LIFT & PEDALS on Balance and Mobility in Children With CP

NCT ID: NCT06996028

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-07-15

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.

Conditions

CP

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Strengthening domain, Balance domain, Coordination domain, Gait domain

Intervention Type: OTHER

The 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

Intervention Type: OTHER

Group 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.

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.

Group Type: EXPERIMENTAL

Strengthening domain, Balance domain, Coordination domain, Gait domain

Intervention Type: OTHER

The 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

Intervention Type: OTHER

Group 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.

Interventions

Strengthening domain, Balance domain, Coordination domain, Gait domain

The 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.

Intervention Type: OTHER

Lower extremity strengthening, Cardiorespiratory endurance

Group 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aniqa Feroz, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Muhammad Asif Javed

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

IMRAN AMJAD, PHD

Role: CONTACT

imran.amjad@riphah.edu.pk

92332224390125

Muhammad Asif Javed, MS-PT

Role: CONTACT

a.javed@riphah.edu.pk

923224209422

Facility Contacts

imran Javed, PHD

Role: primary

imran.amjad@riphah.edu.pk

9233224390125

Muhammad Asif javed, MS-PT

Role: backup

a.javed@riphah.edu.pk

923224209422

References

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.

Reference Type: BACKGROUND

PMID: 35224682 (View on PubMed)

Other Identifiers

REC/RCR/AHS/25/aniqa feroz

Identifier Type: -

Identifier Source: org_study_id