. S oke has been he condi ion in
which he use o his UL o hosis has been mos in es iga ed, and se e al s udies ha e
shown posi i e e ec s on s eng h, manual dex e i y, and UL unc ionali y, which need
o be con i med in s udies wi h la ge sample sizes [27,28].
DEFOs ha e no ye been in es iga ed in in a wide ange o mo o a iables in PD.
In he ecen e iew, conduc ed by Son Nguyen, s udies o di e en ypes o po able o -
hoses o UL emo supp ession we e assessed, he majo i y being ac i e o hoses (45%),
ollowed by semi-ac i e o hoses (35%), and passi e o hoses (20%). All o hoses ha e
p o en o be e ec i e in supp essing emo s, bu se e al had incon eniencies such as
being hea y and bulky, had no been e alua ed in labo a o y se ings o we e no ye
comme cially a ailable [29].
Al hough cu en o hoses ha e p o en o be e ec i e in supp essing emo , hei
clinical o home use is s ill limi ed. This limi ed hei clinical o home use o supp essing
emo . Gi en hese o me esul s and lack o s udies in PD, ou main objec i e was o
analyze he e icacy o a ligh e de ice o he UL, such as he DEFO, in mo o a iables,
unc ional mobili y and quali y o li e in PD.
2. Ma e ials and Me hods
2.1. Pa icipan s
A longi udinal c osso e s udy, wi h a con ol g oup and an expe imen al g oup,
was ca ied ou . Pa icipan s wi h PD we e ec ui ed by consecu i e non-p obabili y sam-
pling om Sep embe o Oc obe 2021. The inclusion c i e ia we e: male and emale pa-
ien s diagnosed wi h PD, who, du ing he ec ui men pe iod, we e a ending he Neu-
ology Depa men o he Bu gos Uni e si y Hospi al, in any o he s ages o se e i y o
he disease, who had emo and igidi y as a consequence o he disease in a leas one o
he UL. Pa ien s whose emo was a consequence o ano he associa ed disease acco ding
o he neu ologis ’s judgmen o /and hose wi h sco es less han o equal o 26 on he
Mon eal cogni i e assessmen (MoCA) we e excluded [30].
The diagnosis o PD was es ablished ollowing he c i e ia es ablished by he In e -
na ional Pa kinson and Mo emen Diso de Socie y. The p e equisi e o he applica ion
o hese c i e ia is he p esence o b adykinesia in combina ion wi h es ing emo , igid-
i y o bo h. In addi ion, a leas wo o he ou suppo ing c i e ia had o be me : es ing
emo , d ama ic imp o emen wi h dopamine gic he apy, occu ence o dyskinesias as
Figu e 1. DEFO implemen ed in a pa ien wi h PD.
DEFOs ha e no ye been in es iga ed in in a wide ange o mo o a iables in PD.
In he ecen e iew, conduc ed by Son Nguyen, s udies o di e en ypes o po able
o hoses o UL emo supp ession we e assessed, he majo i y being ac i e o hoses (45%),
ollowed by semi-ac i e o hoses (35%), and passi e o hoses (20%). All o hoses ha e
p o en o be e ec i e in supp essing emo s, bu se e al had incon eniencies such as
being hea y and bulky, had no been e alua ed in labo a o y se ings o we e no ye
comme cially a ailable [29].
Al hough cu en o hoses ha e p o en o be e ec i e in supp essing emo , hei
clinical o home use is s ill limi ed. This limi ed hei clinical o home use o supp essing
emo . Gi en hese o me esul s and lack o s udies in PD, ou main objec i e was o
analyze he e icacy o a ligh e de ice o he UL, such as he DEFO, in mo o a iables,
unc ional mobili y and quali y o li e in PD.
