Skip to main content
OpenTrials
Completed

NCT Number: NCT03183635

Rapid Movement Therapy for Stroke Rehabilitation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balance Training

Procedure

Improvement of balance ability in stroke patients

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Fugl-Meyer Assessment (FMA) of Motor Recovery after Stroke

    Time frame: 3-month follow-up

    It is used to evaluate and measure recovery in post-stroke hemiplegic patients

  2. Activities-specific Balance Confidence (ABC) Scale

    Time frame: 3-month follow-up

    Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness

  3. Barthel Index of Activities of Daily Living

    Time frame: 3-month follow-up

    It is used to assess the ability of an individual with a neuromuscular or musculoskeletal disorder to care for him/herself

  4. Electromyography (EMG)

    Time frame: 3-month follow-up

    It is used to detect the muscle activity

  5. "lean-and-release" postural system

    Time frame: 3-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

A Randomized Controlled Trial of Rapid Movement Therapy With Real-time Feedback to Improve Balance Recovery for Fall Prevention After Stroke

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2017
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.