- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06303050
Additional Effects of Mental Imagery Along With Task Oriented Training on Kinesiophobia in Patients With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cerebrovascular accident (CVA),commonly known as stroke , occurs when blood flow to the brain is disrupted , either by a clot or by rupture in a blood vessel .It can lead to severe neurological damaged or even death. A stroke can cause neurological deficits in various domains of brain areas, include motor, sensory/perceptive, visual, language, intelligence and emotion. Motor deficits are one of the most common and disabling consequences of stroke.
Kinesiophobia is a psychological condition characterized by an excessive, irrational fear of movement and physical activity due to the belief that it will increase pain or worsen a pre medical condition. It can be a common obstacle to rehabilitation and recovery for individuals with various musculoskeletal or neurological conditions, including stroke.
MI has been recognized as an effective adjunct therapy to physical rehabilitation for various neurological conditions, including stroke. Task-oriented training is a widely adopted approach in stroke rehabilitation, which emphasizes the practice of functional tasks to promote motor skill learning and improve motor function.
However the potential benefits of combining mental imagery with task-oriented train-ing have not been fully explored. Therefore studying the additional effects of mental imagery along with task-oriented training on Kinesiophobia in patients with stroke is important for developing more effective and comprehensive rehabilitation interven-tions for stroke populations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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KPK
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Peshawar, KPK, Pakistan, 2500
- Khyber Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hemiplegic stroke patients
- Age above 45
- Both genders
- Patients having score >17 on Tempa Scale of Kinesiophobia
- Patients of score >21 on Berg Balance Scale
Exclusion Criteria:
• Communication deficits and unable to follow instructions
- A history of serious or unstable cardiac condition
- Severe musculoskeletal problem and unable to stand or walk
- History of other neurological diseases or unilateral neglect
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 |
|---|---|
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Experimental: Mental Imagery with task Oriented training group
Participants will perform warm-up exercise for 5 minutes to prepare the body for functional task and to improve overall performance.
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Study will be conducted after the approval of Ethical review board.
After the initial evaluation will be done on participants underlying eligibility criteria.
The experimental group will receive 20 minutes of MI training followed by 25 minutes of TOT for a total of 45 minutes, 5 days per week for 6 weeks.
During each 45 minutes of session, the participants will perform warm-up exercise for 5 minutes to prepare the body for functional task and to improve overall performance.
Regular breaks will give to the participants to avoid overexertion and fatigue during 45 minutes of continues practice.
The 2 minutes rest period will provide to the partici-pants during each practice session
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Active Comparator: Task Oriented training group
Task oriented training In standing, forward stepping and sideward stepping, reaching in standing, Transition from sit to stand, Walk then back to sit, Walk with even steps, Walk with carrying objects.
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Study will be conducted after the approval of Ethical review board.
After the initial evaluation will be done on participants underlying eligibility criteria.
The control group will receive the Task oriented training for 25-30 minutes, 05 days a week for 06 weeks consisting of Warm up Period, Task oriented training In standing, forward stepping and sideward stepping, reaching in standing, Transition from sit to stand, Walk then back to sit, Walk with even steps, Walk with carrying objects.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Berg And Balance scale
Time Frame: 6 weeks
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changes from the baseline, Berg balance scale (BBS) is used for assessment of balance and fall risk, Higher scores on the BBS indicate greater independence and better ability to balance.
In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL __/56
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6 weeks
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Tempa scale for kinesiophobia
Time Frame: 6 weeks
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It consists of 17 items asking patients to rate their responses to statements related to fear of movement and re injury.
It has been widely used among patients with various types of pain and has been translated into several languages.
The TSK-17 is a useful tool for assessing kinesiophobia and can aid clinicians in developing appropriate treatment plans for patients who may have fear of movement due to pain or injury (20).
The TSK exhibit high level of in- ternal consistency across all items and is positively associated with related measures of fear avoidance, pain catastrophizing, pain related disability.
In the Finnish version of TSK the test-retest reliability
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6 weeks
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Ten-meter walk test
Time Frame: 6 weeks
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The 10- meter walk test is a commonly used tool to measure gait and walking speed in individuals with mobility impairments, including post-stroke individuals.
During the test subjects are instructed to walk along a 10-meter walkway at their preferred walking speed, with or without a customary walking device, without any break to the end point.
The time taken to recover the middle 4 meters of the walkway is recorded to obtain a rhythmic phase of walking speed.
This ensures that the acceleration and deceleration phases of walking are excluded from the measurement of walking speed.
Then the time required over three trials is converted to walking speed by dividing the distance (6 meters) by the time taken in seconds to complete the walk.
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6 weeks
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Dynamic gate index
Time Frame: 6 weeks
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The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent. Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24. |
6 weeks
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Time Up and Go Test
Time Frame: 6 weeks
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Timed up and go test is used for the assessment of falls risk among the elderly population.
The Timed "Up and Go" (TUG) Test measures, in seconds, the time is taken by an individual to stand up from a standard armchair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.
Normal healthy elderly usually complete the task in 10 seconds or less.
Very frail or weak elderly with poor mobility may take 2 minutes or more.
Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate a high risk of falls.
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nadia Azhar, 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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Urooj Amir
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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