2. Ma e ials and Me hods
2.1. Pa icipan s
A longi udinal c osso e s udy, wi h a con ol g oup and an expe imen al g oup, was
ca ied ou . Pa icipan s wi h PD we e ec ui ed by consecu i e non-p obabili y sampling
om Sep embe o Oc obe 2021. The inclusion c i e ia we e: male and emale pa ien s
diagnosed wi h PD, who, du ing he ec ui men pe iod, we e a ending he Neu ology
Depa men o he Bu gos Uni e si y Hospi al, in any o he s ages o se e i y o he
disease, who had emo and igidi y as a consequence o he disease in a leas one o
he UL. Pa ien s whose emo was a consequence o ano he associa ed disease acco ding
o he neu ologis ’s judgmen o /and hose wi h sco es less han o equal o 26 on he
Mon eal cogni i e assessmen (MoCA) we e excluded [30].
The diagnosis o PD was es ablished ollowing he c i e ia es ablished by he In e na-
ional Pa kinson and Mo emen Diso de Socie y. The p e equisi e o he applica ion o
hese c i e ia is he p esence o b adykinesia in combina ion wi h es ing emo , igidi y
o bo h. In addi ion, a leas wo o he ou suppo ing c i e ia had o be me : es ing
emo , d ama ic imp o emen wi h dopamine gic he apy, occu ence o dyskinesias
as a consequence o le odopa o ol ac o y loss, o ca diac sympa he ic dene a ion on
myoca dial scin ig aphy [31,32].
Each pa icipan signed a w i en in o med consen app o ed by he Clinical Resea ch
E hics Commi ee o he Heal h A ea o Bu gos and So ia (Spain) wi h e e ence numbe
CEIM-2119/2019 be o e pa icipa ing in he p esen s udy (ClinicalT ials.go es numbe :
In . J. En i on. Res. Public Heal h 2023,20, 4995 4 o 12
NCT04815382). Likewise, he s udy was conduc ed in acco dance wi h he e hical p inciples
se o h in he Decla a ion o Helsinki [33].
2.2. P ocedu es
The calcula ion o he sample size was based on he emo and igidi y imp o emen
as he main a iables o he s udy. Gi en alpha isk o 0.05 and a be a isk o 0.20, in
bila e al con as , i is es ima ed ha 40 pa icipan s (20 o each g oup) we e equi ed o
de ec a minimum di e ence o 0.50 in he igidi y and emo sco es o he mos a ec ed
UL using he uni ied Pa kinson’s disease a ing scale, mo o subscale pa III (UPDRS) [
34
].
Conside ing he 10% d opou a e du ing ollow-up, a o al sample o 40 pa ien s was
deemed necessa y.
Using he Epida 4.2 p og am, pa icipan s we e andomly assigned o he expe i-
men al g oup (EG) o he con ol g oup (CG). The EG ea men p o ocol consis ed o
implemen ing he DEFO in he mos a ec ed UL o wo mon hs (in e en ion pe iod),
whe eas subjec s in he CG led li e as usual du ing he i s wo mon hs (con ol pe iod).
One mon h p io o he implemen a ion o he DEFO, measu emen s o he size and pos u e
o he UL we e conduc ed o he cus omiza ion o he o hosis in he pa icipan s o bo h
g oups. A he i s isi , he sociodemog aphic and clinical da a o he pa icipan s we e
collec ed, and hei ul ilmen o he inclusion c i e ia was ensu ed. The pa icipan s we e
ins uc ed o main ain hei p esc ibed dopamine gic medica ion egimen. The e ec s o
he DEFO we e e alua ed du ing he ON s a e (unde he bene i o le odopa) and du ing
he OFF s a e (1 h be o e he nex le odopa in ake).
Mo o assessmen s we e conduc ed in he EG, a he end o he DEFO implemen a ion
pe iod. Then, he DEFO was wi hd awn and a second assessmen was conduc ed
wo mon hs
la e o e alua e i a ca y-o e e ec was main ained du ing ha ime (Figu e 2).
In . J. En i on. Res. Public Heal h 2023, 20, x FOR PEER REVIEW 4 o 12
a consequence o le odopa o ol ac o y loss, o ca diac sympa he ic dene a ion on myo-
ca dial scin ig aphy [31,32].
