- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06459505
Adapted Physical Activities in Hemiplegic Cerebral Palsy
Effects of Adapted Physical Activities in Children With Hemiplegic Cerebral Palsy
The rehabilitation process is critical for people with disabilities, and it appears reasonable to predict that adaptive physical activity will become an important instrument for holistic development in a human rights perspective within an ecological framework. To highlight appropriate physical activity and emphasise its importance as a space for social expression while designing rehabilitation and social inclusion procedures, as well as determining what the lines are and how to approach them. Cerebral palsy (CP) refers to a group of mobility and posture abnormalities caused by non-progressive interference in the growing brain.
This randomised controlled trial will recruit patients using non-probability convenience sampling. Data will be gathered from the Pakistan Society of Rehabilitation Sciences (PSRD) and Behaviour and Special Education Services (BASES). Children diagnosed with hemiplegic cerebral palsy will be included. Patients will be placed into two groups: group 1 will receive an adapted physical activity program, while group 2 will receive conventional care/routine physical therapy. Both groups will receive 30-minute sessions per day, three days a week, for six weeks. The study will use pre- and post-test assessments of patients using the Manual Ability Classification Scale, Gross Motor Function Measure, Goal Attainment Scale, and Lower Extremity Functional Scale.The data will be analysed with SPSS version 25 software.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
GROUP A will receive pre-intervention evaluation that includes baseline measurements using the Manual Ability Classification Scale (MACS), Paediatric Evaluation of Disability Inventory (PEDI), Goal Attainment Scale (GAS), and Lower Extremity Functional Scale (LEFS) at 0 weeks.Participants will receive the modified physical activity program, the experimental group will take part. This program will involve adapted exercises, physical therapy, or modified sports, all aimed at meeting the unique requirements and difficulties faced by people with hemiplegic cerebral palsy and will help them improve their dynamic balance, equilibrium, strength and flexibility. Daily video recordings will be used to collect feedback. Mothers will participate in therapy sessions. Utilizing appropriate assessment instruments and outcome measures, the experimental group's advancement and results will be continuously observed and evaluated. For upper extremity participants will be categorized according to their the MACS level. The levels range from I (able to handle objects easily) to V (limited ability to handle objects). Interventions should be individualized based on the specific needs identified through the MACS assessment. The levels go from I, which is an easy level of object handling, to V, which is a limited degree of object handling. Individualized interventions should be developed in accordance with the unique needs that the MACS evaluation has revealed. Treatment session of 30 minutes per day for three days a week, for six weeks for each participant. After that post-test assessment will be conducted through MACS, PEDI, GAS and LEFS.
Group B will have regular therapy or conventional care that is normally given to people with hemiplegic cerebral palsy. The same evaluation instruments and outcome measures that are used for the experimental group will also be used for the control group's monitoring and assessment. Each participant will receive 30 minutes of treatment three days per week for 6 weeks, spread out over four days of the week. Following that, post-test evaluations using MACS, PEDI, GAS, and LEFS will be carried out.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab, Pakistan
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Lahore, Punjab, Pakistan, Pakistan, 54000
- Riphah International University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with hemiplegic cerebral palsy who have been diagnosed fall within the age range of 7 to 11 years.
- GMFCS will be hired at the I-II level.
- Individuals with steady health conditions
Exclusion Criteria:
- Diseases or traumas that would make physical therapy inappropriate or dangerous.
- Have previously engaged in a comparable program for adaptive physical activity
- Leave out kids who have recently had Botox injections
- Inability to commit to the study protocol or attend scheduled therapy sessions
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 |
|---|---|
|
Active Comparator: Routine or standard Physical Therapy Group
This group will receive routine or conventional physical therapy.
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Participants will undergo physical therapy to stop abnormal movement patterns and restore control over output in the developmental sequence.
Therapists will provide cues to elicit basic posture and movement patterns, inhibiting aberrant patterns.
The therapy aims to promote normal posture and movement patterns, incorporating the hemiplegic side for symmetry and functional use.
Active usage and targeted strengthening activities will be emphasized, with motor performance practice included.
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Experimental: Adapted Physical Activity Group
This group will receive Adapted Physical Activities.
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For Upper extremities, Manual Ability Classification Scale (MACS) is a tool designed to support individuals with hemiplegic cerebral palsy by providing structured support through activities focusing on strength, flexibility, balance, and coordination.
Participants at different MACS levels receive tailored treatments, including adaptive tools, task-specific training, assistive gadgets, and functional training.
For lower extremities, the therapy will begin on stable support surfaces before progressing to more challenging surfaces such as inflatable cushions, foam pads, or balance discs, focusing on slow and controlled motions for improved body alignment and coordination.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Manual Classification Scale of Ability (MACS)
Time Frame: 6 weeks
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This tool was created to categorise people with cerebral palsy according to their manual abilities.
Based on an individual's self-initiated ability to handle objects, it offers a five-level rating system that emphasises hand use throughout daily activities.
Reliability between tests; r = (ICC = 0.984).
Mini-MACS and the Gross Motor Function Classification System were found to be correlated (r = 0.626, 0.596, and 0.598)
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6 weeks
|
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Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame: 6 weeks
|
Use of the Pediatric Evaluation of Disability Inventory (PEDI): This assessment tool assesses children with impairments' performance and functional abilities.
Researchers, therapists, and healthcare professionals frequently utilize the PEDI to evaluate a child's abilities in a variety of daily life domains.
ICC = 0.845-0.938,
Cronbach's alpha = 0.889-0.964
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6 weeks
|
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Goal Attainment Scale (GAS)
Time Frame: 6 weeks
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An outcome measure intended to evaluate how well people accomplish their objectives over the course of a given intervention or treatment period.
It is frequently employed in several industries, such as healthcare, education, and rehabilitation.
GAS is a versatile instrument in evaluating progress towards customised targets since it enables the individualization of goal setting and outcome evaluation.
Reliability between and within testers (ICC=0.98)
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6 weeks
|
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Lower Extremity Functional Scale (LEFS):
Time Frame: 6 weeks
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Frequently use to evaluate the functional status of patients with musculoskeletal disorders of the lower extremities.
It is frequently used to gauge a person's capacity for carrying out different tasks linked to lower limb function in orthopaedic and physical therapy settings.
The LEFS often asks about a person's capacity for carrying out routine tasks including running, jumping, walking, and stair climbing.
The overall functional status of the lower extremities is assessed using the ratings that respondents provide on a scale for each activity.
Intraclass correlation values (ICC=0.85-0.99)
and Pearson correlation=(>0.7)
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6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maryam Mangrio, MS*, Riphah International University
Publications and helpful links
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
- REC/RCR & AHS/23/0789
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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