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Completed

NCT Number: NCT03698357

Video Balance-based Exercise in Persons With Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical university Hospital

Taipei, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

interactive video balance-based exercise

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change of Berg Balance Scale (BBS)

    Time frame: 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 outcomes

  1. Change of Time Up Go test (TUG)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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