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Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program VS Task-Oriented Training (TOT) Improving Gross Motor Function in Children With Cerebral Palsy

S

Shalamar Institute of Health Sciences

Status

Not yet enrolling

Conditions

Cerebral Palsy

Treatments

Other: Pediatric Endurance and Limb Strengthening (PEDALS) program
Other: Task-Oriented Training (TOT)

Study type

Interventional

Funder types

Other

Identifiers

NCT06479395
ShalamarIHS-722

Details and patient eligibility

About

To compare the Effects of Pediatric endurance and limb strengthening (PEDALS) program VS Task-oriented Training (TOT) improving gross motor function among children with Cerebral Palsy.

Full description

By integrating the Pediatric endurance and limb strengthening (PEDALS) exercises and Task Oriented training children can engage in more comprehensive therapy that simultaneously targets muscle strengthening, coordination and balance with in a context that stimulates real life activities. Task Oriented Training interventions can promote neural plasticity through repetitive task specific practice. It will have marked impact on improvement of ADLS in CP community. This study will play a vital role in improving the mobility of CP community. Hence improving the gross motor functions i.e. facilitating the CP child being more independent in sitting standing jumping and running.

Enrollment

20 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • • Diplegic Cerebral Palsy children

    • Gross motor classification system level 1and level 2.
    • Age 6 to 12 years.
    • Male and female are included.

Exclusion criteria

  • • Individuals with co-existing medical conditions that significantly impact motor function other than CP.

    • Participants who are unable to engage in the assigned interventions due to physical or cognitive limitations.
    • Gross motor classification system level 3.4 and 5.
    • Any contraindications to the assigned interventions, such as severe motion sickness or contraindications to physical exercise for pedal training.
    • Previous participation in similar interventions within a defined timeframe to avoid potential confounding effects.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Pediatric Endurance and Limb Strengthening (PEDALS) program
Experimental group
Description:
Phase 1: lower-extremity strengthening: Resistance will be progressed to the next higher cord when 10 revolutions will be performed in a smooth pattern while keeping the seat within the desired zone. Phase 2: cardiorespiratory endurance: The goal of this phase is to gradually increase duration and intensity. The seat will be locked in a location that will position the participants knee in 15 to 20 degrees of flexion. The exercise duration goal will be 15 to 30 minutes. A cool down period consists of pedaling without resistance until heart rate (HR) decreases to within 20 bpm.(11)
Treatment:
Other: Pediatric Endurance and Limb Strengthening (PEDALS) program
Task-Oriented Training (TOT)
Active Comparator group
Description:
The task-oriented training will focus on lower extremity strengthening comprised of the following: 1) The subjects will maintain a standing position for three seconds 2) The subjects will stand on one leg for three seconds while holding a chair with one hand 3) The subjects will stand up from a chair without using their arms 4) The subjects will stand up from a half kneeling position without using their arms 5) The subjects will kick a ball 6) The subjects has to climb up and climbed down four steps. All treatment procedures will be implemented for 40 minutes, thrice a week, for a total of eight weeks per session. including rest periods. The number of repetitions will be increased every 2 weeks up to a maximum of 15 repetitions if the participants will able to perform the training easily. (4)
Treatment:
Other: Task-Oriented Training (TOT)

Trial contacts and locations

1

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Central trial contact

Dr.Sadaf Tabasum Tabassum, MS.OMPT; Ammana Saeed, DPT

Data sourced from clinicaltrials.gov

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