Each pa icipan signed a w i en in o med consen app o ed by he Clinical Re-
sea ch E hics Commi ee o he Heal h A ea o Bu gos and So ia (Spain) wi h e e ence
numbe CEIM-2119/2019 be o e pa icipa ing in he p esen s udy (ClinicalT ials.go es
numbe : NCT04815382). Likewise, he s udy was conduc ed in acco dance wi h he e hical
p inciples se o h in he Decla a ion o Helsinki [33].
2.2. P ocedu es
The calcula ion o he sample size was based on he emo and igidi y imp o emen
as he main a iables o he s udy. Gi en alpha isk o 0.05 and a be a isk o 0.20, in bila -
e al con as , i is es ima ed ha 40 pa icipan s (20 o each g oup) we e equi ed o de ec
a minimum di e ence o 0.50 in he igidi y and emo sco es o he mos a ec ed UL
using he uni ied Pa kinson’s disease a ing scale, mo o subscale pa III (UPDRS) [34].
Conside ing he 10% d opou a e du ing ollow-up, a o al sample o 40 pa ien s was
deemed necessa y.
Using he Epida 4.2 p og am, pa icipan s we e andomly assigned o he expe i-
men al g oup (EG) o he con ol g oup (CG). The EG ea men p o ocol consis ed o im-
plemen ing he DEFO in he mos a ec ed UL o wo mon hs (in e en ion pe iod),
whe eas subjec s in he CG led li e as usual du ing he i s wo mon hs (con ol pe iod).
One mon h p io o he implemen a ion o he DEFO, measu emen s o he size and pos-
u e o he UL we e conduc ed o he cus omiza ion o he o hosis in he pa icipan s o
bo h g oups. A he i s isi , he sociodemog aphic and clinical da a o he pa icipan s
we e collec ed, and hei ul ilmen o he inclusion c i e ia was ensu ed. The pa icipan s
we e ins uc ed o main ain hei p esc ibed dopamine gic medica ion egimen. The e -
ec s o he DEFO we e e alua ed du ing he ON s a e (unde he bene i o le odopa) and
du ing he OFF s a e (1 h be o e he nex le odopa in ake).
Mo o assessmen s we e conduc ed in he EG, a he end o he DEFO implemen a-
ion pe iod. Then, he DEFO was wi hd awn and a second assessmen was conduc ed wo
mon hs la e o e alua e i a ca y-o e e ec was main ained du ing ha ime (Figu e 2).
Figu e 2. S udy low cha . DEFO: dynamic elas ome ic ab ic o hoses.
Figu e 2. S udy low cha . DEFO: dynamic elas ome ic ab ic o hoses.
Se e al assessmen ools we e adminis e ed o e alua e he unc ional ac i i y, quali y
o li e, and manual dex e i y o he subjec s.
To ob ain he p ima y ou comes, he uni ied Pa kinson’s disease a ing scale subscale
II (UPDRS) was adminis e ed o assess unc ional ac i i y consis ing o 13 i ems. The sco e
o each i em is om 0 (no mal) o 4 (wo s ), wi h a maximum sco e o 52 poin s, whe e
highe sco es indica e wo se unc ional ac i i y [
35
–
37
]. To assess he quali y o li e o each
pa icipan , he 39-i em Pa kinson’s disease ques ionnai e (PDQ-39) was adminis e ed,
In . J. En i on. Res. Public Heal h 2023,20, 4995 5 o 12
which consis s o 29 i ems g ouped in o 8 domains: mobili y, ac i i ies o daily li ing,
emo ional well-being, s igma, social suppo , cogni ion, communica ion, and g ie and
dis ess. Pa icipan s ha e o answe he ques ions based on hei expe ience in he las
ou weeks. Each i em is sco ed om 0 (ne e ) o 4 (always). The maximum possible sco e
is 156, wi h highe sco es co esponding o wo se quali y o li e [38,39].
