NCT04934787 ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
| NCT ID | NCT04934787 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Cerebrovascular Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-07-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this work, a novel hybrid ankle-foot robot is designed for gait rehabilitation after stroke, i.e., exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF) by integrating the advantages of soft pneumatic muscle, functional electrical stimulation, exoskeleton and foot balance feedback in one system. With the assistance of the ENMS-BSF the foot drop and foot inversion could be corrected with improved muscle coordination in the paretic lower limb. The device is wearable and light-in-weight for unilateral application during walking. It is hypothesized that with the intervention of the ENMS-BSF the gait pattern of persons after stroke can be improved with long-term rehabilitative effects.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04934787 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Cerebrovascular Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04934787 currently recruiting?
Yes, NCT04934787 is actively recruiting participants. Contact the research team at xiaoling.hu@polyu.edu.hk for enrollment information.
Where is the NCT04934787 trial being conducted?
This trial is being conducted at Hong Kong, China.
Who is sponsoring the NCT04934787 clinical trial?
NCT04934787 is sponsored by The Hong Kong Polytechnic University. The trial plans to enroll 60 participants.
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