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

Primary Purpose

Cerebrovascular Stroke, Foot Drop, Foot Inversion Deformity

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ENMS-BSF assisted gait training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Stroke focused on measuring Robot, Stroke, Lower limb

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

ENMS-BSF assisted gait training

Partial ENMS-BSF assisted gait training

Sham ENMS-BSF assisted gait training

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer Assessment
To evaluate the voluntary motor function of the lower limb after the interventions

Secondary Outcome Measures

Full Information

First Posted
June 3, 2021
Last Updated
August 23, 2022
Sponsor
The Hong Kong Polytechnic University
Collaborators
Innovation and Technology Commission, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04934787
Brief Title
ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
Official Title
Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Innovation and Technology Commission, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Stroke, Foot Drop, Foot Inversion Deformity
Keywords
Robot, Stroke, Lower limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ENMS-BSF assisted gait training
Arm Type
Experimental
Arm Description
The participants will receive the full assistance of the ENMS-BSF during a 20-session gait rehabilitation.
Arm Title
Partial ENMS-BSF assisted gait training
Arm Type
Active Comparator
Arm Description
The participants will receive a partial assistance of the ENMS-BSF during a 20-session gait rehabilitation.
Arm Title
Sham ENMS-BSF assisted gait training
Arm Type
Sham Comparator
Arm Description
The participants will only wear the device without assistance during a 20-session gait rehabilitation.
Intervention Type
Device
Intervention Name(s)
ENMS-BSF assisted gait training
Intervention Description
ENMS-BSF will correct the foot-drop and foot inversion during post-stroke walking. Each participant will receive 20 sessions device assisted training, with an intensity of 3-5 sessions/week, 1 hr/session. 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.
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment
Description
To evaluate the voluntary motor function of the lower limb after the interventions
Time Frame
before, one day after, and 3 months after the training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoling Hu, PhD
Phone
34003206
Email
xiaoling.hu@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Cherrie Mok
Email
cherrie.mok@polyu.edu.hk
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoling Hu, Ph.D.
Phone
+852 34003205
Email
xiaoling.hu@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Xiaoling Hu, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
According to the obtained ethical approval, all personal data of participants cannot be shared or released.

Learn more about this trial

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

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