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A multicenter clinical study on the improvement of motor dysfunction in stroke patients with upper limb rehabilitation robot based on Tai Chi movement optimization

A multicenter clinical study on the improvement of motor dysfunction in stroke patients with upper limb rehabilitation robot based on Tai Chi movement optimization

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123368
Enrollment
Unknown
Registered
2026-04-26
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke

Interventions

Tai Chi Robot Training Group (Trial Group):Conventional rehabilitation training + upper limb rehabilitation robot (Estun unilateral upper limb intelligent feedback rehabilitation robot EM-BURTO2-01B)
Robot-Assisted Game Training Group (Control Group):Conventional rehabilitation training + upper limb rehabilitation robot (Estun unilateral upper limb intelligent feedback rehabilitation robot EM-BURT

Sponsors

Zhongda Hospital Affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for stroke and is confirmed by cranial CT or MRI 2. aged 18-80 years, regardless of gender 3. first-ever stroke, with a disease duration of 2 weeks to 6 months 4. presence of moderate to severe upper limb motor impairment, defined as a Fugl-Meyer Upper Extremity Assessment score of 8-38 5. able to understand and cooperate with the upper limb rehabilitation robot training used in this study, and able to maintain independent sitting for at least 45 minutes 6. willing to participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with dementia or psychiatric disorders, as excluded by a neurologist according to the diagnostic criteria of the International Classification of Diseases, 10th Revision (ICD-10) issued by the World Health Organization and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 2. Patients with severe internal medical diseases, unstable vital signs, or inability to complete the task activities required in this study; 3. Patients with fractures of the hemiplegic limb, severe infection, severe hepatic or renal dysfunction, or other serious comorbid conditions; 4. Patients with contractures of the shoulder, elbow, or wrist joints caused by trauma, fracture, or joint spasticity; 5. Patients currently participating in other clinical studies that may affect the results of this study.

Design outcomes

Primary

MeasureTime frame
Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score (Post-intervention minus Pre-intervention);

Secondary

MeasureTime frame
Wolf Motor Function Test Time (WFMT-Time);Wolf Motor Function Test Functional Ability Score (WFMT-FAS);Modified Barthel Index (MBI);Stroke-Specific Quality of Life Scale (SS-QOL);Cortical Hemodynamic Changes;Electromyographic Signals from Key Muscles;

Countries

China

Contacts

Public ContactWan Ruihan

Zhongda Hospital Affiliated to Southeast University

wanruih@163.com+86 187 5124 2707

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026