- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06877819
Additional Effects of Motor Imaginary Technique Along With Task Oriented Trunk Control Training
Additional Effects of Motor Imagery Technique Along With Task Oriented Trunk Control Training on Postural Control And Mobility 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 Province
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Islamabad, Punjab Province, Pakistan, 44080
- National Institute of Rehab Medicine, Nijaat Ambulance & Old Age Home
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with sub-acute stroke (> 3 months stroke till 6 months after stroke)
- Both male and female are included.
- Patient with stage 2 of postural control on Chedoke McMaster Stroke Assessment Score.
- Patient who are able to sit without holding on to objects/people
- Patient who are able to stand for 30seconds
- Patient able to flex non-paretic shoulder upto 90 degree, without holding on to any object
- Patients with no cognitive deficits ( score > 25 on Montreal Cognitive Assessment Tool)
- Patients with moderate spasticity of upper/lower extremity (Modified Ashworth Scale Grade = 1, +1)
Exclusion Criteria
- Patients with visuo-spatial neglect.
- Patients with hearing impairment
- Hip pathologieOlder adults 60 years & aboves or any condition other than stroke interfering with trunk movements will be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motor Imaginary alongwith Task Oriented Training
patient will first imagine task task-based based activities with closed eyes while listening to the audio using headphones, this will be followed by practical implication of same tasks and coventional physiotherapy.
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Motor imaginary technique followed by task oriented trunk control training alongwith conventional physiotherapy.Frequency: 10- 15 reps 4 times/week for 8 consecutive weeks.
Time for each session will be 60 mins.
First of all task based exercises will be assumed by patient.
To make imaginations more strong an audio demonstration of each exercise will be recorded by therapist and will be administered to patients hearing via headphones.
This will make it easy for patients to assume as they are performing theses exercises in their head.
Motor imagination will be followed by practical performance of same tasks.
The experimental group will receive motor imagery technique for 15 minutes followed by task-specific training for 45minutes along with conventional physiotherapy to improve postural control and balance in stroke patients. .
|
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Active Comparator: Task Oriented Training
patient will be asked to perform task based activities followed by conventional physiotherapy
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Control group will receive task oriented trunk control training exercises followed by conventional physiotherapy.
.Frequency: 10- 15 reps 4 times/week for 8 consecutive weeks.
Time for each session will be 60 mins.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Assesment Scale for Stroke
Time Frame: 8 weeks
|
it was developed in 1999 as an adaptation to fugyl-meyer scale. PASS scale is designed for stroke patient to assess and monitor postural control after stroke. Multiple studies support the predictive validity of the PASS. PASS demonstrated excellent predictive validity at 14, 30, 90 and 180 days post stroke (α=0.86-0.90), as measured using Spearman's p correlation coefficient. The PASS scale is composed of 2 sections of posture I.e: maintaining posture and changing a posture. it is a 4-point scale and consist a total of 12 items with total score of 36. |
8 weeks
|
|
Trunk Impairment Scale
Time Frame: 8 weeks
|
TIS was developed by Verheydenet.
al to evaluate trunk control in stroke patients.
TIS assesses static and dynamic sitting balance and trunk coordination in a sitting position.
The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
Test/retest and interobserver reliability for the TIS total score (ICC) - 0.96 and 0.99, respectively.
The 95% limits of agreement for the test/retest and interexaminer measurement error - 2/2.90, 3.68 and 2/1.84, 1.84, respectively.
Cronbach alpha coefficients for internal consistency range from 0.65 to 0.89.
|
8 weeks
|
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Berg Balance Scale
Time Frame: 8 weeks
|
The Berg Balance Scale (BBS) is used to determine balance Impairment in elderly.
population and in patients with strok .
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
The Berg Balance Scale has a high relative reliability with inter-rater reliability estimated at 0.97 (95% CI 0.96 to 0.98) and intra-rater reliability estimated at 0.98 (95% CI 0.97 to 0.99).
|
8 weeks
|
|
Functional Reach Test
Time Frame: 8 weeks
|
In 1990 Pamela Duncan and colleagues developed Functional Reach test.
It is single-task, dynamic test that is used to predict falls in older adults.
This test measures the margin of stability along with the ability to measure balance during a functional task.
Correlation values were 0.86 and 0.87 at two different times, with a correlation coefficient greater than 0.76 is a strong predictor of fall.
|
8 weeks
|
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Time-Up and-Go Test
Time Frame: 8 weeks
|
The Timed Up and Go (TUG) is a commonly used outcome measure that can assess activity limitations in the ICF model by examining the patient's ability to ambulate and perform transfers.
The Timed up and Go test has excellent inter-rater correlation (ICC) = 0.99, and high intra-rater reliability (ICC = 0.99).
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8 weeks
|
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5 Times sit-t-To-Stand Test
Time Frame: 8 weeks
|
5 times sit to stand test (5XSST) measures functional lower limb muscle strength and may be useful in quantifying functional change of transitional movements.
The 5XSST test has excellent intra-rater reliability (intraclass correlation coefficient (ICC) range: 0.914-0.933)
and excellent test-retest reliability (ICC range: 0.988-0.995) in healthy older adults.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arshad Nawaz Malik, PhD Rehab, Riphah International University
- Principal Investigator: Minahil Butt, MS-NMPT*, Riphah International University
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/MS-PT/02027 Minahil Butt
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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