StrokeNCT03286309
Soft Robotic Hand System for Stroke Rehabilitation
A study testing soft robot hand system in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The soft robotic system could provide objective and quantifiable measures of subject performance. By combining voluntary motor intention and the robotic hand technology, the system will facilitate the recovery process of stroke patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- soft robot hand system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Apr 2018to 1 Jul 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- at chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic);
- sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
- able to sit up for 45 minutes (with or without assistance).
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;
- history of other neurological disease, psychiatric disorder, including alcoholism and substance abuse.
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
Shatin
Raymond Tong, PhD, +852 3943 8454
About this study
The soft robotic system could provide objective and quantifiable measures of subject performance. By combining voluntary motor intention and the robotic hand technology, the system will facilitate the recovery process of stroke patients.
- Conditions
- Stroke
- Being tested
- soft robot hand system
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft robot hand systemDevice
subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.
| Study group | Role | What they receive |
|---|---|---|
| EMG-driven soft robot hand | Experimental | subjects will receive EMG-driven soft robot hand system. Receives: Device: soft robot hand system |
| sham group | Placebo comparator | subjects will receive passive pre-programmed soft robot hand system. Receives: Device: soft robot hand system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb Fugl Meyer Assessment
Measured: 3-month follow up
Secondary outcomes (4)
Action Research Arm Test
Measured: 3-month follow up
Modified Ashworth Scale
Scale from 0 to 4, whereas 0 is no increase in tone and 4 is limb rigid in flexion or extension
Measured: 3-month follow up
Box and Block Test
Measured: 3-month follow up
Max Voluntary Grip Force
Measured: 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start12 Apr 2018
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 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, PhD, Principal investigator, Department of Biomedical Engineering, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286309
- Sponsor's protocol ID
- 2017.396-T
- Status last verified
- May 2022
- First submitted
- 15 Sep 2017
- Last updated
- 23 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi XQ, Ti CE, Lu HY, Hu CP, Xie DS, Yuan K, Heung HL, Leung TW, Li Z, Tong RK. Task-Oriented Training by a Personalized Electromyography-Driven Soft Robotic Hand in Chronic Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2024 Aug;38(8):595-606. doi: 10.1177/15459683241257519. Epub 2024 May 29.
PubMed 38812378
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Robotic Hand System for Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT03286309
- Acronym / sponsor ID
- 2017.396-T
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 18 Sep 2017 (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 soft robotic system could provide objective and quantifiable measures of subject performance. By combining voluntary motor intention and the robotic hand technology, the system will facilitate the recovery process of stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMG-driven soft robot hand | Experimental | Device: soft robot hand systemsubjects will receive EMG-driven soft robot hand system. |
| sham group | Placebo comparator | Device: soft robot hand systemsubjects will receive passive pre-programmed soft robot hand system. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- at chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic);
- sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
- able to sit up for 45 minutes (with or without assistance).
Key exclusion criteria (3 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;
- history of other neurological disease, psychiatric disorder, including alcoholism and substance abuse.
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 |
|---|---|---|
| soft robot hand systemsubjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise. | Device | EMG-driven soft robot hand, sham group |
Primary outcome
Upper limb Fugl Meyer Assessment
Time frame: 3-month follow up
4 secondary outcomes
Action Research Arm Test
Time frame: 3-month follow up
Modified Ashworth Scale
Time frame: 3-month follow up
Box and Block Test
Time frame: 3-month follow up
Max Voluntary Grip Force
Time frame: 3-month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 38812378Shi XQ, Ti CE, Lu HY, Hu CP, Xie DS, Yuan K, Heung HL, Leung TW, Li Z, Tong RK. Task-Oriented Training by a Personalized Electromyography-Driven Soft Robotic Hand in Chronic Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2024 Aug;38(8):595-606. doi: 10.1177/15459683241257519. Epub 2024 May 29.
- Individual participant dataSharing planned: No
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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, PhD principal investigator
Department of Biomedical Engineering, CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft robot hand 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 3 inclusion and 3 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 23 May 2022. 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. Some participants in this study may receive a placebo. 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, PhD (+852 3943 8454, kytong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb Fugl Meyer Assessment (time frame: 3-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03286309, which also lists 1 linked publication.
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 23 May 2022.