Digital Technology-Informed Stroke Rehabilitation

Обзор

The goal of this study is to determine the effects of lab and home-based technology guidance during movement training post-stroke. The study will compare movement training informed by lab-based technology to training delivered with technology at home. The main questions it aims to answer are: * How well do lab and home-based technologies help individuals post-stroke improve their movement patterns? * Is there a difference in improvement between the in-lab and at-home training groups? * Which technologies lead to the most improvement?

Подробное описание

The study is a randomized, controlled feasibility trial investigating rehabilitation to improve movement patterns after stroke. The study will recruit participants who have had a stroke that led to upper-extremity impairment. Individuals will be assigned to one of two digital technology-guided groups. One group will be guided through exercises in a home-based setting, the other will be lab-based.

Participants will engage in training sessions multiple days a week for up to 6 weeks, either in-lab or at home. Both groups will visit the lab weekly for movement assessments.

Вмешательства

• Другое Lab-based movement guidance
  Participants will receive computer-generated guidance on how to perform different activities of daily living efficiently. The guidance will be delivered using lab-based sensing and feedback technology.
• Другое Home-based movement guidance
  Participants will receive computer-generated guidance on how to perform different activities of daily living efficiently. This guidance will be delivered using home-based technologies, such as a computer or tablet.

Первичные конечные точки

• Kinematic movement quality score [Срок оценки: From enrollment to the end of treatment at 3 weeks.]

Вторичные конечные точки (1)

• FMA-UE Score [Срок оценки: From enrollment to the end of treatment at 3 weeks.]

Критерии участия

Критерии включения

• Age between 30-85 years.
• Diagnosis of stroke.
• Stroke onset of at least six months prior to the time of participation.
• Fugl Meyer Upper Extremity between 30-50 (mild-moderate)
• Cognitive skills to consent and actively participate, as indicated by scores of ≥ 24 on the Mini- Mental Status Examination
• Able to visit lab up to 5x per week for 3 weeks

Критерии исключения

• Presence of severe aphasia preventing the ability to follow 1-step directions at least 80% of the time.
• Excessive spasticity of the wrist, elbow, and shoulder, defined as a Modified Ashworth Score >2.
• Diagnosis of neurological disorders other than stroke.
• Orthopedic/musculoskeletal conditions (e.g., severe arthritis) affecting the upper extremity.
• Currently or planning to become pregnant.
• Participation in concurrent occupational therapy.
• Unilateral neglect, defined as failure of the Line Bisection Task
• Upper extremity pain >= 7/10 on Numeric Rating Scale

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Kennecott Mechanical Engineering Building — Salt Lake City

Идентификаторы

NCT: NCT07698522 · IRB_00203244

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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