Video Balance-based Exercise in Persons With Stroke

• Sponsor: Taipei Medical University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03698357
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.8
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: interactive video balance-based exercise; Behavioral: Conventional physiotherapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Interactive Video Balance-based Exercise in Persons With Stroke
• Actual Study Start Date: Sep 4, 2017
• Actual Primary Completion Date: Mar 30, 2019
• Actual Study Completion Date: Mar 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Medical university Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Taipei Medical University Hospital

Investigators

• Principal Investigator: Chien-Hung Lai, MD PhD, Taipei Medical University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lai chien hung, Professor, Taipei Medical University Hospital
• ClinicalTrials.gov Identifier: NCT03698357
• Other Study ID Numbers: N201708024
• First Posted: Oct 9, 2018
• Last Update Posted: Apr 10, 2019
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lai chien hung, Professor, Taipei Medical University Hospital: interactive video balance-based exercise; conventional physiotherapy
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Apr 10, 2019