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Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot) (RHB Home SNR)

23 juni 2026 uppdaterad av: Swiss Federal Institute of Technology

Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot): a Multicentric, Exploratory Study

The ReHandyBot (RHB) is a robot for hand rehabilitation after stroke. The aims of this study are to investigate (i) the generalizability of unsupervised therapy with the ReHandyBot within patients' home after discharge from a clinic, (ii) compliance, as measured by the amount of unsupervised robot-assisted therapy dose (e.g., therapy time) performed by the subjects after discharge, (iii) the usability of ReHandyBot and user experience during robot-assisted therapy, and (iv) the effect of the increase in therapy dose achieved with our device compared to standard care. The study consists of two primary phases. The first is a familiarization phase conducted at the clinic, where therapists teach participants how to perform the exercises using the robot. Then, if capable of training with the robot safely, after discharge from the clinic, participants can bring the robot home and autonomously train with it. The hypothesis is that unsupervised therapy might be a possible way to increase therapy dose for stroke patients, with the potential to further improve recovery of hand function, with minimal additional burden for therapists and for the healthcare system.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Informed Consent signed by the subject;
  • female and male patients between 18 and 90 years old;
  • acute/subacute stroke (recruitment within 12 weeks from stroke onset);
  • pre-stroke modified Rankin score ≤ 1;
  • National Institutes of Health Stroke Scale (NIHSS) ≥ 1 in at least one of the items regarding motor functions, sensory functions and ataxia;
  • possibility (e.g., enough space) to set up the ReHandyBot at home.

Exclusion Criteria:

  • modified Ashworth Scale > 2 for one or more of the following muscles: shoulder adductors, forearm pronator and supinator, flexors and extensors of elbow, wrist and fingers;
  • moderate to severe aphasia: Goodglass-Kaplan's scale < 3;
  • moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) < 9;
  • functional impairment of the upper limb due to other pathologies;
  • severe pain in the affected arm: visual analogue scale for pain (VASp) ≥ 5;
  • other pathologies which may interfere with the study;
  • after discharge the patient will go to an assisted living facility (e.g., care home).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Unsupervised therapy
This group will perform therapy with the ReHandyBot first with the supervision of a therapist at the rehabilitation clinic. Then, after discharge, if the participant has learned how to safely train with the device, they can bring the device home and train with it unsupervised.
Enhet: Supervised and minimally supervised therapy with ReHandyBot
During the familiarization phase at the rehabilitation clinics, participants perform one week of supervised and one week of minimally supervised therapy with the ReHandyBot under the supervision of a supervisor (i.e., therapist or researcher). Minimally supervised therapy means that participants try to perform therapy with the device themselves, while the supervisor is still present but helps only if participants encounter problems or have questions. During the supervised and minimally supervised phases (first 2 weeks), the intervention consists of 5 sessions of approximately 30 minutes each per week. These sessions are performed in addition to the conventional therapy plan. During each session, the robot proposes a set of different exercises targeting the upper limb.
Enhet: Unsupervised therapy
After the familiarization phase, participants train without supervision at the clinic until discharge and then at home for six weeks. If the therapist thinks that the participant has properly learned how to use the device and can train with it safely, the participant can keep training with the device unsupervised (both at the clinic and at home). If participants are not ready for unsupervised therapy with the device, they stop the study at the end of the familiarization phase.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dos av oövervakad terapi - minuter
Tidsram: Detta mäts under interventionen (dvs. under de sex veckorna av oövervakad behandling hemma).
Daglig dos i minuter av självadministrerad robotassisterad terapi utförd av försökspersoner i hemmiljö utan övervakning.
Detta mäts under interventionen (dvs. under de sex veckorna av oövervakad behandling hemma).
Dos av oövervakad terapi - Upprepningar
Tidsram: Detta mäts under interventionen (dvs. under de sex veckorna av oövervakad behandling hemma).
Daglig dos i antal uppgiftsrepetitioner av självadministrerad robotassisterad terapi utförd av försökspersoner i hemmiljö utan övervakning.
Detta mäts under interventionen (dvs. under de sex veckorna av oövervakad behandling hemma).
Dos av oövervakad terapi - Procentuell förändring av terapitiden
Tidsram: Detta mäts under interventionen (dvs. under de sex veckorna av oövervakad behandling hemma).
Procentuell ökning av terapitiden på grund av den oövervakade robotterapin jämfört med fallet där deltagarna endast skulle utföra konventionell (d.v.s. normalt ordinerad) terapi.
Detta mäts under interventionen (dvs. under de sex veckorna av oövervakad behandling hemma).

