- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484438
Effects of Task Oriented Gait Training With Core Stablization Excercises on 3 Parameters.
Effects of Task-Oriented Gait Training With Core Stabilization Exercises on Mobility, Gait, and Balance in Patients With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is defined as a medical emergency that occurs when blood flow to a part of the brain is interrupted or reduced, preventing brain tissue from receiving essential oxygen and nutrients. This interruption can result from either a blockage (ischemic stroke) or the rupture of a blood vessel (hemorrhagic stroke). The immediate effects of a stroke can lead to significant motor impairments, long-term disability, and profound impacts on mobility, gait, and balance, posing substantial challenges to rehabilitation and overall quality of life. Effective rehabilitation strategies, such as task-oriented gait training and core stabilization exercises, are crucial for improving functional outcomes in stroke patients. Task-oriented gait training emphasizes specific walking tasks to enhance functional mobility, while core stabilization exercises aim to strengthen trunk muscles, thereby improving balance.
This randomized controlled trial (RCT) will involve 54 stroke patients aged 45 to 75 years, determined through OpenEpi, Version 3 sample size calculations. Eligible participants will include individuals who are 6 months to 2 years post-ischemic stroke, have left hemiplegia, possess a Mini-Mental State Examination (MMSE) score of 24 or higher, are able to ambulate independently, and can provide informed consent. Participants will be randomly assigned to one of two groups: Group A will receive task-oriented gait training, while Group B will engage in core stabilization exercises, both administered over an 8-week period with three sessions per week. Outcome measures will include the 6-Minute Walk Test (6MWT) for assessing functional mobility and endurance, the Berg Balance Scale (BBS) for evaluating balance and fall risk, the Gait Assessment and Intervention Tool (GAIT) for gait evaluation, and the Timed Up and Go Test (TUG) for mobility assessment and Patient Satisfaction Survey. Pre- and post-intervention data will be systematically collected to analyze the relative effectiveness of these interventions in post-stroke rehabilitation. Data will be analyzed by SPSS version 25.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Sialkot, Punjab Province, Pakistan, 51310
- Sialkot Medical Complex
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 45 to 75 years
- Diagnosed with ischemic stroke
- Onset of stroke at least 6 months and no more than 2 years prior to enrollment
- Able to ambulate with or without assistive devices
- Mini-Mental State Examination (MMSE) score of 24 or higher
- Experiencing left hemiplegia
- Able to provide informed consent
Exclusion Criteria:
- Other neurological disorders affecting mobility
- Severe musculoskeletal conditions impacting gait or balance
- Uncontrolled medical conditions (e.g., severe cardiovascular issues)
- Major surgery within the last 6 months
- Current participation in other rehabilitation programs
- Contraindications to exercise as determined by a healthcare provider
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: Task-Oriented Gait Training
It focuses on enhancing functional mobility through real-life walking and movement tasks.
The program includes five key exercises: walking practice on flat and uneven surfaces with variations in stride length, speed, and direction; reaching and grasping objects of different sizes and weights from sitting and standing positions; sit-to-stand transitions with minimal arm support; stair navigation with handrail assistance; and object manipulation at varying heights and distances.
Each session is conducted three times per week for eight weeks, emphasizing repetition and progression to simulate daily functional activities.
|
It focuses on enhancing functional mobility through real-life walking and movement tasks.
The program includes five key exercises: walking practice on flat and uneven surfaces with variations in stride length, speed, and direction; reaching and grasping objects of different sizes and weights from sitting and standing positions; sit-to-stand transitions with minimal arm support; stair navigation with handrail assistance; and object manipulation at varying heights and distances.
Each session is conducted three times per week for eight weeks, emphasizing repetition and progression to simulate daily functional activities.
|
|
Experimental: Core Stabilization Exercises
It targets the improvement of balance and postural control through strengthening of trunk muscles.
Participants will perform four core-focused exercises: bridging to activate glutes and lower back muscles, pelvic tilts to improve pelvic control and lumbar alignment, side planks for lateral trunk stability, and quadruped (bird-dog) movements to challenge dynamic balance.
Exercises are performed in sets with specific repetitions or hold times, progressively increasing in difficulty.
The sessions are delivered three times per week for eight weeks to enhance core strength and overall stability in stroke patients.
|
It targets the improvement of balance and postural control through strengthening of trunk muscles.
Participants will perform four core-focused exercises: bridging to activate glutes and lower back muscles, pelvic tilts to improve pelvic control and lumbar alignment, side planks for lateral trunk stability, and quadruped (bird-dog) movements to challenge dynamic balance.
Exercises are performed in sets with specific repetitions or hold times, progressively increasing in difficulty.
The sessions are delivered three times per week for eight weeks to enhance core strength and overall stability in stroke patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-Minute Walk Test (6MWT)
Time Frame: 4 weeks
|
The 6-Minute Walk Test (6MWT) assesses functional mobility and endurance by measuring walking distance in six minutes, with high reliability in stroke patients (ICC > 0.90).
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4 weeks
|
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Berg Balance Scale (BBS)
Time Frame: 4 weeks
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The Berg Balance Scale (BBS) evaluates static and dynamic balance across 14 tasks, serving as a gold standard for fall risk assessment with excellent reliability (ICC = 0.97-0.98).
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4 weeks
|
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Gait Assessment and Intervention Tool (GAIT)
Time Frame: 4 weeks
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The Gait Assessment and Intervention Tool (GAIT) identifies gait abnormalities such as asymmetry and reduced speed, providing targeted insights for gait rehabilitation (ICC = 0.92).
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4 weeks
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Timed Up and Go Test (TUG)
Time Frame: 4 weeks
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The Timed Up and Go Test (TUG) measures functional mobility and fall risk by timing transitional movements, showing strong reliability (ICC = 0.95).
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Ali Hassan Alvi, 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
Other Study ID Numbers
- REC/RCR&AHS/24/0282
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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