Stroke Clinical Trial
Official title:
A Randomized Controlled Trial of Rapid Movement Therapy With Real-time Feedback to Improve Balance Recovery for Fall Prevention After Stroke
NCT number | NCT03183635 |
Other study ID # | 12131911 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 19, 2017 |
Est. completion date | October 30, 2018 |
Verified date | December 2020 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 30, 2018 |
Est. primary completion date | June 22, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: 1. have single stroke with onset >1 year, 2. have unilateral paresis, 3. are 50 years of age or older, 4. able to stand without aid for at least 15min, 5. have moderate level of motor impairment in the affective upper limb, i.e. 15= Fugl-Meyer Assessment for upper-extremity(FMA-UE) = 45, 6. have some level of deficit in balance control, i.e. Berg Balance Scale(BBS)< 52/56, 7. have a minimum Snellen visual acuity of 20/40 with/without spectacles, 8. have a minimum Mini-Mental-Status-Examination score of 22/30, and 9. have to be able to follow the training procedures. Exclusion Criteria: 1. enrolled in other rehabilitation program in the study duration, 2. have other neurological conditions in addition to stroke (e.g. Parkinson's disease), 3. have unstable cardiovascular disease (e.g. history of heart disease, or poorly controlled hypertension, i.e. blood pressure >160mmHg/100mmHg), or 4. have other serious diseases or conditions (e.g. osteoporosis, recent joint replacement surgery, amputation) that preclude them from participating in the study. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Biomedical Engineering, The Chinese University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Berg Balance Scale (BBS) | A 14-item objective measure designed to assess static balance and fall risk in adult populations | 3-month follow-up | |
Primary | Timed Up and Go (TUG) | It is used to assess mobility, balance, walking ability, and fall risk in older adults | 3-month follow-up | |
Secondary | Fugl-Meyer Assessment (FMA) of Motor Recovery after Stroke | It is used to evaluate and measure recovery in post-stroke hemiplegic patients | 3-month follow-up | |
Secondary | Activities-specific Balance Confidence (ABC) Scale | Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness | 3-month follow-up | |
Secondary | 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 | 3-month follow-up | |
Secondary | Electromyography (EMG) | It is used to detect the muscle activity | 3-month follow-up | |
Secondary | "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. | 3-month follow-up |
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