Fo he assessmen o UL dex e i y, di e en mo o aspec s we e e alua ed. Subscale
III o he UPDRS was adminis e ed, consis ing o 17 i ems wi h a sco e ange om 0 o
4 ( om
no mal symp oma ology o he mos se e e impai men ), wi h a maximum sco e
o 68 [
35
–
37
]. The Kinesia ONE mo o assessmen was used o collec and quan i y he
se e i y o mo o symp oms such as emo , b adykinesia, and dyskinesia. I p o ides an
objec i e moni o ing o Subscale III o he UPDRS. I is an elec onic de ice consis ing o
so wa e and a mo ion senso . This senso is posi ioned on he second inge o he hand
du ing he ime he pa ien pe o ms a p o ocol o 12 asks. The so wa e sco es each i em
om 0 (no symp oms) o 4 (se e e impai men ) [40].
Finally, he Pu due boa d es (PPT), he Minneso a manual dex e i y es (MMDT)
and he squa es es (ST) we e used o assess manual dex e i y. The PPT consis s o a
wo-column boa d ha includes o 25 holes each, oge he wi h pins, washe s, and ings
loca ed in ou semici cles a he op o he boa d. The es is composed o ou sub es s
ha mus be pe o med a o al o h ee imes, so ha he o al sco e is he a e age sco e
ob ained om he h ee a emp s a each sub es . Thus, highe sco es indica e be e manual
dex e i y [
41
,
42
]. T, he abb e ia ed e sion o he MMDT, con ains a ec angula wooden
boa d ha includes 60 holes dis ibu ed in 15 columns and 4 ows, as well as 60 ci cula
pieces wi h one black and one ed side o he same dimension as he holes in he boa d. I
consis s o wo sub es s ha a e pe o med a o al o 4 imes, ob aining as he inal sco e, he
a e age o he ou a emp s o each es . The inal sco e is he ime spen in pe o ming he
es , so he longe a pa ien spends, he wo se he pa ien ’s manual dex e i y [
43
]. Finally,
he ST con ains a shee o pape wi h ou g ids p in ed wi h 6 mm long squa es. In he
p ac ice es , he pa ien mus d aw as many squa es as possible o 10 s, while o he eal
es , he/she will ha e 30 s. The sco e is ob ained o each hand by adding he numbe o
do s d awn inside he squa es, wi hou ouching he edges. Thus, a highe numbe o do s
d awn indica es a be e manual dex e i y [44] (Figu e 3).
In . J. En i on. Res. Public Heal h 2023, 20, x FOR PEER REVIEW 5 o 12
Se e al assessmen ools we e adminis e ed o e alua e he unc ional ac i i y, qual-
i y o li e, and manual dex e i y o he subjec s.
To ob ain he p ima y ou comes, he uni ied Pa kinson’s disease a ing scale subscale
II (UPDRS) was adminis e ed o assess unc ional ac i i y consis ing o 13 i ems. The sco e
o each i em is om 0 (no mal) o 4 (wo s ), wi h a maximum sco e o 52 poin s, whe e
highe sco es indica e wo se unc ional ac i i y [35–37]. To assess he quali y o li e o each
pa icipan , he 39-i em Pa kinson’s disease ques ionnai e (PDQ-39) was adminis e ed,
which consis s o 29 i ems g ouped in o 8 domains: mobili y, ac i i ies o daily li ing,
emo ional well-being, s igma, social suppo , cogni ion, communica ion, and g ie and
dis ess. Pa icipan s ha e o answe he ques ions based on hei expe ience in he las
ou weeks. Each i em is sco ed om 0 (ne e ) o 4 (always). The maximum possible sco e
is 156, wi h highe sco es co esponding o wo se quali y o li e [38,39].
