Adapted Physical Activities in Hemiplegic Cerebral Palsy

October 28, 2024 updated by: Riphah International University

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

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

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab, Pakistan
      • Lahore, Punjab, Pakistan, Pakistan, 54000
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
Experimental: Adapted Physical Activity Group
This group will receive Adapted Physical Activities.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manual Classification Scale of Ability (MACS)
Time Frame: 6 weeks
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)
6 weeks
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
6 weeks
Goal Attainment Scale (GAS)
Time Frame: 6 weeks
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)
6 weeks
Lower Extremity Functional Scale (LEFS):
Time Frame: 6 weeks
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)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maryam Mangrio, MS*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2024

Primary Completion (Actual)

August 15, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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