Robot-assisted training for improving upper limb function after stroke
Motor-Cognitive Interactive Upper Limb Rehabilitation Robot Intervention for Post-Stroke Motor Dysfunction: A Multicenter Randomized Controlled Study
This study tests whether robot-assisted training that combines movement and thinking exercises can help people recover better use of their arms after a stroke compared to other types of therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1047 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Fujian University of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Fuzhou) |
| Trial ID | NCT06876597 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of motor-cognitive interactive robot-assisted training on upper limb motor dysfunction following a stroke. Participants will be randomly assigned to one of three groups: motor-cognitive interactive training, motor-focused training, or conventional rehabilitation. The training sessions will last 60 minutes, five times a week for four weeks, with researchers measuring changes in upper limb function and monitoring for adverse events. The study aims to optimize rehabilitation protocols by clarifying the relationship between motor and cognitive training components.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 80 who have experienced their first stroke with unilateral limb paralysis within the last 2 to 6 months.
Not a fit: Patients with severe comorbid conditions, significant balance issues, or severe depressive symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery of upper limb function in stroke patients.
How similar studies have performed: Other studies have shown promise in using robotic assistance for rehabilitation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of stroke confirmed by CT or MRI. 2. Age between 40 and 80 years, with no gender restrictions. 3. First-ever stroke with unilateral limb paralysis. 4. Onset of stroke between 2 weeks and 6 months prior, with an FMA-UE score of 8-44. 5. Willingness to participate and provide written informed consent. Exclusion Criteria: 1. History of neuromuscular diseases, malignant tumors, or other severe uncontrolled conditions, including cardiac, renal, or hepatic diseases. 2. Seated balance score \< 2, or inability to maintain a sitting position for more than 60 minutes. 3. Modified Ashworth Scale score \> 2. 4. Visual Analog Scale (VAS) score \> 3 for hemiplegic shoulder pain. 5. Boston Diagnostic Aphasia Examination score \< 3. 6. Severe visual impairment preventing participation in upper limb robot-assisted rehabilitation training. 7. Hamilton Depression Scale score \>17, indicating moderate to severe depressive symptoms. 8. Participation in other clinical trials that may interfere with the results of this study.
Where this trial is running
Fuzhou
- Fujian University of Traditional Chinese Medicine — Fuzhou, China (Recruiting)
Study contacts
- Study coordinator: Jingsong Wu
- Email: jingsongwu01@163.com
- Phone: 86+13609501214
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.