Clinical trial NCT05903534: Effects of PEDALS Program Versus Lower Limb Strength Training in Diplegic CP
Official title: Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program Versus Lower Limb Strength Training in Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy,Diplegic
Keywords: Cerebral palsy, endurance, strength, training, pediatric
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Its a randomized control trial, used to evaluate the comparative effects of pediatric endurance and limb strengthening program with lower limb strength training in diplegic cerebral palsy. Subjects with diplegic cerebral palsy (GMFCS level 1-11) meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is a neurodevelopmental disorder is caused by damage to the developing brain and is characterized by abnormalities of muscle tone, mobility, and motor abilities. CP may only be recognized at 3-5 years of age. Pediatric endurance and limb strengthening (PEDALS) program is important to achieve endurance, gross motor function and some measure of strength in patients with diplegic cerebral palsy. The aim of this study is to evaluate the comparative effects of pediatric endurance and limb strengthening program with lower limb strength training in diplegic cerebral palsy.

Detailed description: A randomized control trial will be conducted through convenient sampling. Subjects will randomly allocated into two groups, group A will receive pediatric endurance and limb strengthening program, while group B will receive lower limb strength training. The duration of the treatment will be 8 weeks. Goniometer, six minute walk test and gross motor function measure scale-88 will be used to as outcome measure. Goniometer measures the available range of motion at a joint, six minute walk test measure cardiorespiratory or aerobic endurance, the GMFM-88 provides more descriptive information about motor function for very young children or children with more complex motor disability, Data will be analyzed on SPSS version 27, normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.

Eligibility criteria: * Inclusion Criteria: •

  * Age between 6-12 years of age, children with cerebral palsy
  * Ability to follow simple verbal direction
  * Ability to walk independently with or without an assistive device for short distance (GMFCS) level 1-11
  * Good or fair selective voluntary motor control for at least one limb

Exclusion Criteria:

* Orthopedic surgery
* Botulinum toxin injection within the preceding 3 months
* Serial casting or new orthotic devices within the preceding 3 months
* Initiation of oral medication that effect the neuromuscular system
* Significant hip, knee or ankle joint contractures
* Inability of unwillingness to maintain age- appropriate behavior

Primary outcomes:
measure: Goniometer
timeFrame: 8 weeks
measure: Gross motor function measure 88
timeFrame: 8 weeks
measure: Six minute walk test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Iqra Mahnoor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fowler EG, Knutson LM, Demuth SK, Siebert KL, Simms VD, Sugi MH, Souza RB, Karim R, Azen SP; Physical Therapy Clinical Research Network (PTClinResNet). Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):367-81. doi: 10.2522/ptj.20080364. Epub 2010 Jan 21.