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

NCT04934787 | Recruiting

• 1 other identifier: ITS/062/19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Stroke; Foot Drop; Foot Inversion Deformity

Keywords

Robot; Stroke; Lower limb

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment

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

  before, one day after, and 3 months after the training

Study Arms (3)

ENMS-BSF assisted gait training

EXPERIMENTAL

The participants will receive the full assistance of the ENMS-BSF during a 20-session gait rehabilitation.

Device: ENMS-BSF assisted gait training

Partial ENMS-BSF assisted gait training

ACTIVE COMPARATOR

The participants will receive a partial assistance of the ENMS-BSF during a 20-session gait rehabilitation.

Device: ENMS-BSF assisted gait training

Sham ENMS-BSF assisted gait training

SHAM COMPARATOR

The participants will only wear the device without assistance during a 20-session gait rehabilitation.

Device: ENMS-BSF assisted gait training

Interventions

ENMS-BSF assisted gait training DEVICE

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.

ENMS-BSF assisted gait training; Partial ENMS-BSF assisted gait training; Sham ENMS-BSF assisted gait training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Receiving other lower limb rehabilitative interventions at the same time

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Innovation and Technology Commission, Hong Kong: collaborator
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Stroke; Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases

Central Study Contacts

Xiaoling Hu, PhD

CONTACT

34003206; xiaoling.hu@polyu.edu.hk

Cherrie Mok

CONTACT

cherrie.mok@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Profession

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 22, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)