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Recruiting NCT04934787

ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation

Trial Parameters

Condition Cerebrovascular Stroke
Sponsor The Hong Kong Polytechnic University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2021-07-01
Completion 2025-12
Interventions
ENMS-BSF assisted gait training

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

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