Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 441 for:    Taipei Medical University Hospital

Video Balance-based Exercise in Persons With Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03698357
Recruitment Status : Active, not recruiting
First Posted : October 8, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Lai chien hung, Taipei Medical University Hospital

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 Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 4, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698357


Locations
Layout table for location information
Taiwan
Taipei Medical university Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chien-Hung Lai, MD PhD Taipei Medical University Hospital

Layout table for additonal information
Responsible Party: Lai chien hung, Professor, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT03698357     History of Changes
Other Study ID Numbers: N201708024
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lai chien hung, Taipei Medical University Hospital:
interactive video balance-based exercise
conventional physiotherapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases