Robot-Assisted Tai Chi for Upper Limb Rehabilitation in Stroke Patients

Официальное название

Robot-Assisted Tai Chi for Upper Limb Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial on Motor Recovery

Обзор

This study aims to compare the effectiveness of Robot-Assisted Tai Chi Training (RATT) versus conventional rehabilitation in improving upper limb motor function post-stroke, and to explore the neuromuscular mechanisms of RATT. Participants will be randomly assigned to one of two groups: 1. Robot-Assisted Tai Chi Training group: Participants will receive guided Tai Chi arm movements with robotic assistance to enhance coordination and strength. 2. Conventional rehabilitation group: Participants will perform standard exercises (e.g., stretching, repetitive task practice). Both groups will receive 60-minute sessions, administered 5 days a week, over 4 weeks. Researchers will measure improvements using clinical scales (e.g., Fugl-Meyer Assessment) and monitor safety.

Вмешательства

• Устройство Robot-Assisted Tai Chi Training
  This intervention involves robot-assisted Tai Chi training for upper limb rehabilitation, delivered in a seated position to ensure participant safety and comfort. Each 60-minute session consists of a 5-minute warm-up/preparation phase, followed by three 15-minute segmented functional training phases incorporating Tai Chi-inspired movements to target upper limb coordination, range of motion, and strength recovery, interspersed with two 5-minute rest intervals. The protocol is administered 5 times
• Поведенческое Conventional rehabilitation training
  This intervention follows evidence-based clinical guidelines for post-stroke upper limb rehabilitation, focusing on therapist-guided task-oriented training that integrates activities of daily living (ADL) such as table wiping and clothes hanging. Sessions emphasize progressive functional integration, with exercises adjusted weekly based on patient performance. Training is delivered in 60-minute sessions (1 session/day), 5 days per week over 4 weeks, under direct therapist supervision to ensure p

Первичные конечные точки

• Fugl-Meyer Upper Extremity Scale [Срок оценки: 4 weeks (post-intervention)]

Вторичные конечные точки (6)

• Wolf Motor Function Test [Срок оценки: 4 weeks]
• Shoulder Range of Motion [Срок оценки: 4 weeks]
• Upper Limb Muscle Strength Assessment [Срок оценки: 4 weeks]
• Trunk Impairment Scale [Срок оценки: 4 weeks]
• Modified Barthel Index [Срок оценки: 4 weeks]
• Stroke-Specific Quality of Life Scale [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Diagnosed with stroke confirmed by neuroimaging (CT/MRI).
• Fugl-Meyer Assessment for Upper Extremity score of 8-44.
• First-ever stroke, with unilateral hemiplegia and time since onset ≤12 months.
• Aged 40-80 years, regardless of gender.
• Voluntarily participated and provided written informed consent. Participants meeting all above criteria were enrolled.

Критерии исключения

• Severe cognitive impairment (Montreal Cognitive Assessment score <10).
• Poor sitting balance (< Grade 2) or inability to maintain seated position for >60 minutes.
• Hypertonia (modified Ashworth Scale score >2 in affected limb).
• Significant hemiplegic shoulder pain (Visual Analogue Scale >3).
• Severe aphasia (Boston Diagnostic Aphasia Examination score <3).
• Severe visual impairment precluding robot-assisted upper limb training.
• Moderate-to-severe depression (17-item Hamilton Depression Rating Scale score >17).
• Pre-existing neuromuscular disorders, active malignancies, or uncontrolled systemic diseases (cardiac, renal, hepatic).
• Concurrent participation in other clinical trials affecting study outcomes. Participants meeting any of the above criteria were excluded.

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

Китай · 2 центра

• Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine — Фучжоу
• The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicin — Фучжоу

Идентификаторы

NCT: NCT06897631 · FujianUTCM-4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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