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Clinical Trials/NCT04934787
NCT04934787
Recruiting
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country60 target enrollmentJuly 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebrovascular Stroke
Sponsor
The Hong Kong Polytechnic University
Enrollment
60
Locations
1
Primary Endpoint
Change in Fugl-Meyer Assessment
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiaoling Hu

Assistant Profession

The Hong Kong Polytechnic University

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) \>
  • Receiving other lower limb rehabilitative interventions at the same time

Outcomes

Primary Outcomes

Change in Fugl-Meyer Assessment

Time Frame: before, one day after, and 3 months after the training

To evaluate the voluntary motor function of the lower limb after the interventions

Study Sites (1)

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