Robotic arm for upper limb rehabilitation after stroke
Mobile Electromyography (EMG)-Driven Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke
This study is testing a new robotic arm to see if it can help stroke patients recover their arm movement better than regular therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT03752775 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new robotic arm designed for multi-joint coordinated rehabilitation of the upper limb in stroke patients. The mobile exo-neuro-musculo-skeleton integrates features of exoskeletons, soft robotics, and neuromuscular electrical stimulation to provide a noninvasive and comfortable rehabilitation experience. Patients with both subacute and chronic strokes will participate, receiving device-assisted therapy compared to conventional rehabilitation methods. The effectiveness of this innovative approach will be assessed through pre- and post-treatment clinical evaluations.
Who should consider this trial
Good fit: Ideal candidates include individuals who have experienced a stroke within the last six months and have specific motor function limitations.
Not a fit: Patients who are currently pregnant, have language deficiencies, or do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve motor function in stroke patients, enhancing their rehabilitation outcomes.
How similar studies have performed: Other studies have shown promise with robotic-assisted rehabilitation approaches, suggesting potential success for this novel device.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For the subacute groups: * Two weeks after the onset of stroke, however less than 0.5 year * Mini-Mental State Examination (MMSE)\>21 * Able to sit up for at least 1 hour * Fugl-Meyer Assessment (FMA) upper limb \<30 * Modified Ashworth Score (MAS) at the elbow, wrist and fingers \<3 * Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline) For the chronic device assisted group: * At least 0.5 year after the onset of stroke * Mini-Mental State Examination (MMSE)\>21 * Able to sit up for at least 1 hour * Fugl-Meyer Assessment (FMA) upper limb \<30 * Modified Ashworth Score (MAS) at the elbow, wrist and fingers \<3 * Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline) Exclusion Criteria: Subjects will be excluded if they do not meet the above inclusion criteria, or had the following conditions: * Currently pregnant * Dysphasia (language deficiency) * Post-stroke neglect * Pacemaker implantation, * Involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb * The overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).
Where this trial is running
Hong Kong
- The Hong Kong Polytechnic University — Hong Kong, China (Recruiting)
Study contacts
- Study coordinator: Xiaoling Hu, PhD
- Email: xiaoling.hu@polyu.edu.hk
- Phone: 34003206
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.