Reaching the Unreached: Home-Based Telerehabilitation for Stroke Survivors

Официальное название

Reaching the Unreached: Randomized Trial of Home-Based Telerehabilitation for Stroke Without Outpatient Care

Обзор

After a stroke, many people have trouble using their arms and hands. This can make daily tasks-like eating, dressing, or writing-very hard. In Alberta, especially in small towns and rural areas, many stroke survivors go home from the hospital without being referred to rehabilitation. As a result, they miss out on therapy that could help them get better. This project will test a new way to bring rehabilitation directly into people's homes using telerehabilitation. We will work with 200 stroke survivors across Alberta who did not get regular outpatient rehab. Participants will use the clinically validated Tenzr system-a set of fun, game-like exercises with wearable sensors. Therapists will check in and guide them remotely. When participants are enrolled in the study, they will be randomized (1:1) into two groups. The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline, while the Delayed group will receive 8 weeks of observation (usual care) followed by 8 weeks of the same telerehabilitation intervention. Everyone in the study will be tested at the baseline, 8 weeks, and 16 weeks. At 16 weeks, we will also interview them to gather their feedback on the telerehabilitation. We want to learn if this program helps people improve arm and hand movement, if it's easy to use, and if people like it. We also want to see if it could be offered more widely across Alberta in the future. The goal is to give more people access to stroke rehabilitation, no matter where they live.

Вмешательства

• Другое Standard of Care (SOC)
  8 weeks of standard of care for patients discharged from hospital without referrals to outpatient rehabilitation.
• Другое Telerehabilitation with Tenzr
  8 weeks of telerehabilitation at home supported by a remote therapist utilizing the Tenzr application.

Первичные конечные точки

• Change in Upper Extremity Fugl-Meyer Assessment for Upper Extremity (FM-UE) [Срок оценки: Baseline, 8 weeks and 16 weeks.]

Вторичные конечные точки (4)

• Change in Nine-hole Peg Test (NHPT) (sec) [Срок оценки: Baseline, 8 weeks, 16 weeks]
• Change in Box and Blocks Test (number of blocks) [Срок оценки: Baseline, 8 weeks, 16 weeks]
• Change in Stroke Impact Scale Score [Срок оценки: Baseline, 8 weeks, 16 weeks]
• Change in PROMIS Upper Extremity Short Form [Срок оценки: Baseline, 8 weeks, 16 weeks]

Критерии участия

Критерии включения

• Not currently referred to, or participating in, upper extremity outpatient rehabilitation.
• A confirmed stroke diagnosis (ischemic or hemorrhagic)
• Have moderate-to-severe upper limb impairment
• Live at home
• Have access to internet and appropriate devices to have a virtual assessment with clinicians.
• ≥ 18 years of age

Критерии исключения

• Referred to or currently participating in upper extremity outpatient rehabilitation.
• Severe cognitive, communication, or medical comorbidities that would preclude safe home-based exercise
• Don't have access to internet and appropriate devices to have a virtual assessment with clinicians.
• < 18 years of age

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Glenrose Rehabilitation Hospital — Edmonton

Идентификаторы

NCT: NCT07467785 · Pro00157166

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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