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

April 4, 2025 updated by: Xiaoling Hu, The Hong Kong Polytechnic University

Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • The Hong Kong Polytechnic University
        • Contact:
        • Principal Investigator:
          • Xiaoling Hu, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ENMS-BSF assisted gait training
The participants will receive the full assistance of the ENMS-BSF during a 20-session gait rehabilitation.
Device: 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.
Active Comparator: Partial ENMS-BSF assisted gait training
The participants will receive a partial assistance of the ENMS-BSF during a 20-session gait rehabilitation.
Device: 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.
Sham Comparator: Sham ENMS-BSF assisted gait training
The participants will only wear the device without assistance during a 20-session gait rehabilitation.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer Assessment
Time Frame: before, one day after, and 3 months after the training
To evaluate the voluntary motor function of the lower limb after the interventions
before, one day after, and 3 months after the training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Prince of Wales Hospital, Shatin, Hong Kong
Innovation and Technology Commission, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITS/062/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

According to the obtained ethical approval, all personal data of participants cannot be shared or released.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Foot Drop

Clinical Trials on ENMS-BSF assisted gait training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe