Clinical trial NCT06479395: Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program VS Task-Oriented Training (TOT) Improving Gross Motor Function in Children With Cerebral Palsy
Official title: Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program VS Task-Oriented Training (TOT) Improving Gross Motor Function in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Task-Oriented Training (TOT)
Pediatric Endurance and Limb Strengthening (PEDALS)
gross motor function (GMF)
Lead sponsor: Shalamar Institute of Health Sciences
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: gross motor function
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Rising Sun institute for Special children Mughalpura campus Lahore
state: Punjab
Study officials:
References:
citation: 1. Dimitrijevic L. Management of cerebral palsy through the childhood: How does it work in Serbia? Preventive Paediatrics. 2024:039-44. 2. Bekteshi S, Monbaliu E, McIntyre S, Saloojee G, Hilberink SR, Tatishvili N, et al. Towards functional improvement of motor disorders associated with cerebral palsy. The Lancet Neurology. 202322(3):229-43. 3. Hasan AB, Mohamed NE, El-Sheikh AF. PEDALING EXERCISE AS A REHABILITATION FOR CHILDREN WITH CEREBRAL PALSY (A REVIEW ARTICLE). 4. Ko EJ, Sung IY, Moon HJ, Yuk JS, Kim H-S, Lee NH. Effect of group-task-oriented training on gross and fine motor function, and activities of daily living in children with spastic cerebral palsy. Physical & Occupational Therapy In Pediatrics. 202040(1):18-30. 5. Armstrong EL, Spencer S, Kentish MJ, Horan SA, Carty CP, Boyd RN. Efficacy of cycling interventions to improve function in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Clinical rehabilitation. 201933(7):1113-29. 6. Dussault-Picard C, Pouliot-Laforte A, Cherriere C, Houle E, Ballaz L. Locomotion Efficiency in Children With Cerebral Palsy Experiencing Limited Gross Motor Function: Walking Versus Cycling. Pediatric Physical Therapy. 202436(2):274-7. 7. Zai W, Xu N, Wu W, Wang Y, Wang R. Effect of task-oriented training on gross motor function, balance and activities of daily living in children with cerebral palsy: A systematic review and meta-analysis. Medicine. 2022101(44):e31565. 8. Madeshwaran S. A Study on the Effectiveness of Task Oriented Strength Training to Enhance Upper Limb Motor Function in Children with Cerebral Palsy. Indian Journal of Physiotherapy & Occupational Therapy. 202418. 9. Ghani HM, Razzaq M, Safdar N, Umer B, Tariq F. Effects of Stationary Cycling on Spasticity and Range of Motion in Children with Diplegic Cerebral Palsy: A Quasi Interventional Study. Foundation University Journal of Rehabilitation Sciences. 20211(1):24-8. 10. Mazumdar C. Effect of task-oriented training on motor function in children with cerebral palsy: a systemic review: Lietuvos sporto universitetas. 2021. 11. Demuth SK, Knutson LM, Fowler EG. The PEDALS stationary cycling intervention and health-related quality of life in children with cerebral palsy: A randomized controlled trial. Developmental Medicine & Child Neurology. 201254(7):654-61.