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Genomförbarhet - Biverkningar
Tidsram: Detta övervakas under hela protokollets varaktighet (d.v.s. från början av den första veckan till slutet av de sex veckorna av oövervakad behandling hemma).
Genomförbarheten av terapi med ReHandyBot bedömd av antalet biverkningar som inträffade under denna studie.
Detta övervakas under hela protokollets varaktighet (d.v.s. från början av den första veckan till slutet av de sex veckorna av oövervakad behandling hemma).
Genomförbarhet - Enhetsbrister
Tidsram: Detta övervakas under hela protokollets varaktighet (d.v.s. från början av den första veckan till slutet av de sex veckorna av oövervakad behandling hemma).
Genomförbarheten av terapi med ReHandyBot bedömd av antalet enhetsbrister som inträffade under denna studie.
Detta övervakas under hela protokollets varaktighet (d.v.s. från början av den första veckan till slutet av de sex veckorna av oövervakad behandling hemma).
Ändring i det aktiva rörelseomfånget (aROM) för grepp mätt i millimeter enligt den anpassade robotbedömningen "aROM - Hand"
Tidsram: Detta beräknas i slutet av studien, efter att de slutliga mätningarna har utförts (d.v.s. i slutet av de sex veckorna av oövervakad behandling hemma).
Byt mellan baslinjen (dvs. början av studien) och slutlig (dvs. slutet av studien) aROM för att greppa, dvs. för handöppning och stängning. Detta mäts av roboten med en anpassad bedömning.
Detta beräknas i slutet av studien, efter att de slutliga mätningarna har utförts (d.v.s. i slutet av de sex veckorna av oövervakad behandling hemma).
Förändring i haptisk uppfattning som bedöms av den anpassade robotbedömningen "Weber Fraction" som mäter den minsta skillnaden i stelhet som en patient kan uppfatta i procent
Tidsram: Detta beräknas i slutet av studien, efter att de slutliga mätningarna har utförts (d.v.s. i slutet av de sex veckorna av oövervakad behandling hemma).
Byt mellan baslinjen (dvs. början av studien) och slutlig (dvs. slutet av studien) haptisk perception, definierad som den minsta skillnaden i stelhet som en patient kan uppfatta uttryckt i procent enligt Weber Fraction-lagen. Detta mäts av roboten med en anpassad bedömning som heter "Weber fraktion".
Detta beräknas i slutet av studien, efter att de slutliga mätningarna har utförts (d.v.s. i slutet av de sex veckorna av oövervakad behandling hemma).
Innehåll i robotterapi - Prestation
Tidsram: Detta övervakas under hela protokollets varaktighet (d.v.s. från början av den första veckan till slutet av de sex veckorna av oövervakad behandling hemma).
Uppgiftsutförande (d.v.s. korrekta försök över totala försök) under robotterapi under hela studien.
Detta övervakas under hela protokollets varaktighet (d.v.s. från början av den första veckan till slutet av de sex veckorna av oövervakad behandling hemma).
Innehåll i robotterapi - Effektivt tidsförhållande
Tidsram: Detta övervakas under hela protokollets varaktighet (d.v.s. från början av den första veckan till slutet av de sex veckorna av oövervakad behandling hemma).
Förhållandet mellan effektiv (d.v.s. total nettoterapitid utan pauser) över total varaktighet av terapisessionen under robotterapi under hela studien.
Detta övervakas under hela protokollets varaktighet (d.v.s. från början av den första veckan till slutet av de sex veckorna av oövervakad behandling hemma).
Parametrar som påverkar oövervakad robotassisterad terapi
Tidsram: Detta beräknas i slutet av studien (dvs i slutet av de sex veckorna av oövervakad terapi hemma).
Korrelation mellan uppnådd oövervakad robotassisterad terapidos och olika parametrar (d.v.s. kognitiva bedömningar (Goodglass-Kaplan Scale, LCF-R, Montreal Cognitive Assessment (MoCA)) som utfördes under screeningbesöket, de kliniska bedömningarna, robotbedömningarna, demografi och de insamlade medicinska uppgifterna).
Detta beräknas i slutet av studien (dvs i slutet av de sex veckorna av oövervakad terapi hemma).
Feasibility - Subjects performing unsupervised robot-assisted training
Tidsram: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
Feasibility of unsupervised therapy with the ReHandyBot as assessed by the number of subjects who can transition to unsupervised robot-assisted therapy at home out of the total number of tested subjects.
This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
Feasibility - Attendance
Tidsram: This is calculated on completion of the study protocol, i.e., at the end of the six weeks of unsupervised therapy at home.
Feasibility of unsupervised therapy with the ReHandyBot as assessed by attendance during the unsupervised phase at home. Attendance is measured as the percentage of days where the subject trains at least once without supervision out of the 42 days offered for unsupervised training at home.
