Video Balance-based Exercise in Persons With Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: interactive video balance-based exercise; Behavioral: Conventional physiotherapy

• Registration Number: NCT03698357
• Lead Sponsor: Taipei Medical University Hospital

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

Study Timeline

• Study Start: 2017-09-04
• Status Verified: 2018-10
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-09
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interactive video balance-based exercise	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.
Conventional physiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Change of Berg Balance Scale (BBS)	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.

Secondary Outcome Measures

Name	Time	Method
Change of Modified Falls Efficacy Scale (MFES)	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.
Change of Time Up Go test (TUG)	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.
Change of Motricity Index (MI)	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.
Change of Functional Ambulation Category (FAC)	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.

Trial Locations

Locations (1)

Taipei Medical university Hospital; 🇨🇳 Taipei, Taiwan