Passive Robots for Stroke Rehabilitation: A Feasibility Study
Stroke
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
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.
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
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
University of Michigan - NeuRRo LabAnn Arbor, Michigan, United StatesReclutando
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
Título oficial del estudio
Passive Robots for Stroke Rehabilitation
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
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
