Rapid Movement Therapy for Stroke Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Procedure: Balance training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinect based Rapid Movement Therapy; 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.	Procedure: Balance training; Improvement of balance ability in stroke patients
Placebo Comparator: Conventional balance training; Conventional balance training involves some slow and low-impact muscle strengthening and mobilizing exercises.	Procedure: Balance training; Improvement of balance ability in stroke patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale (BBS)	A 14-item objective measure designed to assess static balance and fall risk in adult populations	3-month follow-up
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Electromyography (EMG)	It is used to detect the muscle activity	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.	3-month follow-up

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Raymond Kai-yu Tong, PhD, Department of Biomedical Engineering, CUHK

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): June 22, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 12131911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No