Clinical trial NCT06459505: Adapted Physical Activities in Hemiplegic Cerebral Palsy
Official title: Effects of Adapted Physical Activities in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: Cerebral Palsy, Hemiplegia , Adapted Physical Activities.
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 24
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Manual Classification Scale of Ability (MACS)
timeFrame: 6 weeks
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: 6 weeks
measure: Goal Attainment Scale (GAS)
timeFrame: 6 weeks
measure: Lower Extremity Functional Scale (LEFS):
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab, Pakistan
Study officials:
affiliation: Riphah International University
name: Maryam Mangrio, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.