- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03808428
CUHK Jockey Club HOPE 4 Care Programme - Ankle Robot
January 15, 2019 updated by: Raymond KY Tong, Chinese University of Hong Kong
CUHK Jockey Club Tech-Based Stroke Rehabilitation Programme for Elderly Centre - Interactive Exoskeleton Ankle Robot
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
120
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
- Name: Raymond Tong, PhD
- Phone Number: +85239438454
- Email: kytong@cuhk.edu.hk
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- Department of Biomedical Engineering, The Chinese University of Hong Kong
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Contact:
- Raymond Tong, PhD
- Phone Number: +852 3943 8454
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ankle Group
Integrated with force and motion sensors to identify gait phase and classify user walking intention using machine learning control algorithm.
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Provide sensory feedback to help subjects relearn how to walk in correct gait pattern.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Time Frame: 3-month follow-up
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3-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modified Ashworth Scale (MAS)
Time Frame: 3-month follow-up
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3-month follow-up
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Functional Ambulation Classification (FAC)
Time Frame: 3-month follow-up
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3-month follow-up
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Berg Balance Scale (BBS)
Time Frame: 3-month follow-up
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3-month follow-up
|
Timed 10-Meter Walk Test (10MWT)
Time Frame: 3-month follow-up
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3-month follow-up
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6 Minute Walk Test (6MWT)
Time Frame: 3-month follow-up
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3-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Anticipated)
February 1, 2019
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
December 20, 2018
First Submitted That Met QC Criteria
January 15, 2019
First Posted (Actual)
January 17, 2019
Study Record Updates
Last Update Posted (Actual)
January 17, 2019
Last Update Submitted That Met QC Criteria
January 15, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018.493
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
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Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
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Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
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IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
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Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
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University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
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University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
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Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
Clinical Trials on Ankle Group
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University of Maryland, BaltimoreRecruiting
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Abant Izzet Baysal UniversityNot yet recruitingDiabetes Mellitus, Type 2
-
University of Sao Paulo General HospitalCompletedDiabetic NeuropathiesBrazil
-
Universidade Federal de Sao CarlosUniversity of Sao PauloSuspendedKnee OsteoarthritisBrazil
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Seattle Institute for Biomedical and Clinical ResearchNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsActive, not recruitingOsteoarthritis (OA) | End-stage Ankle Arthritis (ESAA)United States
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Synchro Motion LLCShirley Ryan AbilityLabRecruiting
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Assiut UniversityNot yet recruitingAnkle Injuries | Ankle Fractures | Arthroscopic Surgery
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Zimmer BiometActive, not recruitingRheumatoid Arthritis | Degenerative Arthritis | Post Traumatic ArthritisUnited States, Switzerland, Canada, Finland, Germany, Italy
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Spaarne GasthuisCompletedAnkle Injuries | Acute Ankle Sprain | Ankle Ligament RuptureNetherlands
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Barbara ŁysońCompleted