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Video Balance-based Exercise in Persons With Stroke

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

interactive video balance-based exercise

Conventional physiotherapy

About this trial

This is an interventional treatment trial for Stroke focused on measuring interactive video balance-based exercise, conventional physiotherapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Taipei Medical university Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interactive video balance-based exercise

Conventional physiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Change of Berg Balance Scale (BBS)

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.

Secondary Outcome Measures

Change of Time Up Go test (TUG)

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.

Change of Modified Falls Efficacy Scale (MFES)

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.

Change of Motricity Index (MI)

The MI reflects general muscle strength in persons with stroke.

Change of Functional Ambulation Category (FAC)

The FAC is based on the required level of assistance during walking in individuals with stroke.

Full Information

NCT ID

NCT03698357

First Posted

October 4, 2018

Last Updated

April 8, 2019

Sponsor

Taipei Medical University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03698357

Brief Title

Video Balance-based Exercise in Persons With Stroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

September 4, 2017 (Actual)

Primary Completion Date

March 30, 2019 (Actual)

Study Completion Date

March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taipei Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

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

Stroke

Keywords

interactive video balance-based exercise, conventional physiotherapy

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

Interactive video balance-based exercise

Arm Type

Experimental

Arm Description

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.

Arm Title

Conventional physiotherapy

Arm Type

Active Comparator

Arm Description

Another 15 participants allocated to the group B will receive 30 minutes a day and 3 days a week conventional rehabilitation for four weeks.

Intervention Type

Behavioral

Intervention Name(s)

interactive video balance-based exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Conventional physiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of Berg Balance Scale (BBS)

Description

Time Frame