Video Balance-based Exercise in Persons With Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698357
• Other study ID #: N201708024
• Status: Completed
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: October 2018
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical university Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
Secondary	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.	Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
Secondary	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.	Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
Secondary	Change of Motricity Index (MI)	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
Secondary	Change of Functional Ambulation Category (FAC)	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