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CUHK Jockey Club HOPE 4 Care Programme - Hand of Hope

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
EMG-driven
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • at least six months after the onset of a unilateral ischemic brain injury or intracerebral haemorrhage
  • upper-limb motor impairments due to stroke
  • metacarpophalangeal and proximal interphalangeal joints of fingers can be extended to 180 degree passively
  • spasticity during extension at the finger joints is lower than 3 as measured by the Modified Ashworth Scale
  • detectable voluntary EMG signals from the flexor digitorum and extensor digitorum muscles of the paretic hand
  • have sufficient cognition to follow the experimental instructions

Exclusion Criteria:

  • have other neurological, neuromuscular, and orthopedic diseases
  • have shoulder or arm contracture/pain

Sites / Locations

  • Department of Biomedical Engineering, The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EMG-driven

Arm Description

The hand training system functions as a biofeedback device which surface electromyography (EMG) sensors are used to capture the user's own muscle signals to activate the system for moving his/her paretic hand.

Outcomes

Primary Outcome Measures

Action Research Arm Test (ARAT)
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Wolf Motor Function Test (WMFT)

Secondary Outcome Measures

Modified Ashworth Scale (MAS)

Full Information

First Posted
December 20, 2018
Last Updated
October 19, 2022
Sponsor
Chinese University of Hong Kong
Collaborators
The Hong Kong Jockey Club Charities Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03808415
Brief Title
CUHK Jockey Club HOPE 4 Care Programme - Hand of Hope
Official Title
Jockey Club Tech-based Stroke Rehabilitation Programme - Hand of Hope
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

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 interactive intention-driven hand training robotic system is used for neuromuscular rehabilitation of the hand and forearm. This can help stroke survivors to regain their hand functions through motor relearning.

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
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMG-driven
Arm Type
Experimental
Arm Description
The hand training system functions as a biofeedback device which surface electromyography (EMG) sensors are used to capture the user's own muscle signals to activate the system for moving his/her paretic hand.
Intervention Type
Device
Intervention Name(s)
EMG-driven
Intervention Description
The EMG signals are processed and can be visualized with visual feedback to make sure the user actively engaging throughout a therapy session.
Primary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Time Frame
3-month follow-up
Title
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Time Frame
3-month follow-up
Title
Wolf Motor Function Test (WMFT)
Time Frame
3-month follow-up
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale (MAS)
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: at least six months after the onset of a unilateral ischemic brain injury or intracerebral haemorrhage upper-limb motor impairments due to stroke metacarpophalangeal and proximal interphalangeal joints of fingers can be extended to 180 degree passively spasticity during extension at the finger joints is lower than 3 as measured by the Modified Ashworth Scale detectable voluntary EMG signals from the flexor digitorum and extensor digitorum muscles of the paretic hand have sufficient cognition to follow the experimental instructions Exclusion Criteria: have other neurological, neuromuscular, and orthopedic diseases have shoulder or arm contracture/pain
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CUHK Jockey Club HOPE 4 Care Programme - Hand of Hope

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