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

NCT07173647 | Completed DMC

• 1 other identifier: UOL/IREB/25/09/0041
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy (CP)

Keywords

Pediatric Rehabilitation; Electrical Muscle Stimulation (EMS); Strength Training; Endurance Training; Balance and Gait; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Timed Up and Go

  Time (seconds) to stand from a chair, walk 3 meters, turn, return, and sit. Lower times indicate better mobility. Used to determine whether the PEDAL program with or without electrical muscle stimulation produces greater improvement in functional mobility.

  Baseline to 4 weeks

Secondary Outcomes (1)

• Gait Outcomes Assessment List

  Baseline to 4 weeks

Other Outcomes (1)

• Berg Balance Scale

  Baseline to 4 weeks

Study Arms (2)

PEDAL Program with Electrical Muscle Stimulation

EXPERIMENTAL

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.

Device: PEDAL Program with Electrical Muscle Stimulation

PEDAL Program without Electrical Muscle Stimulation

ACTIVE COMPARATOR

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.

Behavioral: PEDAL Program without Electrical Muscle Stimulation

Interventions

PEDAL Program with Electrical Muscle Stimulation 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 with Electrical Muscle Stimulation

PEDAL Program without Electrical Muscle Stimulation 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).

PEDAL Program without Electrical Muscle Stimulation

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

Related Publications (10)

• Naro A, Leo A, Russo M, Casella C, Buda A, Crespantini A, Porcari B, Carioti L, Billeri L, Bramanti A, Bramanti P, Calabro RS. Breakthroughs in the spasticity management: Are non-pharmacological treatments the future? J Clin Neurosci. 2017 May;39:16-27. doi: 10.1016/j.jocn.2017.02.044. Epub 2017 Mar 3.

  PMID: 28262404 RESULT

• Ferrari A. From movement to action: a new framework for cerebral palsy. Eur J Phys Rehabil Med. 2019 Dec;55(6):852-861. doi: 10.23736/S1973-9087.19.05845-3. Epub 2019 Sep 24.

  PMID: 31556512 RESULT

• Downs (2015) reviewed the Berg Balance Scale, emphasizing its importance in physiotherapy practice.

  RESULT

• Divita (2024) investigated the effects of high- versus low-frequency whole body vibration on TUG, BBS, and walking performance in chronic stroke patients.

  RESULT

• Christensen et al. (2019) compared TUG performance in pregnant women with pelvic girdle pain to asymptomatic pregnant and non-pregnant women.

  RESULT

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

  RESULT

• Bartels EM, Korbo L, Harrison AP. Novel insights into cerebral palsy. J Muscle Res Cell Motil. 2020 Sep;41(2-3):265-267. doi: 10.1007/s10974-020-09577-4.

  PMID: 32065339 RESULT

• Armstrong EL, Spencer S, Kentish MJ, Horan SA, Carty CP, Boyd RN. Efficacy of cycling interventions to improve function in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Clin Rehabil. 2019 Jul;33(7):1113-1129. doi: 10.1177/0269215519837582. Epub 2019 Apr 2.

  PMID: 30935240 RESULT

• 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.

  PMID: 33146438 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study will be conducted as an open-label randomized clinical trial. Due to the nature of the interventions, neither the participants nor the treating physiotherapists can be masked to group allocation. However, to reduce the risk of bias, outcome assessments will be performed by an independent assessor who will not be informed of the group assignments. This approach ensures that data collection remains objective while allowing the interventions to be delivered appropriately.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: Model Description:This study follows a parallel assignment design in which participants are randomly allocated into two groups. Group A will receive the Pediatric Endurance and Limb Strengthening (PEDAL) program combined with Electrical Muscle Stimulation (EMS), while Group B will receive the PEDAL program without EMS. Both groups will be treated and assessed in parallel over the 4-week intervention period

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 15, 2025
• Study Start: November 25, 2024
• Primary Completion: May 25, 2025
• Study Completion: June 25, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)