StrokeNCT06062121
Pilot Study of Motor-cable-driven System for Stroke Wrist and Forearm Rehabilitation
A study testing Motor-cable-driven Rehabilitation Robotic System in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Motor-cable-driven Rehabilitation Robotic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong
Raymond Tong, PhD, +852 3943 8454
About this study
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.
- Conditions
- Stroke
- Being tested
- Motor-cable-driven Rehabilitation Robotic System
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor-cable-driven Rehabilitation Robotic SystemDevice
Subjects will wear the motor-cable-driven system and receive 30 minutes (including preparation time) wrist and forearm robot-assisting exercise
| Study group | Role | What they receive |
|---|---|---|
| motor-cable-driven system | Experimental | Receive motor-cable-driven system Receives: Device: Motor-cable-driven Rehabilitation Robotic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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.
Measured: Baseline
Secondary outcomes (7)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond KY Tong, Chinese University of Hong Kong
- Investigators
- Raymond Kai-yu Tong, Principal investigator, Department of Biomedical Engineering, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062121
- Sponsor's protocol ID
- 2023.166
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Motor-cable-driven System for Stroke Wrist and Forearm Rehabilitation
- ClinicalTrials.gov ID
- NCT06062121
- Acronym / sponsor ID
- 2023.166
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| motor-cable-driven system | Experimental | Device: Motor-cable-driven Rehabilitation Robotic SystemReceive motor-cable-driven system |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor-cable-driven Rehabilitation Robotic SystemSubjects will wear the motor-cable-driven system and receive 30 minutes (including preparation time) wrist and forearm robot-assisting exercise | Device | motor-cable-driven system |
Primary outcome
Forearm's Assisted Range of Motion
Time frame: Baseline
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
Time frame: Baseline
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.
7 secondary outcomes
Upper limb Fugl-Meyer Assessment (FMA)
Time frame: Baseline
Motor Assessment Scale (MAS)
Time frame: Baseline
Modified Ashworth Scale
Time frame: Baseline
Forearm's Active Range of Movement
Time frame: Baseline
Forearm's Passive Range of Motion
Time frame: Baseline
Wrist's active range of motion
Time frame: Baseline
Wrist's Passive Range of Motion
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Kai-yu Tong principal investigator
Department of Biomedical Engineering, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor-cable-driven Rehabilitation Robotic System in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raymond Kai-yu Tong (+85239438454, kytong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm's Assisted Range of Motion (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.