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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03698357
Other study ID # N201708024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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