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

NCT ID: NCT06897631

Last Updated: 2026-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-29

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tai Chi-based rehabilitation robot group

Group Type EXPERIMENTAL

Robot-Assisted Tai Chi Training

Intervention Type 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.

Conventional rehabilitation group

Group Type EXPERIMENTAL

Conventional rehabilitation training

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jing Tao

OTHER

Sponsor Role lead

Responsible Party

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Jing Tao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, China

Site Status RECRUITING

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

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jingsong Wu

Role: CONTACT

13609501214

Facility Contacts

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Jingsong Wu

Role: primary

86+13609501214

Jingsong Wu

Role: primary

86+13609501214

Other Identifiers

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FujianUTCM-4

Identifier Type: -

Identifier Source: org_study_id

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