Fo he assessmen o UL dex e i y, di e en mo o aspec s we e e alua ed. Subscale
III o he UPDRS was adminis e ed, consis ing o 17 i ems wi h a sco e ange om 0 o 4
( om no mal symp oma ology o he mos se e e impai men ), wi h a maximum sco e o
68 [35–37]. The Kinesia ONE mo o assessmen was used o collec and quan i y he se-
e i y o mo o symp oms such as emo , b adykinesia, and dyskinesia. I p o ides an
objec i e moni o ing o Subscale III o he UPDRS. I is an elec onic de ice consis ing o
so wa e and a mo ion senso . This senso is posi ioned on he second inge o he hand
du ing he ime he pa ien pe o ms a p o ocol o 12 asks. The so wa e sco es each i em
om 0 (no symp oms) o 4 (se e e impai men ) [40].
Finally, he Pu due boa d es (PPT), he Minneso a manual dex e i y es (MMDT)
and he squa es es (ST) we e used o assess manual dex e i y. The PPT consis s o a wo-
column boa d ha includes o 25 holes each, oge he wi h pins, washe s, and ings lo-
ca ed in ou semici cles a he op o he boa d. The es is composed o ou sub es s ha
mus be pe o med a o al o h ee imes, so ha he o al sco e is he a e age sco e ob-
ained om he h ee a emp s a each sub es . Thus, highe sco es indica e be e manual
dex e i y [41,42]. T, he abb e ia ed e sion o he MMDT, con ains a ec angula wooden
boa d ha includes 60 holes dis ibu ed in 15 columns and 4 ows, as well as 60 ci cula
pieces wi h one black and one ed side o he same dimension as he holes in he boa d. I
consis s o wo sub es s ha a e pe o med a o al o 4 imes, ob aining as he inal sco e,
he a e age o he ou a emp s o each es . The inal sco e is he ime spen in pe o ming
he es , so he longe a pa ien spends, he wo se he pa ien ’s manual dex e i y [43]. Fi-
nally, he ST con ains a shee o pape wi h ou g ids p in ed wi h 6 mm long squa es. In
he p ac ice es , he pa ien mus d aw as many squa es as possible o 10 s, while o he
eal es , he/she will ha e 30 s. The sco e is ob ained o each hand by adding he numbe
o do s d awn inside he squa es, wi hou ouching he edges. Thus, a highe numbe o
do s d awn indica es a be e manual dex e i y [44] (Figu e 3).
Figu e 3. E alua ion ki (Pu due pegboa d, Minneso a and Kinesia ONE).

In . J. En i on. Res. Public Heal h 2023,20, 4995 6 o 12
3. Resul s
3.1. Baseline Cha ac e is ics o he S udy Pa icipan s
The s udy had a simple c osso e design, a o al sample o 40 people wi h PD,
20 assigned o he CG, and 20 o he EG.
Table 1summa izes he baseline socio-demog aphic cha ac e is ics o he pa icipan s
acco ding o he s udy g oup. Men ep esen ed 75% o he pa icipan s (n= 30), aged
be ween 48 and 89 yea s, wi h a mean age o 71.00
±
9.20 yea s and wi h 5.38
±
4.23 yea s
o disease e olu ion. The majo i y o pa icipan s (n= 35, 87.5%) li ed accompanied a
home, a mino i y li ed alone a home (n= 4, 10%), and one in a eligious communi y.
Table 1. Baseline cha ac e is ics o pa icipan s.
Va iables To al (n= 40) CG (n= 20) EG (n= 20)
Age (yea s) 71.00 ±9.20 69.55 ±12.31 72.18 ±5.58
Gende
Male 30 15 15
Female 10 3 7
Mos a ec ed UL
Righ 25 14 11
Le 15 3 12
Yea s o disease e olu ion 5.38 ±4.23 4.72 ±3.86 5.91 ±4.52
Cu en non-pha macological ea men
Physio he apy 2 0 2
Occupa ional he apy 0 0 0
Speech he apy 1 1 0
All 1 1 0
None 35 15 20
O he s 1 1 0
Abb e ia ions: CG: con ol g oup; EG: expe imen al g oup; UL: uppe limb.
