Functionality and Quality of Life with Parkinson’s Disease after Use of a Dynamic Upper Limb Orthosis: A Pilot Study

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