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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 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Sveits
      • Bellikon, Sveits, 5454
      • Geneva, Sveits, 1211
      • Valens, Sveits, 7317
      • Zihlschlacht, Sveits, 8588

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dose av terapi uten tilsyn - minutter
Tidsramme: Dette måles under intervensjonen (dvs. i løpet av de seks ukene med uovervåket behandling hjemme).
Daglig dose i minutter med selvadministrert robotassistert terapi utført av forsøkspersoner i hjemmemiljøet uten tilsyn.
Dette måles under intervensjonen (dvs. i løpet av de seks ukene med uovervåket behandling hjemme).
Dose av terapi uten tilsyn - Repetisjoner
Tidsramme: Dette måles under intervensjonen (dvs. i løpet av de seks ukene med uovervåket behandling hjemme).
Daglig dose i antall oppgaverepetisjoner av selvadministrert robotassistert terapi utført av forsøkspersoner i hjemmemiljøet uten tilsyn.
Dette måles under intervensjonen (dvs. i løpet av de seks ukene med uovervåket behandling hjemme).
Dose av terapi uten tilsyn - Prosentvis endring i terapitid
Tidsramme: Dette måles under intervensjonen (dvs. i løpet av de seks ukene med uovervåket behandling hjemme).
Prosentvis økning i terapitid på grunn av den uovervåkede robotterapien sammenlignet med tilfellet hvor deltakerne kun ville utføre konvensjonell (dvs. normalt foreskrevet) terapi.
Dette måles under intervensjonen (dvs. i løpet av de seks ukene med uovervåket behandling hjemme).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gjennomførbarhet - Uønskede hendelser
Tidsramme: Dette overvåkes over hele protokollvarigheten (dvs. fra begynnelsen av den første uken til slutten av de seks ukene med uovervåket behandling hjemme).
Gjennomførbarheten av terapi med ReHandyBot vurdert ut fra antall uønskede hendelser som oppstår under denne studien.
Dette overvåkes over hele protokollvarigheten (dvs. fra begynnelsen av den første uken til slutten av de seks ukene med uovervåket behandling hjemme).
Gjennomførbarhet - Enhetsmangler
Tidsramme: Dette overvåkes over hele protokollvarigheten (dvs. fra begynnelsen av den første uken til slutten av de seks ukene med uovervåket behandling hjemme).
Gjennomførbarheten av terapi med ReHandyBot, vurdert ut fra antall enhetsmangler som oppstår under denne studien.
Dette overvåkes over hele protokollvarigheten (dvs. fra begynnelsen av den første uken til slutten av de seks ukene med uovervåket behandling hjemme).
Endring i det aktive bevegelsesområdet (aROM) for griping målt i millimeter som vurdert av den tilpassede robotvurderingen "aROM - Hand"
Tidsramme: Dette beregnes ved slutten av studien, etter å ha utført de siste målingene (dvs. ved slutten av de seks ukene med uovervåket behandling hjemme).
Bytt mellom baseline (dvs. begynnelsen av studiet) og siste (dvs. slutten av studien) aROM for å gripe, dvs. for håndåpning og lukking. Dette måles av roboten med en tilpasset vurdering.
Dette beregnes ved slutten av studien, etter å ha utført de siste målingene (dvs. ved slutten av de seks ukene med uovervåket behandling hjemme).
Endring i haptisk persepsjon som vurdert av den tilpassede robotvurderingen "Weber Fraction" som måler minimumsforskjellen i stivhet som en pasient kan oppfatte i prosent
Tidsramme: Dette beregnes ved slutten av studien, etter å ha utført de siste målingene (dvs. ved slutten av de seks ukene med uovervåket behandling hjemme).
Bytt mellom baseline (dvs. begynnelsen av studiet) og siste (dvs. slutten av studien) haptisk persepsjon, definert som minimumsforskjellen i stivhet som en pasient kan oppfatte uttrykt i prosent i henhold til Weber-fraksjonsloven. Dette måles av roboten med en tilpasset vurdering kalt "Weber-fraksjon".
Dette beregnes ved slutten av studien, etter å ha utført de siste målingene (dvs. ved slutten av de seks ukene med uovervåket behandling hjemme).
Innhold i robotterapi - Ytelse
Tidsramme: Dette overvåkes over hele protokollvarigheten (dvs. fra begynnelsen av den første uken til slutten av de seks ukene med uovervåket behandling hjemme).
Oppgaveutførelse (dvs. korrekte forsøk fremfor totale forsøk) under robotterapi gjennom hele studien.
Dette overvåkes over hele protokollvarigheten (dvs. fra begynnelsen av den første uken til slutten av de seks ukene med uovervåket behandling hjemme).
Innhold i robotterapi - Effektivt tidsforhold
Tidsramme: Dette overvåkes over hele protokollvarigheten (dvs. fra begynnelsen av den første uken til slutten av de seks ukene med uovervåket behandling hjemme).
Forholdet mellom effektiv (dvs. netto total terapitid uten pauser) over total varighet av terapiøkten under robotterapi gjennom hele studien.
Dette overvåkes over hele protokollvarigheten (dvs. fra begynnelsen av den første uken til slutten av de seks ukene med uovervåket behandling hjemme).
Parametre som påvirker uovervåket robotassistert terapi
Tidsramme: Dette beregnes ved slutten av studien (dvs. ved slutten av de seks ukene med uovervåket behandling hjemme).
Korrelasjon mellom oppnådd uovervåket robotassistert terapidose og ulike parametere (dvs. kognitive vurderinger (Goodglass-Kaplan Scale, LCF-R, Montreal Cognitive Assessment (MoCA)) utført under screeningbesøket, de kliniske vurderingene, robotvurderingene, demografi og de innsamlede medisinske dataene).
Dette beregnes ved slutten av studien (dvs. ved slutten av de seks ukene med uovervåket behandling hjemme).
Feasibility - Subjects performing unsupervised robot-assisted training
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Swiss Federal Institute of Technology

Samarbeidspartnere

University Hospital, Geneva
Rehaklinik Zihlschlacht AG
Rehaklinik Bellikon
Kliniken Valens

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

30. mai 2028

Studiet fullført (Antatt)

30. august 2028

Datoer for studieregistrering

Først innsendt

16. juni 2026

Først innsendt som oppfylte QC-kriteriene

23. juni 2026

Først lagt ut (Faktiske)

29. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RHB Home SNR

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

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Nei

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