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

Not Applicable

Recruiting

• Conditions: Cerebrovascular Stroke; Foot Drop; Foot Inversion Deformity
• Interventions: Device: ENMS-BSF assisted gait training

• Registration Number: NCT04934787
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-22
• Study Start: 2021-07-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partial ENMS-BSF assisted gait training	ENMS-BSF assisted gait training	The participants will receive a partial assistance of the ENMS-BSF during a 20-session gait rehabilitation.
ENMS-BSF assisted gait training	ENMS-BSF assisted gait training	The participants will receive the full assistance of the ENMS-BSF during a 20-session gait rehabilitation.
Sham ENMS-BSF assisted gait training	ENMS-BSF assisted gait training	The participants will only wear the device without assistance during a 20-session gait rehabilitation.

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer Assessment	before, one day after, and 3 months after the training	To evaluate the voluntary motor function of the lower limb after the interventions

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇨🇳 Hong Kong, China