NCT03698357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

April 10, 2019

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

October 4, 2018

Last Update Submit

April 8, 2019

Conditions

Stroke

Keywords

interactive video balance-based exerciseconventional physiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change of Time Up Go test (TUG)

    Measurement before and after intervention ( week 0 and at the end of week 4) in both groups

  • Change of Modified Falls Efficacy Scale (MFES)

    Measurement before and after intervention ( week 0 and at the end of week 4) in both groups

  • Change of Motricity Index (MI)

    Measurement before and after intervention ( week 0 and at the end of week 4) in both groups

  • Change of Functional Ambulation Category (FAC)

    Measurement before and after intervention ( week 0 and at the end of week 4) in both groups

Study Arms (2)

Interactive video balance-based exercise

EXPERIMENTAL

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

Conventional physiotherapy

ACTIVE COMPARATOR

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

Interventions

interactive video balance-based exerciseBEHAVIORAL

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.

Interactive video balance-based exercise
Conventional physiotherapyBEHAVIORAL

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.

Conventional physiotherapy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients present with unilateral hemiplegia caused by a first-ever stroke
  • cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score\>=23)
  • medical and psychological condition stable

You may not qualify if:

  • patients having severe spasticity (Modified Ashworth scale \> 3)
  • severe hearing or eye problem
  • intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical university Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 33902646DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Chien-Hung Lai, MD PhD

    Taipei Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 9, 2018

Study Start

September 4, 2017

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

April 10, 2019

Record last verified: 2018-10

Locations

TW(1)