O he pa icipan s, 62.5% (n= 25) had g ea e in ol emen in he igh UL, while
37,5% (n= 15) had g ea e in ol emen in he le UL. Mos pa icipan s (87.5%, n= 35) did
no ecei e any ype o non-pha macological ea men and he es , 12.5% (n= 5), a ended
physio he apy, speech he apy, and/o occupa ional he apy.
Table 2shows he Kinesia ONE
®
measu emen s o ac ion, es ing emo , and igidi y
o he CG and EG pa icipan s be o e s a ing he in e en ion. The only di e ences be ween
he g oups a e in es ing emo o he le UL in he OFF s a e.
Table 2. Baseline UPDRS sco es— es ing and ac ion emo sub es .
UPDRS III CG (n= 20) EG (n= 20) F p-Value
Ac ion emo ON
Righ UL 0.625 ±0.806 0.727 ±702 0.173 0.680
Le UL 0.625 ±0.619 0.863 ±0.639 1.324 0.257
Ac ion emo OFF
Righ UL 0.875 ±0.806 0.954 ±0.843 0.085 0.772
Le UL 0.750 ±0.577 1.181 ±0.795 3.403 0.073
Res emo OFF
Righ UL 0.625 ±0.619 1.136 ±1.082 2.874 0.099
Le UL 0.500 ±0.632 1.227 ±0.922 7.391 0.010
Res emo ON
Righ UL 0.375 ±0.619 0.818 ±0.906 2.845 0.100
Le UL 0.375 ±0.500 0.772 ±0.812 2.995 0.092
CG: con ol g oup; EG: expe imen al g oup; p- alue < 0.05.
In . J. En i on. Res. Public Heal h 2023,20, 4995 7 o 12
3.2. Func ionali y and Quali y o Li e
Table 3shows he di e ences obse ed in he baseline assessmen wi h and wi hou
o hosis in he OFF s a e in he mo o a iables e alua ed wi h Kinesia ONE
®
. Wea ing
he o hesis educes “pos u al emo ” compa ed wi h no wea ing i (p= 0.042), which
can imp o e unc ionali y and quali y o li e. The same e ec may educe he o hesis o
“ inge apping ampli ude” (p= 0.18) and o “speed in apid al e na ing mo emen s” wi h
o hosis (p< 0.001).
Table 3. Kinessia OFF s a e, wi h and wi hou o hoses—baseline assessmen (n= 40).
Va iables Mean SD p-Value
Res emo Wi hou o hoses 1.102 0.926 0.378
Wi h o hoses 0.956 0.900
Pos u al emo Wi hou o hoses 0.864 0.761
0.042
Wi h o hoses 0.621 0.631
Kine ic emo Wi hou o hoses 1.150 0.506
0.934
Wi h o hoses 1.136 0.952
Finge apping—speed Wi hou o hoses 1.888 1.012
0.834
Wi h o hoses 1.869 1.010
Finge apping—ampli ude Wi hou o hoses 2.302 0.921 0.018
Wi h o hoses 2.016 0.988
Finge apping— hy hm Wi hou o hoses 1.352 1.041
0.719
Wi h o hoses 1.302 0.983
Hand mo emen s—speed Wi hou o hoses 2.030 0.767
0.300
Wi h o hoses 2.119 0.699
Hand mo emen s—ampli ude Wi hou o hoses 1.400 0.767
0.948
Wi h o hoses 1.408 0.926
Hand mo emen s— hy m Wi hou o hoses 0.891 0.651
0.669
Wi h o hoses 0.850 0.683
Al e na ing quick mo emen s—speed Wi hou o hoses 2.348 0.774
<0.001
Wi h o hoses 1.317 0.744
Al e na ing quick mo emen s–ampli ude Wi hou o hoses 1.251 0.702
0.307
Wi h o hoses 1.317 0.744
Al e na ing quick mo emen s— hy m Wi hou o hoses 1.285 1.247
0.367
Wi h o hoses 1.117 1.005
Pai ed samples - es ; p- alue < 0.05. SD: s anda d de ia ion.
