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

NCT06897631 | Recruiting

• 1 other identifier: FujianUTCM-4
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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. 1.Robot-Assisted Tai Chi Training group: Participants will receive guided Tai Chi arm movements with robotic assistance to enhance coordination and strength.
2. 2.Conventional rehabilitation group: Participants will perform standard exercises (e.g., stretching, repetitive task practice).

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Extremity Scale

  Score range 0-66, higher scores indicate better upper limb motor recovery.

  4 weeks (post-intervention)

Secondary Outcomes (6)

• Wolf Motor Function Test

  4 weeks

• Shoulder Range of Motion

  4 weeks

• Upper Limb Muscle Strength Assessment

  4 weeks

• Trunk Impairment Scale

  4 weeks

• Modified Barthel Index

  4 weeks

Other Outcomes (3)

• Upper Limb Muscle Synergy Patterns

  4 weeks

• Kinematic Analysis of Upper Limb Movements During Functional Motor Tasks

  4 weeks

• Multimodal Neuroimaging Analysis

  4 weeks

Study Arms (2)

Tai Chi-based rehabilitation robot group

EXPERIMENTAL

Device: Robot-Assisted Tai Chi Training

Conventional rehabilitation group

EXPERIMENTAL

Behavioral: Conventional rehabilitation training

Interventions

Robot-Assisted Tai Chi Training DEVICE

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.

Tai Chi-based rehabilitation robot group

Conventional rehabilitation training BEHAVIORAL

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.

Conventional rehabilitation group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jing Tao: lead

Study Sites (2)

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, 350003, China

RECRUITING

The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, 350122, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jingsong Wu

CONTACT

13609501214; jingsongwu01@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)