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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Robot-Assisted Tai Chi Training; Behavioral: Conventional rehabilitation training

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingsong Wu; Phone Number: 13609501214; Email: jingsongwu01@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350003
      • Recruiting
      • Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine
      • Contact: Jingsong Wu; Phone Number: 86+13609501214; Email: jingsongwu01@163.com
    • Fuzhou, Fujian, China, 350122
      • Recruiting
      • The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
      • Contact: Jingsong Wu; Phone Number: 86+13609501214; Email: jingsongwu01@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tai Chi-based rehabilitation robot group	Device: 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 per week over 4 weeks, with robotic assistance tailored to guide functional upper limb trajectories while minimizing compensatory movements.
Experimental: Conventional rehabilitation group	Behavioral: 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 proper movement patterns and safety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Upper Extremity Scale	Score range 0-66, higher scores indicate better upper limb motor recovery.	4 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wolf Motor Function Test	The 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.	4 weeks
Shoulder Range of Motion	Shoulder active (AROM) and passive (PROM) range of motion were assessed in flexion, abduction, and rotation using a standardized protocol.	4 weeks
Upper Limb Muscle Strength Assessment	Muscle 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).	4 weeks
Trunk Impairment Scale	The 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.	4 weeks
Modified Barthel Index	Score range 0-100, higher scores indicate better independence in activities of daily living.	4 weeks
Stroke-Specific Quality of Life Scale	Score range 49-245, higher scores indicate better health-related quality of life in stroke survivors.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Limb Muscle Synergy Patterns	Surface electromyography (sEMG) signals were collected from upper limb muscles during drinking and forward-reaching tasks. Muscle synergy patterns underlying these functional movements were extracted and analyzed using non-negative matrix factorization (NMF).	4 weeks
Kinematic Analysis of Upper Limb Movements During Functional Motor Tasks	Upper limb kinematic data (movement trajectories and joint angles) were acquired via the OpenCap system during drinking and forward-reaching tasks. Joint moments were subsequently estimated using inverse dynamics, and task-specific motor patterns were extracted to quantify kinematic synergies and torque profiles.	4 weeks
Multimodal Neuroimaging Analysis	Structural (T1-MPRAGE) and resting-state fMRI data were acquired using a 3T MRI scanner. Structural analysis assessed gray matter volume and density, cortical thickness, and surface area, while functional analysis evaluated amplitude of low-frequency fluctuations (ALFF), regional homogeneity (ReHo), functional connectivity (FC), and graph theory-based network topology metrics (global/local efficiency).	4 weeks

Collaborators and Investigators

• Sponsor: Jing Tao

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: stroke; upper limb; robot; tai chi; motor function
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: FujianUTCM-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No