Clinical trial NCT06996028: LIFT & PEDALS on Balance and Mobility in Children With CP
Official title: Comparative Effects of (LIFT) Lower-extremity Functional Training and (PEDALS) Pediatric Endurance and Limb Strengthening on Balance and Mobility in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CP
Keywords: CP
LIFT
6 min walk test
GMF88
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 20
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: A Randomized clinical trial performed,in which 20 CP children with the age of 6-12 years will be taken randomly after screening and meeting inclusion criteria. Children will be divided in two groups. Group 1 will receive LIFT for 2 hours 5 days a week. Group 2 will receive PEDALS for 2 hours 5 days a week. Pre values were taken at 1st week and then after 4th week mid values of interventions will be taken and post values of intervention will be taken after 6 weeks of intervention to measure the effects of both therapies.
Primary purpose: OTHER

Brief summary: Children with cerebral palsy (CP) have impaired balance due to poor postural control and coordination, increasing fall risk and limiting daily activities. This randomized controlled trial aims to compare the effects of Lower-Extremity Functional Training (LIFT) and Pediatric Endurance and Limb Strengthening (PEDALS) on balance and mobility in children with diplegic CP. A total of 22 children (ages 6-12) from Adil Special School, Sargodha, will be randomly assigned to two groups. One group will perform exercises targeting strength, coordination, gait, and balance; the other will perform pedaling exercises. Pre- and post-intervention assessments will include the 6-Minute Walk Test, GMFM-88, and Pediatric Balance Scale. Data will be analyzed using SPSS 23

Detailed description: Balance in children with CP is impaired by poor postural control mechanism. Earlier studies on balance have found that children with CP had poor static and dynamic balance reactions than those of typically developing children . These balance problems increase risk of falls, which further affected children with cerebral palsy in performance of activities of daily living mobility and participation. Cerebral palsy also causes coordination problems. Brain can not properly send messages to muscles about how to move in smooth and well coordinated ways. The aim of the study is to analyse comparative effects of (LIFT) lower-extremity functional training and (PEDALS) pediatric endurance and limb strenghtening on balance and mobility in children with cerebral palsy The current study will be randomized control trial; data will be collected from Sargodha Adil Special School and Rehabilitation Centre.The study will include 22 patients equally divided in two groups and randomly allocated. Inclusion criteria for the study will be ability to walk independently, ability to follow 2-step instructions and complete testing. Age between 6 and 12 years. Ability to participate in group training program and children with diplegic cerebral palsy. Patients with cognitive delay,visual problems. Seizures, or if there is change in medication will be expected during the study or if patient is suffering from disease that interfered with physical activity will be excluded from the study. One experimental group will perform 4 domains of exercises (strengthening, coordination, gait and balance). In second experimental group pedalling exercise will be performed. Data collection will be done before and after intervention. Tools used for data collection will be 6 minute walk test, GMFM88, Pediatric balance scale. Data will be analysed through SPSS version 23.00.

Eligibility criteria: Inclusion Criteria:

* Gross Motor Function Classification System level of I to II
* Ability to follow 2-step instructions and complete testing.
* Age between 6 and 12 years.
* Children with cerebral palsy

Exclusion Criteria:

* Cognitive delay preventing 2-step instructions
* Visual problem preventing performance of interventions.
* Caregivers unable to commit to duration of intervention.
* If patient had unstable seizures.
* If any change in medication was expected during the study.

Primary outcomes:
measure: 6 MINUTE WALK TEST FOR ENDURANCE
timeFrame: Baseline, 4th week, 6th week
measure: PEDIATRIC BALANCE SCALE(BBS)
timeFrame: Baseline, 4th week, 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Muhammad Asif Javed
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aniqa Feroz, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biyik KS, Gunel MK, Akyuz EU. How does treadmill training contribute to botulinum toxin application plus routine physical therapy in ambulatory children with spastic bilateral cerebral palsy? A randomized controlled trial. Ir J Med Sci. 2023 Feb;192(1):209-217. doi: 10.1007/s11845-022-02960-9. Epub 2022 Feb 27.