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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 junio de 2026 actualizado 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Suiza
      • Bellikon, Suiza, 5454
      • Geneva, Suiza, 1211
        • University Hospital, Geneva
        • Contacto:
      • Valens, Suiza, 7317
      • Zihlschlacht, Suiza, 8588
        • Rehaklinik Zihlschlacht AG
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dosis de terapia no supervisada - Actas
Periodo de tiempo: Esto se mide durante la intervención (es decir, durante las seis semanas de terapia no supervisada en casa).
Dosis diaria en minutos de terapia asistida por robot autoadministrada realizada por sujetos en el hogar sin supervisión.
Esto se mide durante la intervención (es decir, durante las seis semanas de terapia no supervisada en casa).
Dosis de terapia no supervisada - Repeticiones
Periodo de tiempo: Esto se mide durante la intervención (es decir, durante las seis semanas de terapia no supervisada en casa).
Dosis diaria en número de repeticiones de tareas de terapia asistida por robot autoadministrada realizada por sujetos en el hogar sin supervisión.
Esto se mide durante la intervención (es decir, durante las seis semanas de terapia no supervisada en casa).
Dosis de terapia no supervisada: cambio porcentual en el tiempo de terapia
Periodo de tiempo: Esto se mide durante la intervención (es decir, durante las seis semanas de terapia no supervisada en casa).
Aumento porcentual en el tiempo de terapia debido a la terapia robótica no supervisada en comparación con el caso en el que los participantes realizarían únicamente la terapia convencional (es decir, normalmente prescrita).
Esto se mide durante la intervención (es decir, durante las seis semanas de terapia no supervisada en casa).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Factibilidad - Eventos adversos
Periodo de tiempo: Esto se controla durante toda la duración del protocolo (es decir, desde el comienzo de la primera semana hasta el final de las seis semanas de terapia no supervisada en casa).
Viabilidad de la terapia con ReHandyBot según la evaluación de la cantidad de eventos adversos que ocurrieron durante este estudio.
Esto se controla durante toda la duración del protocolo (es decir, desde el comienzo de la primera semana hasta el final de las seis semanas de terapia no supervisada en casa).
Viabilidad - Deficiencias del dispositivo
Periodo de tiempo: Esto se controla durante toda la duración del protocolo (es decir, desde el comienzo de la primera semana hasta el final de las seis semanas de terapia no supervisada en casa).
Viabilidad de la terapia con ReHandyBot según la evaluación de la cantidad de deficiencias del dispositivo que ocurrieron durante este estudio.
Esto se controla durante toda la duración del protocolo (es decir, desde el comienzo de la primera semana hasta el final de las seis semanas de terapia no supervisada en casa).
Cambio en el rango de movimiento activo (aROM) para agarrar medido en milímetros según lo evaluado por la evaluación robótica personalizada "aROM - Hand"
Periodo de tiempo: Esto se calcula al final del estudio, después de realizar las mediciones finales (es decir, al final de las seis semanas de terapia no supervisada en casa).
Cambio entre la línea de base (es decir, inicio del estudio) y final (es decir. final del estudio) aROM para agarrar, es decir, para abrir y cerrar la mano. Esto lo mide el robot con una evaluación personalizada.
Esto se calcula al final del estudio, después de realizar las mediciones finales (es decir, al final de las seis semanas de terapia no supervisada en casa).
Cambio en la percepción háptica según lo evaluado por la evaluación robótica personalizada "Fracción Weber" que mide la diferencia mínima en rigidez que un paciente puede percibir en porcentaje
Periodo de tiempo: Esto se calcula al final del estudio, después de realizar las mediciones finales (es decir, al final de las seis semanas de terapia no supervisada en casa).
Cambio entre la línea de base (es decir, inicio del estudio) y final (es decir. final del estudio) percepción háptica, definida como la diferencia mínima de rigidez que un paciente puede percibir expresada en porcentaje según la ley de la fracción de Weber. Esto lo mide el robot con una evaluación personalizada denominada "fracción Weber".
Esto se calcula al final del estudio, después de realizar las mediciones finales (es decir, al final de las seis semanas de terapia no supervisada en casa).
Contenido de la terapia robótica - Rendimiento
Periodo de tiempo: Esto se controla durante toda la duración del protocolo (es decir, desde el comienzo de la primera semana hasta el final de las seis semanas de terapia no supervisada en casa).
Realización de tareas (es decir, ensayos correctos sobre el total de ensayos) durante la terapia robótica durante todo el estudio.
Esto se controla durante toda la duración del protocolo (es decir, desde el comienzo de la primera semana hasta el final de las seis semanas de terapia no supervisada en casa).
Contenido de la terapia robótica - Relación de tiempo efectivo
Periodo de tiempo: Esto se controla durante toda la duración del protocolo (es decir, desde el comienzo de la primera semana hasta el final de las seis semanas de terapia no supervisada en casa).
Relación de duración efectiva (es decir, tiempo total neto de terapia sin interrupciones) sobre la duración total de la sesión de terapia durante la terapia robótica durante todo el estudio.
Esto se controla durante toda la duración del protocolo (es decir, desde el comienzo de la primera semana hasta el final de las seis semanas de terapia no supervisada en casa).
Parámetros que influyen en la terapia asistida por robot no supervisada
Periodo de tiempo: Esto se calcula al final del estudio (es decir, al final de las seis semanas de terapia no supervisada en casa).
Correlación entre la dosis de terapia asistida por robot no supervisada lograda y diferentes parámetros (es decir, evaluaciones cognitivas (Escala Goodglass-Kaplan, LCF-R, Evaluación Cognitiva de Montreal (MoCA)) realizadas durante la visita de selección, las evaluaciones clínicas, las evaluaciones robóticas, la demografía y los datos médicos recopilados).
Esto se calcula al final del estudio (es decir, al final de las seis semanas de terapia no supervisada en casa).
Feasibility - Subjects performing unsupervised robot-assisted training
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

30 de mayo de 2028

Finalización del estudio (Estimado)

30 de agosto de 2028

Fechas de registro del estudio

Enviado por primera vez

16 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2026

Publicado por primera vez (Actual)

29 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RHB Home SNR

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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