- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04086004
Dual Task Balance Training With Additional Motor Imagery Practice in Stroke
Additional Effects of Motor Imagery Practice With Dual Task Training in Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Islamabad, Punjab, Pakistan, 46000
- Railway General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Modified Rankin scale disability level 2-3
- Sub acute and chronic stroke patients.
- Ability to walk independently over ground for at least 10 m with or without use of an assistive device
- absence of any cognitive impairment
- No significant body or visual spatial hemi-neglect,
- Good ability for imagery functioning (a score of 32 or higher on the revision of Movement Imagery Questionnaire)
Exclusion Criteria:
-The patient will be excluded if he/she reported serious visual or somatosensory, orthopedic impairments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I Experimental Motor Imagery
Motor imagery practice
|
The experimental group will receive dual task balance training for 30 minutes/day with additional mental imagery for 10 minutes/day, three days/week, for a period of eight weeks
Other Names:
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Experimental: Group II Dual Task Training
Dual-task balance training
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group will receive dual task balance training for 40 minutes for three days/ week for eight weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg balance scale
Time Frame: Change from Baseline balance to 8 Weeks
|
The Berg balance scale (BBS) is used to assess the participant's ability to retain stability.
The BBS is a widely used test for the assessment of elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring.
This test included both static and dynamic type task.
The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points.
The scale has been shown to be reliable and valid in stroke patients.
A cut-off score of 45 points is used for fall prediction.
The BBS involves 14 tasks; a total score of 56.
Equipment required for this test were a stop watch or watch with a second's hand and a ruler or other indicator of 2, 5, and 10 inches.
Excellent reliability (ICC range, 0.98-0.99)
has been found in individuals with stroke survivors for BBS
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Change from Baseline balance to 8 Weeks
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Timed Up and Go test
Time Frame: Change from Baseline balance and mobility to 8 Weeks
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The Timed Up and Go (TUG) test was designed for the evaluation of balance and Measures mobility in people who are able to walk on their own (assistive device permitted) to find out the risk of fall .
The subjects will be required to stand up from a chair, walk 3 m, turn around, return to the chair, and sit down.
The time taken to complete this task will be measured.
The test will be informed three times.
The time required to complete this task will be measured from a stopwatch.
The average values from 3 trials, with 1-min rest between each trial, were used for data analysis.
This test has excellent reliability (ICC > 0.95) with stroke survivors
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Change from Baseline balance and mobility to 8 Weeks
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Functional reach Test:
Time Frame: Change from Baseline balance to 8 Weeks
|
The patient is instructed to stand alongside a wall, however not contacting, a wall and position the arm that is nearer to the wall at 90 degrees of shoulder flexion with a closed fist.
The assessor records the beginning position at the third metacarpal head on the measuring stick.
Teach the patient to "Reach the extent that you can forward without taking a step."
The area of the third metacarpal is recorded before and after a maximal forward reach.
The mean score of three successful trials was calculated.
Test-retest reliability of FR is high (interclass correlation coefficient (ICC) = 0.92) as interrater reliability is (ICC = 0.98)
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Change from Baseline balance to 8 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl Meyer Scale (FMS)
Time Frame: Change from Baseline to 8 Weeks
|
Changes from the Baseline this scale was measured Fugl Meyer Assessment is the utmost extensively used and approved clinical scale for assessment of sensorimotor loss in post stroke patients.This scale is comprised of five domains and there are 155 items in total:
MAS detecting the changes in muscle tone in patients with stroke.. It's a 6 point scale. 0=no muscle tone, 4= affected parts rigid flexion or extension.Its reliability is 0.567. |
Change from Baseline to 8 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Misbah Ghous, MSNMPT, RIPHAH INTERNATIONAL UNIVERSITY ISLAMABAD
Publications and helpful links
General Publications
- Walker C, Brouwer BJ, Culham EG. Use of visual feedback in retraining balance following acute stroke. Phys Ther. 2000 Sep;80(9):886-95.
- Khealani BA, Hameed B, Mapari UU. Stroke in Pakistan. J Pak Med Assoc. 2008 Jul;58(7):400-3.
- Kim SS, Lee HJ, You YY. Effects of ankle strengthening exercises combined with motor imagery training on the timed up and go test score and weight bearing ratio in stroke patients. J Phys Ther Sci. 2015 Jul;27(7):2303-5. doi: 10.1589/jpts.27.2303. Epub 2015 Jul 22.
- Kenyon LK, Blackinton MT. Applying motor-control theory to physical therapy practice: a case report. Physiother Can. 2011 Summer;63(3):345-54. doi: 10.3138/ptc.2010-06. Epub 2011 Aug 10.
- Melzer I, Goldring M, Melzer Y, Green E, Tzedek I. Voluntary stepping behavior under single- and dual-task conditions in chronic stroke survivors: A comparison between the involved and uninvolved legs. J Electromyogr Kinesiol. 2010 Dec;20(6):1082-7. doi: 10.1016/j.jelekin.2010.07.001. Epub 2010 Aug 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Maria Zafar REC/00554
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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