Ankle-foot rehabilitation using a robotic device for stroke patients
Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke
This study is testing a new robotic device to help stroke survivors improve their walking and regain better movement in their ankles and feet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04934787 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel hybrid ankle-foot robot designed to assist in gait rehabilitation for individuals recovering from stroke. The device, known as the exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF), integrates soft pneumatic muscles, functional electrical stimulation, and exoskeleton technology to improve muscle coordination and correct foot drop and inversion. Participants will engage in gait training with this wearable device, which aims to enhance their walking patterns and provide long-term rehabilitative benefits. The study focuses on individuals who have experienced a stroke at least six months prior and have mild to moderate motor impairments.
Who should consider this trial
Good fit: Ideal candidates are stroke survivors at least six months post-event with mild to moderate motor impairment in the affected lower limb.
Not a fit: Patients with severe spasticity at the ankle joint or those receiving concurrent lower limb rehabilitation interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve walking ability and quality of life for stroke survivors with foot drop.
How similar studies have performed: While the approach is innovative, similar robotic-assisted rehabilitation methods have shown promise in improving mobility in stroke patients, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 6 months after the onset of stroke * Have sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score \>21). * Have mild-to-moderate motor impairment in the affected lower limb with foot drop but be capable of standing and walking without manual assistance. * Fugl-Meyer Assessment (FMA), total score on the lower limb \<20 * Functional Ambulatory Category (FAC) ≥4 * Berg Balance Scale (BBS) ≥40 Exclusion Criteria: * The exclusion criteria will be server spasticity at the ankle joint measured by Modified Ashworth Score (MAS) \>3. * Receiving other lower limb rehabilitative interventions at the same time
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.