Actively Recruiting
Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke
Led by The Hong Kong Polytechnic University · Updated on 2025-04-08
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Hong Kong Polytechnic University
Lead Sponsor
I
Innovation and Technology Commission, Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new hybrid ankle-foot robot called the exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF) to assist gait rehabilitation after stroke. This device combines soft pneumatic muscle, electrical stimulation, exoskeleton support, and foot balance feedback to help correct foot drop and foot inversion deformity. The study aims to improve muscle coordination and gait patterns in people who have had a stroke, with expected long-term rehabilitation benefits. Participants are randomly assigned to one of three groups: full assistance with the ENMS-BSF device during gait training, partial assistance during gait training, or wearing the device without assistance. Each participant will undergo 20 training sessions, with 3 to 5 sessions per week, each lasting one hour. During each session, participants will walk naturally on flat ground with a four-pronged cane while receiving the assigned level of device assistance. Throughout the study, participants will be assessed using the Fugl-Meyer Assessment before the training, one day after, and three months after completing the sessions to measure motor function improvement. The study includes monitoring balance and walking ability, and participants must meet specific cognitive and motor function criteria to take part. The total study duration includes the training period and follow-up assessments to observe lasting effects.
CONDITIONS
Brief Title
ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 6 months after the onset of stroke
- Sufficient cognition to follow simple instructions and understand the study (MMSE score >21)
- Mild-to-moderate motor impairment in the affected lower limb with foot drop
- Capable of standing and walking without manual assistance
- Fugl-Meyer Assessment lower limb total score less than 20
- Functional Ambulatory Category score 4 or higher
- Berg Balance Scale score 40 or higher
You will not qualify if you...
- Severe spasticity at the ankle joint (Modified Ashworth Score greater than 3)
- Receiving other lower limb rehabilitative interventions at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 4 to 7 weeks
Participants undergo 20 sessions of device-assisted gait training with the ENMS-BSF device to help correct foot-drop and foot inversion during post-stroke walking.
3 to 5 sessions per week, 1 hour per session
Trial Site Locations
Total: 1 location
1
The Hong Kong Polytechnic University
Hong Kong, China
Actively Recruiting
Research Team
X
Xiaoling Hu, PhD
C
Cherrie Mok
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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