Cerebral PalsyPEDALSNCT06479395
Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program VS Task-Oriented Training (TOT) Improving Gross Motor Function in Children With Cerebral Palsy
A study testing Pediatric Endurance and Limb Strengthening (PEDALS) program and Task-Oriented Training (TOT) in people with Cerebral Palsy, run by Shalamar Institute of Health Sciences at 1 site in Pakistan.
Trial summary
To compare the Effects of Pediatric endurance and limb strengthening (PEDALS) program VS Task-oriented Training (TOT) improving gross motor function among children with Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Pediatric Endurance and Limb Strengthening (PEDALS) program and Task-Oriented Training (TOT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Jun 2024to 30 Dec 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Diplegic Cerebral Palsy children
- Gross motor classification system level 1and level 2.
- Age 6 to 12 years.
- Male and female are included.
Who cannot join
- • Individuals with co-existing medical conditions that significantly impact motor function other than CP.
- Participants who are unable to engage in the assigned interventions due to physical or cognitive limitations.
- Gross motor classification system level 3.4 and 5.
- Any contraindications to the assigned interventions, such as severe motion sickness or contraindications to physical exercise for pedal training.
- Previous participation in similar interventions within a defined timeframe to avoid potential confounding effects.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rising Sun institute for Special children Mughalpura campus Lahore
Lahore, Punjab Province, 54000
Dr ALI Hammad, 03045517800
DR sadaf tubassam, 03334328866, dr.sadafmiyan@gmail.com
About this study
To compare the Effects of Pediatric endurance and limb strengthening (PEDALS) program VS Task-oriented Training (TOT) improving gross motor function among children with Cerebral Palsy.
Read the detailed description
By integrating the Pediatric endurance and limb strengthening (PEDALS) exercises and Task Oriented training children can engage in more comprehensive therapy that simultaneously targets muscle strengthening, coordination and balance with in a context that stimulates real life activities. Task Oriented Training interventions can promote neural plasticity through repetitive task specific practice. It will have marked impact on improvement of ADLS in CP community. This study will play a vital role in improving the mobility of CP community. Hence improving the gross motor functions i.e. facilitating the CP child being more independent in sitting standing jumping and running.
- Conditions
- Cerebral Palsy
- Being tested
- Pediatric Endurance and Limb Strengthening (PEDALS) program, Task-Oriented Training (TOT)
- Keywords
- Task-Oriented Training (TOT), Pediatric Endurance and Limb Strengthening (PEDALS), gross motor function (GMF)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Endurance and Limb Strengthening (PEDALS) programOther
Participants will perform pediatric endurance and limb strengthening (PEDALS) program. The stationary cycling intervention will be performed 3 times per week, for a total of 24 sessions, within 8 weeks period. The longer session duration is designed to allow adequate rest intervals between set (1-3 minutes). A generalized stretching program will be performed prior to cycling for mental relaxation for 6-7 minutes. Ankle-foot orthosis if used for walking. Each 60 minutes cycling session will be divided into 2 phases: (1) lower-extremity strengthening and (2) cardiorespiratory endurance.
Task-Oriented Training (TOT)Other
The experimental protocol consists of task-oriented training program (TOT) .it will be performed 3 times per week, for a total of 24 sessions, within 8 weeks period. Before each training session, there will be a warm-up period with 5 to 10 minutes of dynamic activities (e.g., jogging). After training, there will be a cool down period with 5 to 10 minutes of dynamic stretching exercises. In addition to rest intervals. after training session, there will be a 48-hour rest interval to prevent muscle fatigue and injury.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Endurance and Limb Strengthening (PEDALS) program | Experimental | Phase 1: lower-extremity strengthening: Resistance will be progressed to the next higher cord when 10 revolutions will be performed in a smooth pattern while keeping the seat within the desired zone.
