Clinical trial NCT06897631: Robot-Assisted Tai Chi for Upper Limb Rehabilitation in Stroke Patients
Official title: Robot-Assisted Tai Chi for Upper Limb Rehabilitation in Post-Stroke Patients: a Randomized Controlled Trial on Motor Recovery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
upper limb
robot
tai chi
motor function
Lead sponsor: Fujian University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with stroke confirmed by neuroimaging (CT/MRI).
2. Brunnstrom Upper Extremity Stage Ⅱ- III.
3. First-ever stroke with unilateral hemiplegia.
4. Aged 40-80 years, regardless of gender.
5. Voluntarily participated and provided written informed consent. Participants meeting all above criteria were enrolled.

Exclusion Criteria:

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

Primary outcomes:
measure: Fugl-Meyer Upper Extremity Scale
timeFrame: 4 weeks (post-intervention)
Secondary outcomes:
measure: Wolf Motor Function Test
timeFrame: 4 weeks
measure: Shoulder Range of Motion
timeFrame: 4 weeks
measure: Upper Limb Muscle Strength Assessment
timeFrame: 4 weeks
measure: Trunk Impairment Scale
timeFrame: 4 weeks
measure: Modified Barthel Index
timeFrame: 4 weeks
measure: Stroke-Specific Quality of Life Scale
timeFrame: 4 weeks
Other outcomes:
measure: Upper Limb Muscle Synergy Patterns
timeFrame: 4 weeks
measure: Kinematic Analysis of Upper Limb Movements During Functional Motor Tasks
timeFrame: 4 weeks
measure: Multimodal Neuroimaging Analysis
timeFrame: 4 weeks
measure: Exercise-associated Blood Biomarkers
timeFrame: 4 weeks
Locations:
city: Fuzhou
country: China
facility: Fujian University of Traditional Chinese Medicine
state: Fujian
Study officials:
References: