StrokeNCT06897631
Robot-Assisted Tai Chi for Upper Limb Rehabilitation in Stroke Patients
A study testing Robot-Assisted Tai Chi Training and Conventional rehabilitation training in people with Stroke, run by Jing Tao at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-Assisted Tai Chi Training and Conventional rehabilitation training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 29 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350003
Jingsong Wu, 86+13609501214, jingsongwu01@163.com
- Recruiting
The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350122
Jingsong Wu, 86+13609501214, jingsongwu01@163.com
About this study
Official title: 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:
- Robot-Assisted Tai Chi Training group: Participants will receive guided Tai Chi arm movements with robotic assistance to enhance coordination and strength.
- 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.
- Conditions
- Stroke
- Being tested
- Robot-Assisted Tai Chi Training, Conventional rehabilitation training
- Keywords
- stroke, upper limb, robot, tai chi, motor function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Tai Chi TrainingDevice
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi-based rehabilitation robot group | Experimental | Not described Receives: Device: Robot-Assisted Tai Chi Training |
| Conventional rehabilitation group | Experimental | Not described Receives: Behavioral: Conventional rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity Scale
Score range 0-66, higher scores indicate better upper limb motor recovery.
Measured: 4 weeks (post-intervention)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 4 weeks
Modified Barthel Index
Score range 0-100, higher scores indicate better independence in activities of daily living.
Measured: 4 weeks
Stroke-Specific Quality of Life Scale
Score range 49-245, higher scores indicate better health-related quality of life in stroke survivors.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start29 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Tao, Fujian University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897631
- Sponsor's protocol ID
- FujianUTCM-4
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Tai Chi for Upper Limb Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial on Motor Recovery
- ClinicalTrials.gov ID
- NCT06897631
- Acronym / sponsor ID
- FujianUTCM-4
- Conditions
- Stroke
- Keywords
- stroke, upper limb, robot, tai chi, motor function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jing TaoUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Robot-Assisted Tai Chi Training group: Participants will receive guided Tai Chi arm movements with robotic assistance to enhance coordination and strength.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi-based rehabilitation robot group | Experimental | Device: Robot-Assisted Tai Chi Training |
| Conventional rehabilitation group | Experimental | Behavioral: Conventional rehabilitation training |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-Assisted Tai Chi TrainingThis 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. | Device | Tai Chi-based rehabilitation robot group |
| Conventional rehabilitation trainingThis 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. | Behavioural | Conventional rehabilitation group |
Primary outcome
Fugl-Meyer Upper Extremity Scale
Time frame: 4 weeks (post-intervention)
Score range 0-66, higher scores indicate better upper limb motor recovery.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Tai Chi Training and Conventional rehabilitation training in people with Stroke, run by Jing Tao at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingsong Wu (13609501214, jingsongwu01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity Scale (time frame: 4 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.