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

NCT ID: NCT04934787

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Cerebrovascular Stroke Foot Drop Foot Inversion Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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ENMS-BSF assisted gait training

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

Group Type EXPERIMENTAL

ENMS-BSF assisted gait training

Intervention Type 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.

Partial ENMS-BSF assisted gait training

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

Group Type ACTIVE_COMPARATOR

ENMS-BSF assisted gait training

Intervention Type 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.

Sham ENMS-BSF assisted gait training

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

Group Type SHAM_COMPARATOR

ENMS-BSF assisted gait training

Intervention Type 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.

Interventions

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ENMS-BSF assisted gait training

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.

Intervention Type DEVICE

Eligibility Criteria

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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

* Receiving other lower limb rehabilitative interventions at the same time
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovation and Technology Commission, Hong Kong

OTHER

Sponsor Role collaborator

Prince of Wales Hospital, Shatin, Hong Kong

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Xiaoling Hu

Assistant Profession

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Hong Kong Polytechnic University

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoling Hu, PhD

Role: CONTACT

Cherrie Mok

Role: CONTACT

Facility Contacts

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Xiaoling Hu, Ph.D.

Role: primary

+852 34003205

Other Identifiers

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ITS/062/19

Identifier Type: -

Identifier Source: org_study_id

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