Table 4shows he di e ences in he mo o a iables e alua ed wi h Kinesia ONE
®
(Cle eland, OH, USA) in he baseline assessmen wi h and wi hou o hosis in he ON s a e.
Wea ing he o hosis educes “ es ing emo ” compa ed wi h no wea ing i (p= 0.009),
which can imp o e unc ionali y and quali y o li e. In he same way, he educ ion wi h
he o hosis o “ inge apping ampli ude” (p= 0.027) and in he i em “ampli ude o apid
al e na ing mo emen s” (p= 0.017) wi h o hosis can a o unc ionali y and quali y o li e.
In . J. En i on. Res. Public Heal h 2023,20, 4995 8 o 12
Table 4. Kinessia ON s a e, wi h and wi hou o hoses—baseline assessmen (n= 40).
Va iables Mean SD p-Value
Res emo Wi hou o hoses 0.997 0.830 0.009
Wi h o hoses 0.652 0.716
Pos u al emo Wi hou o hoses 0.832 0.877 0.432
Wi h o hoses 0.744 0.619
Kine ic emo Wi hou o hoses 1.184 0.421 0.416
Wi h o hoses 1.128 0.426
Finge apping—speed Wi hou o hoses 1.910 0.991 0.806
Wi h o hoses 1.878 1.018
Finge apping—Ampli ude Wi hou o hoses 2.273 0.932 0.027
Wi h o hoses 1.952 1.051
Finge apping— hy hm Wi hou o hoses 1.171 0.963 0.319
Wi h o hoses 0.997 0.795
Hand mo emen s—speed Wi hou o hoses 2.089 0.743 0.922
Wi h o hoses 2.097 0.672
Hand mo emen s—Ampli ude Wi hou o hoses 1.605 0.865 0.685
Wi h o hoses 1.542 0.899
Hand mo emen s— hy hm Wi hou o hoses 1.021 0.798 0.051
Wi h o hoses 0.085 0.589
Al e na ing quick mo emen s—speed Wi hou o hoses 2.278 0.720 0.198
Wi h o hoses 2.984 3.219
Al e na ing quick mo emen s—ampli ude
Wi hou o hoses 1.084 0.831 0.017
Wi h o hoses 1.265 0.696
Al e na ing quick mo emen s— hy hm Wi hou o hoses 1.294 1.319 0.479
Wi h o hoses 1.157 1.036
Pai ed samples - es ; p- alue < 0.05. SD: s anda d de ia ion.
When compa ing he change sco es ob ained on he UPDRS-II acco ding o he pa ien s’
condi ion and g oup ype, no s a is ically signi ican di e ences we e obse ed be ween he
ini ial assessmen and a e wo mon hs o o hosis implemen a ion in ei he he pa ien s’
ON o OFF s a e. This means ha no imp o emen in he UPDRS-II sco e was ob ained
a e DEFO (Table 5).
Table 5.
In e -g oup compa ison o UPDRS-II di e en ial sco e acco ding o he ype o g oup
using ANCOVA.
Va iables G oup Mean SD MS F p-Value ï2
OFF—wi h o hoses CG 0.000 0.000 40.267 1.629 0.208 0.033
EG −1.914 5.907
OFF—wi hou o hoses CG 0.500 7.033 87.233 2.546 0.117 0.048
EG −2.263 5.217
ON—wi h o hoses CG 0.000 0.000 31.762 1.430 0.238 0.029
EG −10.742 5.606
ON—wi hou o hoses CG 0.187 5.344 7.123 0.290 0.593 0.006
EG −0.631 4.732
CG: con ol g oup (n= 20); EG: expe imen al g oup (n= 20); SD: s anda d de ia ion, p- alue < 0.05.
In . J. En i on. Res. Public Heal h 2023,20, 4995 9 o 12
Likewise, no di e ences (p= 0.933) we e obse ed in he quali y o li e o he subjec s
a e he implemen a ion o he o hosis (Table 6).
Table 6. In e -g oup compa ison o PDQ-39 di e en ial sco e be ween p e- es and pos - es .
