Cerebral Palsy (CP)NCT07173647
Pediatric Endurance and Limb Strengthening Program With and Without Electrical Muscle Stimulation Among Children With Cerebral Palsy
A study testing PEDAL Program with Electrical Muscle Stimulation and PEDAL Program without Electrical Muscle Stimulation in people with Cerebral Palsy (CP), run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- PEDAL Program with Electrical Muscle Stimulation and PEDAL Program without Electrical Muscle Stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Nov 2024to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province
About this study
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.
Read the 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)
- Being tested
- PEDAL Program with Electrical Muscle Stimulation, PEDAL Program without Electrical Muscle Stimulation
- Keywords
- Pediatric Rehabilitation, Electrical Muscle Stimulation (EMS), Strength Training, Endurance Training, Balance and Gait, Neurorehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEDAL Program with Electrical Muscle StimulationDevice
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 StimulationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: PEDAL Program without Electrical Muscle Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 weeks
Secondary outcomes (1)
Gait Outcomes Assessment List
Parent-reported questionnaire assessing gait-related function and participation in children with cerebral palsy. Higher scores indicate better function.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start25 Nov 2024
- Primary completion25 May 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Iqbal, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173647
- Sponsor's protocol ID
- UOL/IREB/25/09/0041
- Status last verified
- Nov 2025
- First submitted
- 7 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28262404Ferrari 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.
PubMed 31556512Downs (2015) reviewed the Berg Balance Scale, emphasizing its importance in physiotherapy practice.
Divita (2024) investigated the effects of high- versus low-frequency whole body vibration on TUG, BBS, and walking performance in chronic stroke patients.
Christensen et al. (2019) compared TUG performance in pregnant women with pelvic girdle pain to asymptomatic pregnant and non-pregnant women.
Cho et al. (2019) developed a dual-mode feedback-controlled cycling system designed for upper limb rehabilitation in children with cerebral palsy.
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.
PubMed 32065339Armstrong 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.
PubMed 30935240Armstrong 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.
PubMed 33146438Anwar, 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Endurance and Limb Strengthening Program With and Without Electrical Muscle Stimulation Among Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07173647
- Acronym / sponsor ID
- UOL/IREB/25/09/0041
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Pediatric Rehabilitation, Electrical Muscle Stimulation (EMS), Strength Training, Endurance Training, Balance and Gait, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| PEDAL Program with Electrical Muscle Stimulation | Experimental | Device: PEDAL Program with Electrical Muscle StimulationParticipants 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. |
| PEDAL Program without Electrical Muscle Stimulation | Active comparator | Behavioral: PEDAL Program without Electrical Muscle StimulationParticipants 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEDAL Program with Electrical Muscle StimulationElectrical 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 | Device | PEDAL Program with Electrical Muscle Stimulation |
| PEDAL Program without Electrical Muscle StimulationThe 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). | Behavioural | PEDAL Program without Electrical Muscle Stimulation |
Primary outcome
Timed Up and Go
Time frame: Baseline to 4 weeks
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.
1 secondary outcome
Gait Outcomes Assessment List
Time frame: Baseline to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 28262404Naro 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.
- Results publication: PubMed 31556512Ferrari 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.
- Results publicationDowns (2015) reviewed the Berg Balance Scale, emphasizing its importance in physiotherapy practice.
- Results publicationDivita (2024) investigated the effects of high- versus low-frequency whole body vibration on TUG, BBS, and walking performance in chronic stroke patients.
- Results publicationChristensen et al. (2019) compared TUG performance in pregnant women with pelvic girdle pain to asymptomatic pregnant and non-pregnant women.
- Results publicationCho et al. (2019) developed a dual-mode feedback-controlled cycling system designed for upper limb rehabilitation in children with cerebral palsy.
- Results publication: PubMed 32065339Bartels 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.
- Results publication: PubMed 30935240Armstrong 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.
- Results publication: PubMed 33146438Armstrong 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.
- Results publicationAnwar, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEDAL Program with Electrical Muscle Stimulation and PEDAL Program without Electrical Muscle Stimulation in people with Cerebral Palsy (CP), run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07173647, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.