Adapted Physical Activities in Hemiplegic Cerebral Palsy

NCT06459505 | Completed

• 1 other identifier: REC/RCR & AHS/23/0789
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegic Cerebral Palsy

Keywords

Cerebral Palsy, Hemiplegia , Adapted Physical Activities.

Outcome Measures

Primary Outcomes (4)

• Manual Classification Scale of Ability (MACS)

  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)

  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)

  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):

  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

Study Arms (2)

Routine or standard Physical Therapy Group

ACTIVE COMPARATOR

This group will receive routine or conventional physical therapy.

Other: Routine or standard Physical Therapy

Adapted Physical Activity Group

EXPERIMENTAL

This group will receive Adapted Physical Activities.

Other: Adapted Physical Activity

Interventions

Routine or standard Physical Therapy OTHER

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.

Routine or standard Physical Therapy Group

Adapted Physical Activity OTHER

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.

Adapted Physical Activity Group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab, Pakistan, 54000, Pakistan

Location

Related Publications (1)

• Sit C, Aubert S, Carty C, Silva DAS, Lopez-Gil JF, Asunta P, Palad Y, Guisihan R, Lee J, Arbour Nicitopoulos KP, Vanderloo LM, Stanish H, Haegele J, Urbanski PK, Pozeriene J, Hutzler Y, Ng K. Promoting Physical Activity Among Children and Adolescents With Disabilities: The Translation of Policy to Practice Internationally. J Phys Act Health. 2022 Oct 22;19(11):758-768. doi: 10.1123/jpah.2022-0351. Print 2022 Nov 1.

  PMID: 36280232 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maryam Mangrio, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment It will be Randomized control trial in which non probabilty convenient sampling will be used. Two groups of 7-11 age will be formed in which participants will be randomly divided. Group A will Adapted Physical Activities and group B will only receive conventional Physical Therapy used for hemiplegic cerebral palsy.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 30, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)