LIFT & PEDALS on Balance and Mobility in Children With CP
ConditionCP
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorRiphah International University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Strengthening domain, Balance domain, Coordination domain, Gait domain
Other interventionThe experimental group will engage in a structured exercise program targeting strength, balance, gait, and coordination. Strength exercises include sit-to-stand, step-ups, vertical jumping, and stair climbing. Balance training involves tandem walking, one-leg standing, and balancing on unstable surfaces. Gait exercises include bridging, clamshells, and heel rises, while coordination activities involve ball kicking, hopping through squares, and galloping/skipping. The program runs for 2 hours per day, 5 days a week, over 6 weeks, with sessions optionally split into shorter segments.
Lower extremity strengthening, Cardiorespiratory endurance
Other interventionGroup B will follow the PEDALS program, involving stationary cycling three times a week for 30 minutes per session. Each session includes lower-limb strengthening with gradual resistance progression and cardiorespiratory endurance training aimed at increasing cycling duration to 15-30 minutes. Proper bike setup and participant support are ensured, and each session ends with a cool-down period of pedaling without resistance until heart rate returns near baseline.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Group AExperimental treatment 2 interventions
Group B: Group BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
6 MINUTE WALK TEST FOR ENDURANCE
The Six-Minute Walk Test (6MWT), introduced by the American Thoracic Society in 2002, is a submaximal test used to assess aerobic capacity and endurance by measuring the distance walked in six minutes.
Time frame
Baseline, 4th week, 6th week2
PEDIATRIC BALANCE SCALE(BBS)
The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale, to assess balance in school-age children with mild to moderate motor impairments. The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale, designed to assess balance in school-age children with mild to moderate motor impairments. It has demonstrated strong reliability and validity, with an intraobserver ICC of 0.927, a Cronbach's alpha of 0.857, and a concurrent validity of r = 0.692 (p \< 0.0005). The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale, designed to assess balance in school-age children with mild to moderate motor impairments. It has demonstrated strong reliability and validity, with an intraobserver ICC of 0.927, a Cronbach's alpha of 0.857, and a concurrent validity of r = 0.692 (p \< 0.0005).
Time frame
Baseline, 4th week, 6th weekSponsors and contacts
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Source ClinicalTrials.gov