This is calculated on completion of the study protocol, i.e., at the end of the six weeks of unsupervised therapy at home.
Generalizability of unsupervised therapy with the ReHandyBot
Tidsram: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
Generalizability is assessed by comparing the feasibility of the intervention across the four sites.
This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
Usability as assessed by the System Usability Scale (1)
Tidsram: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability of the ReHandyBot measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).
This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability as assessed by the System Usability Scale (2)
Tidsram: Usability is measured again after 8 weeks of intervention.
Usability of the ReHandyBot measured with the System Usability Scale. The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).
Usability is measured again after 8 weeks of intervention.
Usability as assessed by the raw NASA Task Load Index (1)
Tidsram: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability of the ReHandyBot measured with the raw NASA (National Aeronautics and Space Administration) Task Load Index. Answers range from 0 (low task load) to 100 (high task load).
This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability as assessed by the raw NASA Task Load Index (2)
Tidsram: Usability is measured again after 8 weeks of intervention.
Usability of the ReHandyBot measured with the raw NASA (National Aeronautics and Space Administration) Task Load Index. Answers range from 0 (low task load) to 100 (high task load).
Usability is measured again after 8 weeks of intervention.
Usability as assessed by the Post-Study System Usability Questionnaire (1)
Tidsram: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability of the ReHandyBot measured with the Post-Study System Usability Questionnaire (version 3). This questionnaire consists of 16 questions and the possible response options vary between 1 (strongly agree) and 7 (strongly disagree).
This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability as assessed by the Post-Study System Usability Questionnaire (2)
Tidsram: Usability is measured again after 8 weeks of intervention.
Usability of the ReHandyBot measured with the Post-Study System Usability Questionnaire (version 3). This questionnaire consists of 16 questions and the possible response options vary between 1 (strongly agree) and 7 (strongly disagree).
Usability is measured again after 8 weeks of intervention.
Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale
Tidsram: This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
A 5-point scale is presented by the robot at the end of each therapy session to measure patient's satisfaction with robot-assisted therapy. The scale ranges from 1 (low satisfaction) to 5 (high satisfaction).
This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
Usability - Intrinsic Motivation Inventory (1)
Tidsram: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability of the gaming environment is measured with the Intrinsic Motivation Inventory (items: Interest/Enjoyment). The possible response options vary between 1 (not true at all) and 7 (completely true).
This is measured at the end of the second week of intervention (at the end of the familiarization phase).
Usability - Intrinsic Motivation Inventory (2)
Tidsram: User experience is measured again after 8 weeks of intervention.
Usability of the gaming environment is measured with the Intrinsic Motivation Inventory (items: Interest/Enjoyment). The possible response options vary between 1 (not true at all) and 7 (completely true).
User experience is measured again after 8 weeks of intervention.
Change in usability
Tidsram: This is calculated at the end of the study (i.e., after 8 weeks of intervention).
Change in usability between the first and second time when it is measured. This change is used to define how the absence of the therapist during robot-assisted therapy impacts the perceived usability of the device.
This is calculated at the end of the study (i.e., after 8 weeks of intervention).
User experience - Customer Satisfaction Score (1)
Tidsram: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
The Customer Satisfaction Score consists of the question "Overall, how satisfied are you with the therapy with ReHandyBot?". The possible response options vary between 1 (extremely dissatisfied) and 5 (extremely satisfied).
This is measured at the end of the second week of intervention (at the end of the familiarization phase).
User experience - Customer Satisfaction Score (2)
Tidsram: User experience is measured again after 8 weeks of intervention.
