Clinical trial NCT03698357: Video Balance-based Exercise in Persons With Stroke
Official title: Effect of Interactive Video Balance-based Exercise in Persons With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: interactive video balance-based exercise
conventional physiotherapy
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change of Berg Balance Scale (BBS)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
Secondary outcomes:
measure: Change of Time Up Go test (TUG)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
measure: Change of Modified Falls Efficacy Scale (MFES)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
measure: Change of Motricity Index (MI)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
measure: Change of Functional Ambulation Category (FAC)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 4) in both groups
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical university Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Chien-Hung Lai, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen SC, Lin CH, Su SW, Chang YT, Lai CH. Feasibility and effect of interactive telerehabilitation on balance in individuals with chronic stroke: a pilot study. J Neuroeng Rehabil. 2021 Apr 26;18(1):71. doi: 10.1186/s12984-021-00866-8.