Pilot Trial of Robotic Hand Therapy After Stroke

Официальное название

Robotic-Assisted Hand Therapy for Neurorehabilitation in Adults With Hand Sensorimotor Impairments Following a Stroke: A Pilot Randomized Controlled Trial

Обзор

This pilot study will test whether the GRIP program-a soft robotic glove with virtual-reality training-can improve hand and arm function in adults undergoing inpatient rehabilitation after a recent stroke. About 20 participants will be randomly assigned to either the GRIP program or action-observation therapy with education, in addition to usual care. The study will assess motor improvement, safety, and acceptability over approximately six weeks.

Подробное описание

The goal of this pilot clinical trial is to determine whether the Glove for Rehabilitation and Interactive Practice (GRIP) program can help improve hand and arm movement in adults who have difficulty using their hand after a recent stroke. The GRIP program uses a soft robotic glove and a virtual reality training platform. It is added to the usual rehabilitation care that participants already receive.

The main questions this study aims to answer are:

* Does the GRIP program help improve hand and arm movement? * Is the GRIP program safe? * Do participants find the GRIP program acceptable, comfortable, and engaging? (qualitatively).

Researchers will compare the Glove for Rehabilitation and Interactive Practice (GRIP) program with action-observation therapy and education. Action-observation therapy means watching videos of hand movements and then practicing the same movements. Both groups will also receive their usual rehabilitation care. This study will include about 20 adults who are in an inpatient rehabilitation program after a stroke and who have difficulty using their hand.

Вмешательства

• Устройство robotic-assisted hand therapy
  Participants will receive the GRIP program in addition to usual rehabilitation care. The program uses a soft robotic glove worn on the affected hand together with a non-immersive virtual-reality system that displays hand exercises and a virtual hand that moves with the participant's real movements. The glove can provide assistance or resistance to support grasping practice and strengthening. Training focuses on repeated grasping tasks and strategies to increase use of the affected hand in daily
• Поведенческое Action-observation therapy & Education
  Participants will receive usual rehabilitation care plus action-observation therapy (AOT). They will complete ten self-directed 30-minute AOT sessions over two weeks. Each session consists of repeated cycles of watching short videos of hand movements and then attempting to reproduce those movements with the affected hand. Videos will match the grasp types practiced in the intervention arm. Participants will also attend three individual education sessions on post-stroke arm and hand recovery, inc

Первичные конечные точки

• Fugl-Meyer Assessment Upper Extremity (FMA-UE) [Срок оценки: At enrollment , post-intervention (at 2 weeks), and 1 month follow-up (at 6 weeks)]

Вторичные конечные точки (1)

• Action Research Arm Test [Срок оценки: At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)]

Критерии участия

Критерии включения

• First unilateral stroke (<6-month post-stroke at enrollment)
• ≥18 years old
• Hand sensorimotor impairments
• Able to understand and follow a two-step instruction
• Admitted to the rehabilitation center and participating in the stroke program

Критерии исключения

• Severe spasticity (score ≥3 on the Modified Ashworth Scale)
• Unilateral spatial neglect
• Moderate to severe hand pain
• Significant motor impairment of the fingers (active finger flexion/extension less than 10°)
• Any medical condition that may interfere with participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Institut de réadaptation Gingras-Lindsay-de-Montréal — Montreal

Идентификаторы

NCT: NCT07706621 · 2026-2490

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