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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2020
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Balance training
Improvement of balance ability in stroke patients

Locations

Country Name City State
Hong Kong Department of Biomedical Engineering, The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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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