The Customer Satisfaction Score consists of the question "Overall, how satisfied are you with the therapy with ReHandyBot?". The possible response options vary between 1 (extremely dissatisfied) and 5 (extremely satisfied).
User experience is measured again after 8 weeks of intervention.
User experience - Net Promoter Score (1)
Tidsram: This is measured at the end of the second week of intervention (at the end of the familiarization phase).
The Net Promoter Score consists of the question "How likely would you be to recommend therapy with ReHandyBot to another patient?". The possible response options vary between 1 (extremely unlikely) and 10 (extremely likely).
This is measured at the end of the second week of intervention (at the end of the familiarization phase).
User experience - Net Promoter Score (2)
Tidsram: User experience is measured again after 8 weeks of intervention.
The Net Promoter Score consists of the question "How likely would you be to recommend therapy with ReHandyBot to another patient?". The possible response options vary between 1 (extremely unlikely) and 10 (extremely likely).
User experience is measured again after 8 weeks of intervention.
Change in the user experience
Tidsram: This is calculated at the end of the study (i.e., after 8 weeks of intervention).
Change in user experience between the first and second time when it is measured. This change is used to define how the absence of the therapist during robot assisted therapy impacts user experience when training with the device.
This is calculated at the end of the study (i.e., after 8 weeks of intervention).
Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)
Tidsram: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
Change between midterm (i.e., at discharge from the clinic) and final (i.e., end of the study) upper limb functions as assessed by the FMA-UE.
This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
Change in upper limb functions as assessed by the ABILHAND
Tidsram: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
Change between midterm (i.e., at discharge from the clinic) and final (i.e. end of the study) upper limb functions as assessed by the ABILHAND scale.
This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
Change in upper limb functions as assessed by the Box and Block (BBT) test
Tidsram: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
Change between midterm (i.e., at discharge from the clinic) and final (i.e. end of the study) upper limb functions as assessed by the BBT test.
This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
Change in upper limb functions as assessed by the modified Ashworth Scale (mAS)
Tidsram: This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
Change between midterm (i.e., at discharge from the clinic) and final (i.e., end of the study) upper limb functions as assessed by the mAS.
This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
Change in proprioception as assessed by the custom robotic assessment "JND" measuring the minimum difference in hand positioning that a patient can perceive
Tidsram: This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention).
Change between baseline (i.e. beginning of the study) and final (i.e. end of the study) proprioception, defined as the minimum difference in the hand position that a patient can perceive (i.e. just noticeable difference). This is measured by the robot with a custom assessment.
This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention).
Content of robotic therapy - Intensity (repetitions of a therapy task over time)
Tidsram: This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
Intensity (i.e., repetitions of a therapy task over time) of the robotic therapy throughout the study.
This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Swiss Federal Institute of Technology

Samarbetspartners

University Hospital, Geneva
Rehaklinik Zihlschlacht AG
Rehaklinik Bellikon
Kliniken Valens

Utredare

  • Huvudutredare: Bertrand Léger, Dr., Responsible for research at the SUVA clinics (Bellikon and Sion)
  • Huvudutredare: Roman Gonzenbach, Dr. med. Dr. sc. nat., Rehaklinik Valens
  • Huvudutredare: René Müri, Prof. Dr. med., Rehaklinik Zihlschlacht AG
  • Huvudutredare: Mauro Silva, Dr. med., University Hospital, Geneva

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

30 maj 2028

Avslutad studie (Beräknad)

30 augusti 2028

Studieregistreringsdatum

Först inskickad

16 juni 2026

Först inskickad som uppfyllde QC-kriterierna

23 juni 2026

Första postat (Faktisk)

29 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juni 2026

Senast verifierad

1 juni 2026

Mer information

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Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RHB Home SNR

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