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

Study Overview
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Brief Summary
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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.

Official Title
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Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke

Conditions
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Cerebrovascular Stroke, Foot Drop, Foot Inversion Deformity

Intervention / Treatment
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* Device: ENMS-BSF assisted gait training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENMS-BSF assisted gait training<br>The participants will receive the full assistance of the ENMS-BSF during a 20-session gait rehabilitation. | Device: ENMS-BSF assisted gait training<br>* ENMS-BSF will correct the foot-drop and foot inversion during post-stroke walking. Each participant will receive 20 sessions device assisted training, with an intensity of 3-5 sessions/week, 1 hr/session. In each session, a participant will complete the device-assisted walking on flat ground with a natural speed and with the aid of a four-pronged cane.<br>|
| Active Comparator: Partial ENMS-BSF assisted gait training<br>The participants will receive a partial assistance of the ENMS-BSF during a 20-session gait rehabilitation. | Device: ENMS-BSF assisted gait training<br>* ENMS-BSF will correct the foot-drop and foot inversion during post-stroke walking. Each participant will receive 20 sessions device assisted training, with an intensity of 3-5 sessions/week, 1 hr/session. In each session, a participant will complete the device-assisted walking on flat ground with a natural speed and with the aid of a four-pronged cane.<br>|
| Sham Comparator: Sham ENMS-BSF assisted gait training<br>The participants will only wear the device without assistance during a 20-session gait rehabilitation. | Device: ENMS-BSF assisted gait training<br>* ENMS-BSF will correct the foot-drop and foot inversion during post-stroke walking. Each participant will receive 20 sessions device assisted training, with an intensity of 3-5 sessions/week, 1 hr/session. In each session, a participant will complete the device-assisted walking on flat ground with a natural speed and with the aid of a four-pronged cane.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fugl-Meyer Assessment | To evaluate the voluntary motor function of the lower limb after the interventions | before, one day after, and 3 months after the training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robot, Stroke, Lower limb