Comparative Effects of (LIFT) Lower-extremity Functional Training and (PEDALS) Pediatric Endurance and Limb Strengthening on Balance and Mobility in Children With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 6 MINUTE WALK TEST FOR ENDURANCE
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group A
The experimental group will follow the LIFT (Lifestyle Intervention for Function and Training) program, which includes exercises across four domains: strengthening (sit-to-stand, step-ups, vertical jumping, stair climbing), balance (tandem walking, one-leg standing, balancing on unstable surfaces), gait (bridging, clamshells, heel rises), and coordination (ball kicking, hopping through squares, galloping/skipping). The training will be conducted for 2 hours per day, 5 days a week, over 6 weeks . Each 2-hour session can be divided into two 1-hour sessions or four 30-minute sessions.
Intervention: Strengthening domain, Balance domain, Coordination domain, Gait domain (Other)
Group A
The experimental group will follow the LIFT (Lifestyle Intervention for Function and Training) program, which includes exercises across four domains: strengthening (sit-to-stand, step-ups, vertical jumping, stair climbing), balance (tandem walking, one-leg standing, balancing on unstable surfaces), gait (bridging, clamshells, heel rises), and coordination (ball kicking, hopping through squares, galloping/skipping). The training will be conducted for 2 hours per day, 5 days a week, over 6 weeks . Each 2-hour session can be divided into two 1-hour sessions or four 30-minute sessions.
Intervention: Lower extremity strengthening, Cardiorespiratory endurance (Other)
Group B
Experimental Group (Group B): The PEDALS program involves stationary cycling three times a week for 30 minutes per session, divided into two phases. Phase 1 focuses on lower-limb strengthening, where participants are properly positioned on the bike and encouraged to pedal with increasing resistance as tolerated. Phase 2 targets cardiorespiratory endurance, aiming to gradually increase cycling duration to 15-30 minutes, followed by a cool-down with low-intensity pedaling until heart rate returns close to baseline.
Intervention: Strengthening domain, Balance domain, Coordination domain, Gait domain (Other)
Group B
Experimental Group (Group B): The PEDALS program involves stationary cycling three times a week for 30 minutes per session, divided into two phases. Phase 1 focuses on lower-limb strengthening, where participants are properly positioned on the bike and encouraged to pedal with increasing resistance as tolerated. Phase 2 targets cardiorespiratory endurance, aiming to gradually increase cycling duration to 15-30 minutes, followed by a cool-down with low-intensity pedaling until heart rate returns close to baseline.
Intervention: Lower extremity strengthening, Cardiorespiratory endurance (Other)
Outcomes
Primary Outcomes
6 MINUTE WALK TEST FOR ENDURANCE
Time Frame: Baseline, 4th week, 6th week
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.
PEDIATRIC BALANCE SCALE(BBS)
Time Frame: Baseline, 4th week, 6th week
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).
Secondary Outcomes
No secondary outcomes reported