StrokeNCT03183635
Rapid Movement Therapy for Stroke Rehabilitation
A study testing Balance training in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Stroke survivors have higher risks of falling compared to other healthy non-stroke adults. Stroke patients' balance can be trained by Kinect-based training that enable user friendly and interactive training. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Balance training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Jun 2017to 30 Oct 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have single stroke with onset >1 year,
- have unilateral paresis,
- are 50 years of age or older,
- able to stand without aid for at least 15min,
- have moderate level of motor impairment in the affective upper limb, i.e. 15≤ Fugl-Meyer Assessment for upper-extremity(FMA-UE) ≤ 45,
- have some level of deficit in balance control, i.e. Berg Balance Scale(BBS)< 52/56,
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- have a minimum Snellen visual acuity of 20/40 with/without spectacles,
- have a minimum Mini-Mental-Status-Examination score of 22/30, and
- have to be able to follow the training procedures.
Who cannot join
- enrolled in other rehabilitation program in the study duration,
- have other neurological conditions in addition to stroke (e.g. Parkinson's disease),
- have unstable cardiovascular disease (e.g. history of heart disease, or poorly controlled hypertension, i.e. blood pressure >160mmHg/100mmHg), or
- have other serious diseases or conditions (e.g. osteoporosis, recent joint replacement surgery, amputation) that preclude them from participating in the study.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: A Randomized Controlled Trial of Rapid Movement Therapy With Real-time Feedback to Improve Balance Recovery for Fall Prevention After Stroke
Stroke survivors have higher risks of falling compared to other healthy non-stroke adults. Stroke patients' balance can be trained by Kinect-based training that enable user friendly and interactive training.
- Conditions
- Stroke
- Being tested
- Balance training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingProcedure or surgery
Improvement of balance ability in stroke patients
| Study group | Role | What they receive |
|---|---|---|
| Kinect based Rapid Movement Therapy | Experimental | Kinect based Rapid Movement Therapy (RMT) training requires participants to move their limbs very rapidly to reach-to-grasp or step towards a virtual target appear suddenly on a screen, which is designed to their range of motion as well as response speed. Receives: Procedure: Balance training |
| Conventional balance training | Placebo comparator | Conventional balance training involves some slow and low-impact muscle strengthening and mobilizing exercises. Receives: Procedure: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
A 14-item objective measure designed to assess static balance and fall risk in adult populations
Measured: 3-month follow-up
Timed Up and Go (TUG)
It is used to assess mobility, balance, walking ability, and fall risk in older adults
Measured: 3-month follow-up
Secondary outcomes (5)
Fugl-Meyer Assessment (FMA) of Motor Recovery after Stroke
It is used to evaluate and measure recovery in post-stroke hemiplegic patients
Measured: 3-month follow-up
Activities-specific Balance Confidence (ABC) Scale
Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness
Measured: 3-month follow-up
Barthel Index of Activities of Daily Living
It is used to assess the ability of an individual with a neuromuscular or musculoskeletal disorder to care for him/herself
Measured: 3-month follow-up
Electromyography (EMG)
It is used to detect the muscle activity
Measured: 3-month follow-up
"lean-and-release" postural system
It is used to evaluate balance-recovery in chronic stroke patients. Participants will wear a safety harness designed to prevent impact between body and floor, and they will be asked to stand on two force plates in standardized stance and lean forward with around 10% body weight supported by a cable attached to a release mechanism. Compensatory balance-recovery reactions will be evoked by the sudden release of the support cable, inducing a forward fall. Participants will be evaluated under three different conditions: no handrail, handrail on the unaffected side, and handrail on the affected side.
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 posted12 Jun 2017
- Study start19 Jun 2017
- Primary completion22 Jun 2018
- Study completion30 Oct 2018
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
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
- NCT03183635
- Sponsor's protocol ID
- 12131911
- Status last verified
- Dec 2020
- First submitted
- 14 Sep 2016
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Junata M, Cheng KC, Man HS, Lai CW, Soo YO, Tong RK. Kinect-based rapid movement training to improve balance recovery for stroke fall prevention: a randomized controlled trial. J Neuroeng Rehabil. 2021 Oct 11;18(1):150. doi: 10.1186/s12984-021-00922-3.
PubMed 34635141
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Rapid Movement Therapy With Real-time Feedback to Improve Balance Recovery for Fall Prevention After Stroke
- ClinicalTrials.gov ID
- NCT03183635
- Acronym / sponsor ID
- 12131911
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 12 Jun 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.
Stroke survivors have higher risks of falling compared to other healthy non-stroke adults. Stroke patients' balance can be trained by Kinect-based training that enable user friendly and interactive training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinect based Rapid Movement Therapy | Experimental | Procedure: Balance trainingKinect based Rapid Movement Therapy (RMT) training requires participants to move their limbs very rapidly to reach-to-grasp or step towards a virtual target appear suddenly on a screen, which is designed to their range of motion as well as response speed. |
| Conventional balance training | Placebo comparator | Procedure: Balance trainingConventional balance training involves some slow and low-impact muscle strengthening and mobilizing exercises. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- have single stroke with onset >1 year,
- have unilateral paresis,
- are 50 years of age or older,
- able to stand without aid for at least 15min,
- have moderate level of motor impairment in the affective upper limb, i.e. 15≤ Fugl-Meyer Assessment for upper-extremity(FMA-UE) ≤ 45,
Key exclusion criteria (4 listed)
- enrolled in other rehabilitation program in the study duration,
- have other neurological conditions in addition to stroke (e.g. Parkinson's disease),
- have unstable cardiovascular disease (e.g. history of heart disease, or poorly controlled hypertension, i.e. blood pressure >160mmHg/100mmHg), or
- have other serious diseases or conditions (e.g. osteoporosis, recent joint replacement surgery, amputation) that preclude them from participating in the study.
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 |
|---|---|---|
| Balance trainingImprovement of balance ability in stroke patients | Procedure or surgery | Conventional balance training, Kinect based Rapid Movement Therapy |
Primary outcome
Berg Balance Scale (BBS)
Time frame: 3-month follow-up
A 14-item objective measure designed to assess static balance and fall risk in adult populations
Timed Up and Go (TUG)
Time frame: 3-month follow-up
It is used to assess mobility, balance, walking ability, and fall risk in older adults
5 secondary outcomes
Fugl-Meyer Assessment (FMA) of Motor Recovery after Stroke
Time frame: 3-month follow-up
Activities-specific Balance Confidence (ABC) Scale
Time frame: 3-month follow-up
Barthel Index of Activities of Daily Living
Time frame: 3-month follow-up
Electromyography (EMG)
Time frame: 3-month follow-up
"lean-and-release" postural system
Time frame: 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 34635141Junata M, Cheng KC, Man HS, Lai CW, Soo YO, Tong RK. Kinect-based rapid movement training to improve balance recovery for stroke fall prevention: a randomized controlled trial. J Neuroeng Rehabil. 2021 Oct 11;18(1):150. doi: 10.1186/s12984-021-00922-3.
- 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 Balance training 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 9 inclusion and 4 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: finished, as of the sponsor's last update on 11 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) (time frame: 3-month follow-up). 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?
On the ClinicalTrials.gov record for NCT03183635, 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 11 Dec 2020.