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Pediatric Endurance and Limb Strengthening Program With and Without Electrical Muscle Stimulation Among Children With Cerebral Palsy

NCT07173647 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-11-28

No results posted yet for this study

Summary

This randomized clinical research will assess the impact of a Pediatric Endurance and Limb Strengthening (PEDAL) program, both with and without Electrical Muscle Stimulation (EMS), on balance, gait, and mobility in children diagnosed with cerebral palsy. A total of 26 individuals will be recruited via purposive sampling and randomly allocated to two groups utilizing the sealed envelope method. Group A will undergo the PEDAL program in conjunction with electrical muscle stimulation (EMS) administered to the quadriceps during stationary cycling, whereas Group B will participate in the PEDAL program exclusively, without EMS. Both groups will participate in supervised sessions three times weekly for four weeks, with each session lasting 60 minutes and comprising a warm-up, cycling-based strength and endurance training, and cool-down stretches. EMS parameters will be implemented in accordance with published protocols for strength (30-80 Hz, 150-350 μs) and endurance (8-35 Hz, 150-250 μs) training. Outcome measures, comprising the Berg Balance Scale, Timed Up and Go Test, and Gait Outcomes Assessment List (GOAL™️) questionnaire, will be evaluated at baseline and following four weeks of intervention. The data will be examined utilizing SPSS version 27. This study aims to determine whether incorporating EMS into a structured pediatric strengthening and endurance regimen yields greater improvements in motor function compared to exercise alone.

Conditions

  • Cerebral Palsy (CP)

Interventions

DEVICE

PEDAL Program with Electrical Muscle Stimulation

Electrical Muscle Stimulation (EMS) will be applied to the quadriceps muscles of children with cerebral palsy during stationary cycling sessions as part of the Pediatric Endurance and Limb Strengthening (PEDAL) program. EMS will be delivered using clinically approved portable stimulators at parameters appropriate for muscle strengthening and endurance training (frequency 35-50 Hz, pulse width 200-400 μs, duty cycle on/off as tolerated). EMS will be administered simultaneously with cycling to enhance muscle activation and improve motor outcome

BEHAVIORAL

PEDAL Program without Electrical Muscle Stimulation

The PEDAL program is a structured exercise intervention designed for children with cerebral palsy. It includes 60-minute sessions of stationary cycling, warm-up, endurance and limb strengthening exercises, and cool-down stretching. Sessions are conducted three times per week for four weeks under therapist supervision. This program is used in both arms of the trial, with or without adjunct Electrical Muscle Stimulation (EMS).

Sponsors & Collaborators

  • University of Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2025-05-25
Completion
2025-06-25

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07173647 on ClinicalTrials.gov