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

NCT ID: NCT07173647

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2025-06-25

Brief 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.

Detailed Description

Cerebral palsy (CP) is a predominant cause of childhood impairment, characterized by diminished strength, decreased endurance, inadequate postural control, and restrictions in movement and mobility. Rehabilitation regimens emphasizing endurance and limb strengthening have demonstrated beneficial impacts on motor performance and functional independence in this demographic. Nonetheless, voluntary muscular activation in children with cerebral palsy is frequently constrained, potentially diminishing the efficacy of traditional exercise regimens. Electrical muscle stimulation (EMS) has been implemented as a supplementary method to augment muscle recruitment, reduce stiffness, and enhance neuromuscular control. This trial will examine the Pediatric Endurance and Limb Strengthening (PEDAL) program, both with and without Electrical Muscle Stimulation (EMS), in children diagnosed with cerebral palsy. The PEDAL program employs cycling-based training aimed at enhancing aerobic endurance and lower-limb strength, integrating increasing resistance and functional task elements. In the intervention group, electrical muscle stimulation (EMS) will be administered to the quadriceps muscles during exercise to enhance contractions and potentially increase the training benefits. The study aims to determine if the integration of EMS with endurance and strength training yields superior enhancements in balance, gait, and mobility compared to exercise alone. This project aims to enhance the evidence foundation for pediatric neurorehabilitation, perhaps facilitating the incorporation of EMS-assisted exercise into standard physiotherapy for children with cerebral palsy to optimize motor results and independence.

Conditions

Cerebral Palsy (CP)

Study Design

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

Study Groups

PEDAL Program with Electrical Muscle Stimulation

Participants in this group will receive the Pediatric Endurance and Limb Strengthening (PEDAL) program combined with electrical muscle stimulation (EMS) applied to the quadriceps muscles during stationary cycling exercises. Each session will last 60 minutes, three times per week for four weeks, and will include warm-up, strengthening and endurance cycling, and cool-down stretching. EMS parameters will follow established clinical guidelines for strength and endurance training.

Group Type: EXPERIMENTAL

PEDAL Program with Electrical Muscle Stimulation

Intervention Type: DEVICE

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

PEDAL Program without Electrical Muscle Stimulation

Participants in this group will receive the Pediatric Endurance and Limb Strengthening (PEDAL) program only, without electrical muscle stimulation. The program will also be delivered using stationary cycling for 60 minutes per session, three times per week for four weeks, with warm-up, strengthening and endurance cycling, and cool-down stretching, following the same protocol as the intervention group but without EMS.

Group Type: ACTIVE_COMPARATOR

PEDAL Program without Electrical Muscle Stimulation

Intervention Type: BEHAVIORAL

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).

Interventions

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

Intervention Type: DEVICE

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children from 6 to 10 years old
• Both gender
• Participant with spastic cerebral palsy
• Children who can easily follow verbal directions
• Participant with good and fair one lower limb selective motor control
• Participant who can walk independently
• Participant who lies between 1 to 2 levels of Gross motor function
• People who are willing to participate

Exclusion Criteria

• Participant who had gone under any neurological surgery, orthopedic surgery or bachlofen pump implant in previous year
• Participant who had serial casting or who use any new orthotics from last 3 months
• Participant with involvement in any exercise, physical therapy, or any sports proceeding within last three months
• Participant who had any serious medical condition like diabetes, seizure, or any cardiac disease
• Participant who are involved in any fitness program that can improve cardio respiratory endurance

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Maryam Iqbal

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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Reference Type: RESULT

Cho et al. (2019) developed a dual-mode feedback-controlled cycling system designed for upper limb rehabilitation in children with cerebral palsy.

Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Armstrong EL, Boyd RN, Horan SA, Kentish MJ, Ware RS, Carty CP. Functional electrical stimulation cycling, goal-directed training, and adapted cycling for children with cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2020 Dec;62(12):1406-1413. doi: 10.1111/dmcn.14648. Epub 2020 Aug 9.

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Anwar, A., Waheed, F., Javaid, A., Zahoor, I. A., Malik, A. N., & Abbas, R. (2023). Normative Values of Berg Balance Scale and Timed Up and Go Test in Elderly Females; A Descriptive Study: Berg Balance Scale in Elderly Females. The Healer Journal of Physiotherapy and Rehabilitation Sciences, 3(6), 617-626.

Reference Type: RESULT

Other Identifiers

UOL/IREB/25/09/0041

Identifier Type: -

Identifier Source: org_study_id