LIFT & PEDALS on Balance and Mobility in Children With CP

NCT06996028 | Recruiting DMC

• 1 other identifier: REC/RCR/AHS/25/aniqa feroz
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

CP

Keywords

CP; LIFT; 6 min walk test; GMF88

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 4th week, 6th week

• 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).

  Baseline, 4th week, 6th week

Study Arms (2)

Group A

EXPERIMENTAL

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.

Other: Strengthening domain, Balance domain, Coordination domain, Gait domain; Other: Lower extremity strengthening, Cardiorespiratory endurance

Group B

EXPERIMENTAL

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.

Other: Strengthening domain, Balance domain, Coordination domain, Gait domain; Other: Lower extremity strengthening, Cardiorespiratory endurance

Interventions

Strengthening domain, Balance domain, Coordination domain, Gait domain 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.

Group A; Group B

Lower extremity strengthening, Cardiorespiratory endurance 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 A; Group B

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Muhammad Asif Javed

Lahore, Punjab Province, 54900, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 35224682 BACKGROUND

Study Officials

• Aniqa Feroz, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IMRAN AMJAD, PHD

CONTACT

92332224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 15, 2025
• Primary Completion: June 29, 2025
• Study Completion: July 15, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)