Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation

Обзор

This research program aims at investigating the effects of upper-limb robotic therapy primed with interactive exergaming as an innovative hybrid regimen in stroke rehabilitation.

Подробное описание

Robotic therapy can potentially be a movement-based priming technique to promote rebalancing of cortical excitability and create an enriched neuroplastic environment by priming the brain to facilitate motor and functional recovery. The proximal priority and distal priority robotic priming techniques may bring differential effects. This proposed research project aims to: (1) examine the effects of proximal priority versus distal priority of bilateral robotic priming combined with exergaming on sensorimotor function, daily function, self-efficacy, quality of life, and motor control strategy in patients with stroke, (2) investigate the 3-month retention effects of the three approaches, and (3) identify the potential predictors of functionally relevant changes after therapy.

Вмешательства

• Другое robotic practice
  According to the group assignment, participants will start from the BMT proximal mode (i.e., forearm pronation-supination movement), and then the distal mode (i.e., wrist flexion-extension movement), and vice versa. Each participant is expected to complete approximately 400 to 600 repetitions of the proximal mode session (i.e., forearm movements) and another 400 to 600 repetitions of the distal mode session (i.e., wrist movements), respectively.
• Другое kinetic exergaming
  All of the participants in experimental and comparison groups will practice on the exergaming for 30 minutes per session. To avoid fatigue, the four domains of programs will be provided alternately. Each program will be executed for approximately 5 minutes with warm-up, followed by a 2-minute break between programs, and cool-down. The games will be selected and adapted according to the personal capacity, the occupational role, and the rehabilitation goal of each participant. The investigators wi
• Другое conventional therapy
  Participants in control group will receive 30 minutes of therapist-mediated conventional therapy per session. The training protocols of the conventional therapy will use occupational therapy techniques, such as neurodevelopmental techniques and functional task training. The therapy will be adapted to the participants' levels of motor deficits and their personal needs. The protocol will include affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or

Первичные конечные точки

• Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks and 18 weeks [Срок оценки: Baseline, 6 weeks, and 18 weeks]
• Change from Baseline 10 meter walk test (10-MWT) at 6 weeks and 18 weeks [Срок оценки: Baseline, 6 weeks, and 18 weeks]

Вторичные конечные точки (5)

• Medical Research Council scale (MRC) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
• The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
• Functional Independence Measure (FIM) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
• Stroke Self-Efficacy Questionnaire (SSEQ) [Срок оценки: Baseline, 6 weeks, and 18 weeks]
• Adverse events (pain and fatigue) [Срок оценки: through study completion, an average of 18 weeks]

Критерии участия

Критерии включения

• a first ever-stroke≧3 months
• age range between 20 to 80 years
• baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56
• no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale < 3 at any joints)
• able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22)
• can maintain a step-standing position for at least 30 seconds
• can walk for at least 10 meters with or without device
• no participation in further experimental rehabilitation or drug studies during the duration of the project

Критерии исключения

• acute inflammation and pain
• concomitant neurologic, neuromuscular or orthopedic conditions that may impede participation in this research.

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

Тайвань · 4 центра

• Feng Yuan Hospital, Ministry of Health and Welfare — Taichung
• National Taiwan University Hospital — Taipei
• Taipei Municipal Wan Fang Hospital — Taipei
• Taipei Tzu Chi Hospital — Taipei

Публикации

• Wu SY, Li YC, Chen YW, Chen CL, Pan HC, Lin KC, Lau HY. Construct validity, responsiveness, minimal detectable change, and minimal clinically important difference of the stroke self-efficacy questionnaire in individuals receiving stroke rehabilitation. Disabil Rehabil. 2024 Dec;46(25):6195-6203. doi: 10.1080/09638288.2024.2324122. Epub 2024 Mar 3. PMID 38433459

Идентификаторы

NCT: NCT05492175 · 10-M-161

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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