ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Hong Kong Polytechnic University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ENMS-BSF assisted gait training
Device1. 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: ENMS-BSF assisted gait trainingExperimental treatment 1 intervention
Group B: Partial ENMS-BSF assisted gait trainingActive comparator 1 intervention
Group C: Sham ENMS-BSF assisted gait trainingSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Fugl-Meyer Assessment
To evaluate the voluntary motor function of the lower limb after the interventions
Time frame
before, one day after, and 3 months after the trainingSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hong Kong Polytechnic University
Lead sponsor
Innovation and Technology Commission, Hong Kong
Collaborator
Prince of Wales Hospital, Shatin, Hong Kong
Collaborator
Source ClinicalTrials.gov