Video Balance-based Exercise in Persons With Stroke

April 8, 2019 updated by: Lai chien hung, Taipei Medical University Hospital

Effect of Interactive Video Balance-based Exercise in Persons With Stroke

This study is to compare the effects of Interactive video balance-based exercise (IVBE) intervention and conventional rehabilitation on the balance and functional performance in stroke survivors. Fifteen participants will receive Interactive video balance-based exercise, while the other half will receive conventional rehabilitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty individuals with stroke are recruited and allocated to 2 groups in this study. Fifteen participants in group A will undergo 30 minutes a day and 3 days a week interactive video balance-based exercise intervention for four weeks. Another 15 participants allocated to the group B will receive 30 minutes a day and 3 days a week conventional rehabilitation for four weeks. Time up go test (TUG), Berg Balance Scale (BBS), Modified Falls Efficacy Scale (MFES), Motricity Index (MI), Functional Ambulation Category (FAC) were assessed before and after intervention in both groups

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients present with unilateral hemiplegia caused by a first-ever stroke
  2. cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score>=23)
  3. medical and psychological condition stable

Exclusion Criteria:

  1. patients having severe spasticity (Modified Ashworth scale > 3)
  2. severe hearing or eye problem
  3. intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interactive video balance-based exercise
Fifteen participants in group A will undergo 30 minutes a day and 3 days a week interactive video balance-based exercise intervention for four weeks.
Behavioral: interactive video balance-based exercise
Interactive video balance-based exercise :10 minutes of warm up exercise, 30 minutes of Interactive video balance-based exercise and 5 minutes of cool down exercise.
Active Comparator: Conventional physiotherapy
Another 15 participants allocated to the group B will receive 30 minutes a day and 3 days a week conventional rehabilitation for four weeks.
Behavioral: Conventional physiotherapy
conventional physiotherapy: 10 minutes of warm up exercise, 30 minutes conventional physiotherapy and 5 minutes of cool down exercise. Conventional physiotherapy contains rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Berg Balance Scale (BBS)
Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
Participants perform a series of 14 functional balance tasks, such as maintaining a quiet stance, sitting-to-stand, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance.
Measurement before and after intervention ( week 0 and at the end of week 4) in both groups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Time Up Go test (TUG)
Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
The TUG test is a quick, reliable, valid, and accurate method commonly used to test dynamic stability and functional mobility. In the test, participants stand up from a 46-cm-high armchair with back support, walk straight for 3 m, turn around, walk back to the chair, and sit down as quickly and safely as possible.
Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
Change of Modified Falls Efficacy Scale (MFES)
Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
The MFES is a 14-item rating scale questionnaire that contains the original 10-activity Falls Efficacy Scale and 4 additional activities. It is used to assess confidence of not falling while performing daily activities.
Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
Change of Motricity Index (MI)
Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
The MI reflects general muscle strength in persons with stroke.
Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
Change of Functional Ambulation Category (FAC)
Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
The FAC is based on the required level of assistance during walking in individuals with stroke.
Measurement before and after intervention ( week 0 and at the end of week 4) in both groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2017

Primary Completion (Actual)

March 30, 2019

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201708024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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