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

23 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Dispositivo: 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.
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Dose de terapia não supervisionada – Minutos
Prazo: Isto é medido durante a intervenção (ou seja, durante as seis semanas de terapia não supervisionada em casa).
Dose diária em minutos de terapia autoadministrada assistida por robô realizada por sujeitos em ambiente domiciliar sem supervisão.
Isto é medido durante a intervenção (ou seja, durante as seis semanas de terapia não supervisionada em casa).
Dose de terapia não supervisionada – Repetições
Prazo: Isto é medido durante a intervenção (ou seja, durante as seis semanas de terapia não supervisionada em casa).
Dose diária em número de repetições de tarefas de terapia autoadministrada assistida por robô realizada por sujeitos em ambiente domiciliar sem supervisão.
Isto é medido durante a intervenção (ou seja, durante as seis semanas de terapia não supervisionada em casa).
Dose de terapia não supervisionada – Alteração percentual no tempo de terapia
Prazo: Isto é medido durante a intervenção (ou seja, durante as seis semanas de terapia não supervisionada em casa).
Aumento percentual no tempo de terapia devido à terapia robótica não supervisionada em comparação com o caso em que os participantes realizariam apenas terapia convencional (isto é, normalmente prescrita).
Isto é medido durante a intervenção (ou seja, durante as seis semanas de terapia não supervisionada em casa).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Viabilidade - Eventos adversos
Prazo: Isto é monitorado durante toda a duração do protocolo (ou seja, desde o início da primeira semana até o final das seis semanas de terapia não supervisionada em casa).
Viabilidade da terapia com o ReHandyBot avaliada pelo número de eventos adversos ocorridos durante este estudo.
Isto é monitorado durante toda a duração do protocolo (ou seja, desde o início da primeira semana até o final das seis semanas de terapia não supervisionada em casa).
Viabilidade - Deficiências do dispositivo
Prazo: Isto é monitorado durante toda a duração do protocolo (ou seja, desde o início da primeira semana até o final das seis semanas de terapia não supervisionada em casa).
Viabilidade da terapia com o ReHandyBot avaliada pelo número de deficiências do dispositivo que ocorrem durante este estudo.
Isto é monitorado durante toda a duração do protocolo (ou seja, desde o início da primeira semana até o final das seis semanas de terapia não supervisionada em casa).
Alteração na amplitude de movimento ativa (aROM) para preensão, medida em milímetros, avaliada pela avaliação robótica personalizada "aROM - Mão"
Prazo: Isto é calculado no final do estudo, após a realização das medições finais (ou seja, no final das seis semanas de terapia não supervisionada em casa).
Mudança entre a linha de base (ou seja, início do estudo) e final (ou seja, final do estudo) aROM para agarrar, ou seja, para abrir e fechar a mão. Isso é medido pelo robô com uma avaliação personalizada.
Isto é calculado no final do estudo, após a realização das medições finais (ou seja, no final das seis semanas de terapia não supervisionada em casa).
Mudança na percepção háptica avaliada pela avaliação robótica personalizada "Weber Fraction", que mede a diferença mínima na rigidez que um paciente pode perceber em porcentagem
Prazo: Isto é calculado no final do estudo, após a realização das medições finais (ou seja, no final das seis semanas de terapia não supervisionada em casa).
Mudança entre a linha de base (ou seja, início do estudo) e final (ou seja, final do estudo) percepção háptica, definida como a diferença mínima de rigidez que um paciente pode perceber expressa em porcentagem de acordo com a lei da Fração de Weber. Isso é medido pelo robô com uma avaliação personalizada chamada "fração de Weber".
Isto é calculado no final do estudo, após a realização das medições finais (ou seja, no final das seis semanas de terapia não supervisionada em casa).
Conteúdo da terapia robótica – Desempenho
Prazo: Isto é monitorado durante toda a duração do protocolo (ou seja, desde o início da primeira semana até o final das seis semanas de terapia não supervisionada em casa).
Desempenho da tarefa (ou seja, tentativas corretas em relação ao total de tentativas) durante a terapia robótica ao longo do estudo.
Isto é monitorado durante toda a duração do protocolo (ou seja, desde o início da primeira semana até o final das seis semanas de terapia não supervisionada em casa).
Conteúdo da terapia robótica – Proporção de tempo efetivo
Prazo: Isto é monitorado durante toda a duração do protocolo (ou seja, desde o início da primeira semana até o final das seis semanas de terapia não supervisionada em casa).
Proporção entre eficácia (ou seja, tempo total líquido de terapia sem pausas) sobre a duração total da sessão de terapia durante a terapia robótica ao longo do estudo.
Isto é monitorado durante toda a duração do protocolo (ou seja, desde o início da primeira semana até o final das seis semanas de terapia não supervisionada em casa).
Parâmetros que influenciam a terapia assistida por robô não supervisionada
Prazo: Isto é calculado no final do estudo (ou seja, no final das seis semanas de terapia não supervisionada em casa).
Correlação entre a dose de terapia assistida por robô não supervisionada alcançada e diferentes parâmetros (ou seja, avaliações cognitivas (Escala Goodglass-Kaplan, LCF-R, Avaliação Cognitiva de Montreal (MoCA)) realizadas durante a visita de triagem, as avaliações clínicas, as avaliações robóticas, dados demográficos e os dados médicos coletados).
Isto é calculado no final do estudo (ou seja, no final das seis semanas de terapia não supervisionada em casa).
Feasibility - Subjects performing unsupervised robot-assisted training
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Swiss Federal Institute of Technology

Colaboradores

University Hospital, Geneva
Rehaklinik Zihlschlacht AG
Rehaklinik Bellikon
Kliniken Valens

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

30 de maio de 2028

Conclusão do estudo (Estimado)

30 de agosto de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

16 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de junho de 2026

Primeira postagem (Real)

29 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RHB Home SNR

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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