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Rapid Movement Therapy for Stroke Rehabilitation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Balance training
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Biomedical Engineering, The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Kinect based Rapid Movement Therapy

Conventional balance training

Arm Description

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.

Conventional balance training involves some slow and low-impact muscle strengthening and mobilizing exercises.

Outcomes

Primary Outcome Measures

Berg Balance Scale (BBS)
A 14-item objective measure designed to assess static balance and fall risk in adult populations
Timed Up and Go (TUG)
It is used to assess mobility, balance, walking ability, and fall risk in older adults

Secondary Outcome Measures

Fugl-Meyer Assessment (FMA) of Motor Recovery after Stroke
It is used to evaluate and measure recovery in post-stroke hemiplegic patients
Activities-specific Balance Confidence (ABC) Scale
Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness
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
Electromyography (EMG)
It is used to detect the muscle activity
"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.

Full Information

First Posted
September 14, 2016
Last Updated
December 10, 2020
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03183635
Brief Title
Rapid Movement Therapy for Stroke Rehabilitation
Official Title
A Randomized Controlled Trial of Rapid Movement Therapy With Real-time Feedback to Improve Balance Recovery for Fall Prevention After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinect based Rapid Movement Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional balance training
Arm Type
Placebo Comparator
Arm Description
Conventional balance training involves some slow and low-impact muscle strengthening and mobilizing exercises.
Intervention Type
Procedure
Intervention Name(s)
Balance training
Intervention Description
Improvement of balance ability in stroke patients
Primary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
Description
A 14-item objective measure designed to assess static balance and fall risk in adult populations
Time Frame
3-month follow-up
Title
Timed Up and Go (TUG)
Description
It is used to assess mobility, balance, walking ability, and fall risk in older adults
Time Frame
3-month follow-up
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA) of Motor Recovery after Stroke
Description
It is used to evaluate and measure recovery in post-stroke hemiplegic patients
Time Frame
3-month follow-up
Title
Activities-specific Balance Confidence (ABC) Scale
Description
Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness
Time Frame
3-month follow-up
Title
Barthel Index of Activities of Daily Living
Description
It is used to assess the ability of an individual with a neuromuscular or musculoskeletal disorder to care for him/herself
Time Frame
3-month follow-up
Title
Electromyography (EMG)
Description
It is used to detect the muscle activity
Time Frame
3-month follow-up
Title
"lean-and-release" postural system
Description
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.
Time Frame
3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Kai-yu Tong, PhD
Organizational Affiliation
Department of Biomedical Engineering, CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biomedical Engineering, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34635141
Citation
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.
Results Reference
derived

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Rapid Movement Therapy for Stroke Rehabilitation

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