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ReclutandoNCT07218276Registro de ClinicalTrials.gov

Passive Robots for Stroke Rehabilitation: A Feasibility Study

Stroke

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - 75 años
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
4 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The purpose of this study is to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive neuromuscular stimulation for upper extremity rehabilitation after stroke.

Leer la descripción completa

About 800,000 individuals suffer from a stroke every year in the United States. The majority of stroke survivors often experience lingering deficits in upper extremity function. High-end robotic devices can improve outcomes and clinical productivity; however, these devices are expensive and bulky, making them not practical for many clinical or home environments. This study aims to evaluate the feasibility of low-cost non-motorized devices for stroke rehabilitation in a long-term intervention. The intervention will involve training with a table-top, semi-passive (i.e., no motors) exercise equipment called SepaRRo and commonly-used neuromuscular stimulation. The stimulation will be provided during functional activities using a custom controller (NeuRRoFES) to trigger stimulation. These instruments are designed to provide flexible, compliant assistance/resistance to improve upper extremity function and can be used in a home setting. The study will measure technical feasibility (e.g., qualitative survey, adherence, time on task, retention, ability to perform tasks) as well as clinical feasibility (i.e., changes in biomechanical, neurophysiological, and functional measures) of an intervention with these devices in stroke survivors. The findings aim to support the development of affordable, home-use rehabilitation systems for stroke patients.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

  • Age 18 to 75 years;
  • Ischemic or hemorrhagic stroke confirmed by CT, MRI, or clinical criteria;
  • No major deficits of sensation or proprioception;

Exclusion Criteria:

  • Bilateral stroke
  • Unable to think clearly and remember (Mini-Mental State Exam score \< 22 and miniMOCA \< 8);
  • Uncontrolled Diabetes or Hypertension;
  • Severe limitations of joint range of motion that will lead to inability of testing
  • Severe spasticity and joint contractures that will lead to inability of testing
  • Complete paresis with no possible movements
  • Severe aphasia
  • Any other medical condition that will significantly impact the study results
  • Unable to obtain reliable motor evoked potentials
  • Are pregnant or are actively trying to conceive
  • Have a recent history of repeated fainting spells or syncope.
  • Have a recent history of seizure (epilepsy) while on anti-seizure medication
  • Have a recent history of skull fracture/head injury
  • Have metal implants in the skull
  • Have cardiac pacemakers
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No aplica
Enmascaramiento
Sin enmascaramiento
Robotic Intervention

Participants will receive upper extremity rehabilitation using SepaRRo and NeuRRoFES 2-5 times per week for 2-6 weeks

Device: Functional Training with SepaRRo and NeuRRoFES

Functional Training with SepaRRo and NeuRRoFES DEVICE

Participants will perform functional movements (e.g., reach for targets) with their extremities. During movements, the devices will be used to assist or resist their motion. Participants may receive biofeedback of their movements to better engage them in training. Participants may receive assistance from the devices (including neuromuscular stimulation) and/or their less-impaired limb.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Device Survey For Feasibility

Plazo: Post-intervention (immediately following last session of intervention)

Subjective feedback regarding feasibility of the device for training

Otras medidas

Retention

Plazo: Post-intervention (immediately following last session of intervention)

Measure of how many participants completed intervention

Adherence

Plazo: Post-intervention (immediately following last session of intervention)

Measure of percentage of sessions completed

Upper extremity Fugl-Meyer Score

Plazo: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively.

Changes in upper extremity Fugl-Meyer score from before the intervention (from baseline) to after its completion using publicly available scoring sheets. The Fugl-Meyer score is a measure of functional impairment and runs from 0 to 66 points, with higher numbers reflecting better outcome.

Reachable workspace

Plazo: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in reachable workspace from before the intervention (from baseline) to after its completion). The reachable workspace area will be measured with SepaRRo obtained from optical encoders mounted in the device.

Voluntary hand opening

Plazo: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in voluntary ability to open the hand from before the intervention (from baseline to after its completion). Voluntary hand opening will be measured with motion capture equipment.

Action Research Arm Test Score

Plazo: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in the Action Research Arm Test Score from before the intervention (from baseline) to after its completion using publicly available scoring sheets. The Action Research Arm Test is a measure of arm functional ability and runs from 0 to 57 points, with higher numbers reflecting better outcome.

Box and Block (BBT)

Plazo: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in functional measure of arm disability (BBT) from before the intervention (from baseline) to after its completion using publicly available scoring sheets.

Hand Strength

Plazo: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in force produced by the hand from before the intervention (from baseline) to after its completion as measured by force production recorded with a dynamometer

Arm strength

Plazo: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in force produced by the arm from before the intervention (from baseline) to after its completion as measured by force production recorded with a dynamometer

Muscle coordination

Plazo: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in muscle coordination of the upper extremity muscles as measured using surface electromyography between before the intervention (from baseline) to after its completion.

Joint coordination

Plazo: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in coordination of the upper extremity joints as measured motion capture between before the intervention (from baseline) to after its completion.

Corticospinal excitability

Plazo: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in corticospinal excitability of the upper extremity muscles as measured using surface electromyography and transcranial magnetic stimulation between before the intervention (from baseline) to after its completion

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

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1 centros

University of Michigan - NeuRRo LabAnn Arbor, Michigan, United StatesReclutando
Thomas E. Augenstein, PhDCONTACTtomaugen@umich.edu(734) 936-4031
Chandramouli Krishnan, PT PhDPRINCIPAL_INVESTIGATOR
Ver ubicación en el mapa ↗

Equipo y fechas

Patrocinador principal
University of Michigan
Inicio del estudio
5 nov 2025 Real
Finalización primaria
1 oct 2027 Estimado
Finalización del estudio
1 oct 2027 Estimado
Primera publicación
20 oct 2025 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Chandramouli Krishnan, PT, PhDCONTACTmouli@umich.edu7349364031
Thomas E Augenstein, PhDCONTACTtomaugen@umich.edu7342320898
Título oficial del estudio

Passive Robots for Stroke Rehabilitation

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026