ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ENMS-BSF assisted gait training.
- Who it may be relevant to
- Registry conditions: Cerebrovascular Stroke, Foot Drop, Foot Inversion Deformity. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke
Overview
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.
Interventions
- Device ENMS-BSF assisted gait training
1. ENMS-BSF will correct the foot-drop and foot inversion during post-stroke walking. 2. Each participant will receive 20 sessions device assisted training, with an intensity of 3-5 sessions/week, 1 hr/session. 3. 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.
Primary outcome measures
- Change in Fugl-Meyer Assessment [Time frame: before, one day after, and 3 months after the training]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Hong Kong Polytechnic University — Hong Kong
Identifiers
NCT: NCT04934787 · ITS/062/19