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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06897631
Enrollment
120
Registered
2025-03-27
Start date
2025-04-29
Completion date
2026-12-31
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, upper limb, robot, tai chi, motor function

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.

Interventions

DEVICERobot-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 per week over 4 weeks, with robotic assistance tailored to guide functional upper limb trajectories while minimizing compensatory movements.

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 proper movement patterns and safety.

Sponsors

Jing Tao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Upper Extremity Scale4 weeks (post-intervention)Score range 0-66, higher scores indicate better upper limb motor recovery.

Secondary

MeasureTime frameDescription
Wolf Motor Function Test4 weeksThe Wolf Motor Function Test (WMFT) evaluates upper limb motor function in conditions like stroke through 15 timed functional tasks (e.g., lifting objects) and 2 strength tasks. It scores Performance Time (total seconds; lower = faster) and Functional Ability (0-5 per task, max 75; higher = better movement quality), with improved motor recovery indicated by reduced time and increased ability scores.
Shoulder Range of Motion4 weeksShoulder active (AROM) and passive (PROM) range of motion were assessed in flexion, abduction, and rotation using a standardized protocol.
Upper Limb Muscle Strength Assessment4 weeksMuscle strength is assessed using Manual Muscle Testing (MMT) graded via the Medical Research Council (MRC) Scale (range: 0-5, where 0 = no muscle contraction and 5 = normal strength, higher scores indicate better outcomes).
Trunk Impairment Scale4 weeksThe 17-item Trunk Impairment Scale (TIS) comprises three subscales: static sitting balance (3 items), dynamic sitting balance (10 items), and coordination (4 items). Each item is scored on a 2-, 3- or 4-point ordinal scale from 0 to 3, with the maximal scores for the static and dynamic sitting balance and coordination subscales that can be attained being 7, 10 and 6. The total scores for the TIS range from 0 to 23, representing the lowest to the highest level of body balancing function.
Modified Barthel Index4 weeksScore range 0-100, higher scores indicate better independence in activities of daily living.
Stroke-Specific Quality of Life Scale4 weeksScore range 49-245, higher scores indicate better health-related quality of life in stroke survivors.

Countries

China

Contacts

CONTACTJingsong Wu
jingsongwu01@163.com13609501214

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026