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

Jing Tao

Status: Enrolling

Conditions: Stroke

Treatments: Device: Robot-Assisted Tai Chi Training; Behavioral: Conventional rehabilitation training

Study type: Interventional

Funder types: Other

Identifiers

NCT06897631

FujianUTCM-4

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with stroke confirmed by neuroimaging (CT/MRI).
2. Fugl-Meyer Assessment for Upper Extremity score of 8-44.
3. First-ever stroke, with unilateral hemiplegia and time since onset ≤12 months.
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. Pre-existing neuromuscular disorders, active malignancies, or uncontrolled systemic diseases (cardiac, renal, hepatic).
9. Concurrent participation in other clinical trials affecting study outcomes. Participants meeting any of the above criteria were excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Tai Chi-based rehabilitation robot group

Experimental group

Treatment:

Device: Robot-Assisted Tai Chi Training

Conventional rehabilitation group

Experimental group

Treatment:

Behavioral: Conventional rehabilitation training