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Recruiting NCT06897631

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

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robot-Assisted Tai Chi Training, Conventional rehabilitation training.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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
  • 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 p

Primary outcome measures

  • Fugl-Meyer Upper Extremity Scale [Time frame: 4 weeks (post-intervention)]
Secondary outcome measures (6)
  • Wolf Motor Function Test [Time frame: 4 weeks]
  • Shoulder Range of Motion [Time frame: 4 weeks]
  • Upper Limb Muscle Strength Assessment [Time frame: 4 weeks]
  • Trunk Impairment Scale [Time frame: 4 weeks]
  • Modified Barthel Index [Time frame: 4 weeks]
  • Stroke-Specific Quality of Life Scale [Time frame: 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine — Fuzhou
  • The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicin — Fuzhou

Identifiers

NCT: NCT06897631 · FujianUTCM-4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