Pilot Study of Motor-cable-driven System for Stroke Wrist and Forearm Rehabilitation
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Motor-cable-driven Rehabilitation Robotic System
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria: Sub-acute and chronic stroke patients (ischemic or hemorrhagic). Sufficient cognition to follow simple instructions as well as understand the content and purpose of the study. Exclusion criteria: Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication. Any additional medical or psychological condition affecting their ability to comply with the study protocol.
Sites / Locations
- Department of Biomedical Engineering, The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
motor-cable-driven system
Arm Description
Receive motor-cable-driven system
Outcomes
Primary Outcome Measures
Forearm's Assisted Range of Motion
Forearm's assisted range of motion is a measurement to identify how far the person's joints range can move in pronation-supination assisted by the motor-cable-driven system. The moving range will be recorded by the system and stored in computer
Wrist's Assisted Range of Motion
Wrist's Assisted range of motion is a measurement to identify how far the person's joints range can move in flexion/extension, and radial deviation/ulnar deviation with the assistance of motor-cable-driven system. The moving range will be recorded by the system and stored in computer.
Secondary Outcome Measures
Upper limb Fugl-Meyer Assessment (FMA)
Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject.
Motor Assessment Scale (MAS)
Introduction: Motor function that are related to wrist and forearm are measured using the Motor Assessment Scale. The Motor Assessment Scale (MAS) is a performance-based scale that was developed as a means of assessing everyday motor function in patients with stroke. In MAS, task 1 and 3 in the hand movement sub-component assessment were accessed (MAS-Hand), as the two task is the most related component to the tested movement.
Score: The total or maximum scores is 2, and minimum scores is 0. In this scale, the higher the score indicates the better the condition of the subject. The score for a healthy person is 2.
Modified Ashworth Scale
Introduction: The spasticity level of wrist is measured by using Modified Ashworth Scale. It measures resistance during passive soft-tissue stretching. This measure will only measure the wrist component, as forearm component is not included in this scale.
Scoring: The total or maximum scores for the subscale is 4 and the minimum is 0 score. Higher scores indicates the higher the tone, lower score indicates less tone. 0 score indicates normal tone and no increase in tone, while 4 scores indicate affected part rigid in flexion or extension. All the scores will be summed.
Procedure: The measuring procedure starts by holding the elbow as straight as possible at forearm pronated. Then, the patient's wrist is moved from maximum possible flexion to maximum possible extension. The test is performed up tp maximum of 3 times to avoid the influence of the effect of stretch.
Forearm's Active Range of Movement
Forearm's active range of motion is a measurement to identify how far the person's joints range can move in pronation-supination by moving with their own effort. The moving range will be recorded by the system and stored in computer.
Forearm's Passive Range of Motion
Forearm's passive range of motion is a measurement to identify how far the person's joints range can move in pronation-supination directed by a person manually. The moving range will be recorded by the system and stored in computer.
Wrist's active range of motion
Wrist's active range of motion is a measurement to identify how far the person's joints range can move in flexion/extension, and radial deviation/ulnar deviation by moving with their own effort. The moving range will be recorded by the system and stored in computer.
Wrist's Passive Range of Motion
Wrist's passive range of motion is a measurement to identify how far the person's joints range can move in flexion/extension, and radial deviation/ulnar deviation directed by a person manually. The moving range will be recorded by the system and stored in computer.
Full Information
NCT ID
NCT06062121
First Posted
August 31, 2023
Last Updated
September 25, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT06062121
Brief Title
Pilot Study of Motor-cable-driven System for Stroke Wrist and Forearm Rehabilitation
Official Title
Pilot Study of Motor-cable-driven System for Stroke Wrist and Forearm Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of 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
The research purpose is to investigate the feasibility of using a motor-cable-driven system for wrist and forearm recovery of hemiplegic subjects suffered from stroke, where assistive force would be generated from cables connected to pulleys and electrical motors. The system may use EMG signal to control the movements.