PDQ-39 nMean SD MS F p-Value ï2
CG 16 −0.625 6.830 0.441 0.007 0.933 0.000
EG 22 −0.818 8.313
CG con ol g oup (n= 20), EG: expe imen al g oup (n= 20), SD: s anda d de ia ion, p- alue < 0.05.
4. Discussion
The aim o his s udy was o analyze he e icacy o he use o a DEFO o he UL on
he unc ionali y and quali y o li e o people wi h PD. The main indings o he p esen
s udy a e an immedia e imp o emen a e he implemen a ion o he o hosis in he OFF
and ON s a es o mo o a iables in he pos u al emo ask; only in he OFF s a e in he
speed o apid al e na ing mo emen s and only in he ON s a e in he hy hm o hand
mo emen s and ampli ude o apid al e na ing mo emen s. No di e ences we e obse ed
a e wo mon hs o o hosis use in he imp o emen o unc ionali y o in he quali y o
li e o he pa ien wi h PD.
Neu ological diso de s, such as PD, a e cu en ly he leading sou ce o disabili y in
he wo ld. The global bu den o disease s udy es ima ed ha he numbe o people wi h
PD will double om abou 7 million in 2015 o app oxima ely 13 million in 2040. This
es ima ion o he g ow h o he popula ion wi h PD is wo ying conside ing he amoun o
bu den his disease ca ies o socie y [45].
The neu odegene a i e e ec s o PD lead o a loss o unc ional mobili y in balance,
pos u al s abili y and gai , dec easing independence in he pe o mance o ac i i ies,
and comp omising hei pa icipa ion bo h a home and in he communi y [
6
,
46
,
47
]. On
he o he hand, con ex ual ac o s such as age, he eeling o being a pe son wi h a dis-
abili y, unemploymen o pe cei ed con ol a e examples o pe sonal and en i onmen al
ac o s ha ha e a nega i e impac on he unc ional mobili y and quali y o li e o he
indi idual [6–8,47,48].
The e ha e been many ad ances in he knowledge o he e iopa hogenesis and in
he symp oma ic ea men o PD in ecen yea s. Howe e , he e a e no e ec i e neu-
op o ec i e o disease-modi ying he apies ha slow disease p og ession and imp o e
unc ionali y and quali y o li e wi hou p oducing side e ec s on he pa ien [5].
Due o he ac ha pha macological ea men loses i s e icacy wi h he passage
o ime and p oduces side e ec s in he pe son and he lack o p ecise knowledge abou
he cu en ly exis ing non-pha macological he apies, i is necessa y o implemen new
non-pha macological he apies ha allow an imp o emen in he unc ionali y and quali y
o li e o he pa ien [16,17].
All DEFOs a e made in he same way, being able o be designed and adap ed o
he needs o he pa hology and he use , so ha hey can be de ices o UL, lowe limbs
o es o he whole body. In diseases such as CP, di e en s udies ca ied ou wi h
es s and meshes o hese cha ac e is ics ha e demons a ed hei e icacy on pos u al
con ol, balance, walking speed, and manual dex e i y [
23
,
24
,
49
]. In he s udy conduc ed
by Yasukawa e al., in which DEFOs we e implemen ed o UL in wo cases wi h CP wi h
hemiplegia and b achial plexus palsy, imp o ed limb alignmen and imp o ed unc ionali y
o he a ec ed UL we e obse ed [
18
]. In he same way, hey ha e also been e ec i e in
imp o ing balance and walking speed in people wi h MS, as well as in imp o ing pain
and unc ionali y o he lowe limb in people wi h CRPS [
20
,
25
,
26
]. In a single case s udy
conduc ed by Wa son e al., he bene icial unc ional e ec s o a lyc a o hosis in a mul iple
scle osis pa ien we e equi ocal [
50
]. In ano he s udy o 16 pa ien s wi h hemipa esis
esul ing om b ain damage, he use o hese de ices showed a educ ion in muscle one
and swelling, and imp o ed w is and inge mo emen [
51
]. Al hough some s udies