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NCT Number: NCT06897631

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

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Fugl-Meyer Upper Extremity Scale

    Time frame: 4 weeks (post-intervention)

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

Secondary outcomes

  1. Wolf Motor Function Test

    Time frame: 4 weeks

    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.

  2. Shoulder Range of Motion

    Time frame: 4 weeks

    Shoulder active (AROM) and passive (PROM) range of motion were assessed in flexion, abduction, and rotation using a standardized protocol.

  3. Upper Limb Muscle Strength Assessment

    Time frame: 4 weeks

    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. Trunk Impairment Scale

    Time frame: 4 weeks

    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.

  5. Modified Barthel Index

    Time frame: 4 weeks

    Score range 0-100, higher scores indicate better independence in activities of daily living.

  6. Stroke-Specific Quality of Life Scale

    Time frame: 4 weeks

    Score range 49-245, higher scores indicate better health-related quality of life in stroke survivors.

Other outcomes

  1. Upper Limb Muscle Synergy Patterns

    Time frame: 4 weeks

    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).

  2. Kinematic Analysis of Upper Limb Movements During Functional Motor Tasks

    Time frame: 4 weeks

    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.

  3. Multimodal Neuroimaging Analysis

    Time frame: 4 weeks

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jingsong Wu

CONTACT

[email protected]

13609501214

Sponsors and collaborators

Lead sponsor

Jing Tao

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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