Back to resultsCUHK Jockey Club HOPE 4 Care Programme - Ankle Robot
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Ankle Group
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- have the ability to walk on the ground independently or with one personal assistance with or without walking aids
- able to understand simple commends
Exclusion Criteria:
- have other neurological, neuromuscular, and orthopedic diseases
- uncontrolled cardiovascular or respiratory disorders
- moderate to severe contractures in the lower extremities
Sites / Locations
- Department of Biomedical Engineering, The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ankle Group
Arm Description
Integrated with force and motion sensors to identify gait phase and classify user walking intention using machine learning control algorithm.
Outcomes
Primary Outcome Measures
Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Secondary Outcome Measures
Functional Ambulation Classification (FAC)
Modified Ashworth Scale (MAS)
Berg Balance Scale (BBS)
Timed 10-Meter Walk Test (10MWT)
6 Minute Walk Test (6MWT)
Full Information
NCT ID
NCT03808428
First Posted
December 20, 2018
Last Updated
January 15, 2019
Sponsor
Chinese University of Hong Kong
Collaborators
The Hong Kong Jockey Club Charities Trust
1. Study Identification
Unique Protocol Identification Number
NCT03808428
Brief Title
CUHK Jockey Club HOPE 4 Care Programme - Ankle Robot
Official Title
CUHK Jockey Club Tech-Based Stroke Rehabilitation Programme for Elderly Centre - Interactive Exoskeleton Ankle Robot
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
The Hong Kong Jockey Club Charities Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project 'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community. The Exoskeleton Ankle Robot is a robot-assisted Ankle-Foot-Orthosis to facilitate gait training of person after stroke with drop foot.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ankle Group
Arm Type
Experimental
Arm Description
Integrated with force and motion sensors to identify gait phase and classify user walking intention using machine learning control algorithm.
Intervention Type
Device
Intervention Name(s)
Ankle Group
Intervention Description
Provide sensory feedback to help subjects relearn how to walk in correct gait pattern.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Time Frame
3-month follow-up
Secondary Outcome Measure Information:
Title
Functional Ambulation Classification (FAC)
Time Frame
3-month follow-up
Title
Modified Ashworth Scale (MAS)
Time Frame
3-month follow-up
Title
Berg Balance Scale (BBS)
Time Frame
3-month follow-up
Title
Timed 10-Meter Walk Test (10MWT)
Time Frame
3-month follow-up
Title
6 Minute Walk Test (6MWT)
Time Frame
3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
have the ability to walk on the ground independently or with one personal assistance with or without walking aids
able to understand simple commends
Exclusion Criteria:
have other neurological, neuromuscular, and orthopedic diseases
uncontrolled cardiovascular or respiratory disorders
moderate to severe contractures in the lower extremities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Tong, PhD
Phone
+85239438454
Email
kytong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Organizational Affiliation
Department of Biomedical Engineering, CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biomedical Engineering, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Phone
+852 3943 8454
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CUHK Jockey Club HOPE 4 Care Programme - Ankle Robot
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