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
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
motor-cable-driven system
Arm Type
Experimental
Arm Description
Receive motor-cable-driven system
Intervention Type
Device
Intervention Name(s)
Motor-cable-driven Rehabilitation Robotic System
Intervention Description
Subjects will wear the motor-cable-driven system and receive 30 minutes (including preparation time) wrist and forearm robot-assisting exercise
Primary Outcome Measure Information:
Title
Forearm's Assisted Range of Motion
Description
Forearm's assisted range of motion is a measurement to identify how far the person's joints range can move in pronation-supination assisted by the motor-cable-driven system. The moving range will be recorded by the system and stored in computer
Time Frame
Baseline
Title
Wrist's Assisted Range of Motion
Description
Wrist's Assisted range of motion is a measurement to identify how far the person's joints range can move in flexion/extension, and radial deviation/ulnar deviation with the assistance of motor-cable-driven system. The moving range will be recorded by the system and stored in computer.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Upper limb Fugl-Meyer Assessment (FMA)
Description
Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject.
Time Frame
Baseline
Title
Motor Assessment Scale (MAS)
Description
Introduction: Motor function that are related to wrist and forearm are measured using the Motor Assessment Scale. The Motor Assessment Scale (MAS) is a performance-based scale that was developed as a means of assessing everyday motor function in patients with stroke. In MAS, task 1 and 3 in the hand movement sub-component assessment were accessed (MAS-Hand), as the two task is the most related component to the tested movement.
Score: The total or maximum scores is 2, and minimum scores is 0. In this scale, the higher the score indicates the better the condition of the subject. The score for a healthy person is 2.
Time Frame
Baseline
Title
Modified Ashworth Scale
Description
Introduction: The spasticity level of wrist is measured by using Modified Ashworth Scale. It measures resistance during passive soft-tissue stretching. This measure will only measure the wrist component, as forearm component is not included in this scale.
Scoring: The total or maximum scores for the subscale is 4 and the minimum is 0 score. Higher scores indicates the higher the tone, lower score indicates less tone. 0 score indicates normal tone and no increase in tone, while 4 scores indicate affected part rigid in flexion or extension. All the scores will be summed.
Procedure: The measuring procedure starts by holding the elbow as straight as possible at forearm pronated. Then, the patient's wrist is moved from maximum possible flexion to maximum possible extension. The test is performed up tp maximum of 3 times to avoid the influence of the effect of stretch.
Time Frame
Baseline
Title
Forearm's Active Range of Movement
Description
Forearm's active range of motion is a measurement to identify how far the person's joints range can move in pronation-supination by moving with their own effort. The moving range will be recorded by the system and stored in computer.
Time Frame
Baseline
Title
Forearm's Passive Range of Motion
Description
Forearm's passive range of motion is a measurement to identify how far the person's joints range can move in pronation-supination directed by a person manually. The moving range will be recorded by the system and stored in computer.
Time Frame
Baseline
Title
Wrist's active range of motion
Description
Wrist's active range of motion is a measurement to identify how far the person's joints range can move in flexion/extension, and radial deviation/ulnar deviation by moving with their own effort. The moving range will be recorded by the system and stored in computer.
Time Frame
Baseline
Title
Wrist's Passive Range of Motion
Description
Wrist's passive range of motion is a measurement to identify how far the person's joints range can move in flexion/extension, and radial deviation/ulnar deviation directed by a person manually. The moving range will be recorded by the system and stored in computer.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Sub-acute and chronic stroke patients (ischemic or hemorrhagic).
Sufficient cognition to follow simple instructions as well as understand the content and purpose of the study.
Exclusion criteria:
Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication.
Any additional medical or psychological condition affecting their ability to comply with the study protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Kai-yu Tong
Phone
+85239438454
Email
kytong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Kai-yu Tong
Organizational Affiliation
Department of Biomedical Engineering, The Chinese University of Hong Kong
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
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Pilot Study of Motor-cable-driven System for Stroke Wrist and Forearm Rehabilitation
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