Phase 2: cardiorespiratory endurance: The goal of this phase is to gradually increase duration and intensity. The seat will be locked in a location that will position the participants knee in 15 to 20 degrees of flexion. The exercise duration goal will be 15 to 30 minutes. A cool down period consists of pedaling without resistance until heart rate (HR) decreases to within 20 bpm.(11) Receives: Other: Pediatric Endurance and Limb Strengthening (PEDALS) program |
| Task-Oriented Training (TOT) | Active comparator | The task-oriented training will focus on lower extremity strengthening comprised of the following: 1) The subjects will maintain a standing position for three seconds 2) The subjects will stand on one leg for three seconds while holding a chair with one hand 3) The subjects will stand up from a chair without using their arms 4) The subjects will stand up from a half kneeling position without using their arms 5) The subjects will kick a ball 6) The subjects has to climb up and climbed down four steps. All treatment procedures will be implemented for 40 minutes, thrice a week, for a total of eight weeks per session. including rest periods. The number of repetitions will be increased every 2 weeks up to a maximum of 15 repetitions if the participants will able to perform the training easily. (4) Receives: Other: Task-Oriented Training (TOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
gross motor function
The improving gross motor functions i.e A) lying and rolling B) sitting C) crawling and kneeling D) standing and E) walking, running, and jumping.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start27 Jun 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalamar Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, amana saeed, Shalamar Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479395
- Sponsor's protocol ID
- ShalamarIHS-722
- Acronym
- PEDALS
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Dimitrijevic L. Management of cerebral palsy through the childhood: How does it work in Serbia? Preventive Paediatrics. 2024:039-44. 2. Bekteshi S, Monbaliu E, McIntyre S, Saloojee G, Hilberink SR, Tatishvili N, et al. Towards functional improvement of motor disorders associated with cerebral palsy. The Lancet Neurology. 202322(3):229-43. 3. Hasan AB, Mohamed NE, El-Sheikh AF. PEDALING EXERCISE AS A REHABILITATION FOR CHILDREN WITH CEREBRAL PALSY (A REVIEW ARTICLE). 4. Ko EJ, Sung IY, Moon HJ, Yuk JS, Kim H-S, Lee NH. Effect of group-task-oriented training on gross and fine motor function, and activities of daily living in children with spastic cerebral palsy. Physical & Occupational Therapy In Pediatrics. 202040(1):18-30. 5. 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. Clinical rehabilitation. 201933(7):1113-29. 6. Dussault-Picard C, Pouliot-Laforte A, Cherriere C, Houle E, Ballaz L. Locomotion Efficiency in Children With Cerebral Palsy Experiencing Limited Gross Motor Function: Walking Versus Cycling. Pediatric Physical Therapy. 202436(2):274-7. 7. Zai W, Xu N, Wu W, Wang Y, Wang R. Effect of task-oriented training on gross motor function, balance and activities of daily living in children with cerebral palsy: A systematic review and meta-analysis. Medicine. 2022101(44):e31565. 8. Madeshwaran S. A Study on the Effectiveness of Task Oriented Strength Training to Enhance Upper Limb Motor Function in Children with Cerebral Palsy. Indian Journal of Physiotherapy & Occupational Therapy. 202418. 9. Ghani HM, Razzaq M, Safdar N, Umer B, Tariq F. Effects of Stationary Cycling on Spasticity and Range of Motion in Children with Diplegic Cerebral Palsy: A Quasi Interventional Study. Foundation University Journal of Rehabilitation Sciences. 20211(1):24-8. 10. Mazumdar C. Effect of task-oriented training on motor function in children with cerebral palsy: a systemic review: Lietuvos sporto universitetas. 2021. 11. Demuth SK, Knutson LM, Fowler EG. The PEDALS stationary cycling intervention and health-related quality of life in children with cerebral palsy: A randomized controlled trial. Developmental Medicine & Child Neurology. 201254(7):654-61.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program VS Task-Oriented Training (TOT) Improving Gross Motor Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06479395
- Acronym / sponsor ID
- PEDALS / ShalamarIHS-722
- Conditions
- Cerebral Palsy
- Keywords
- Task-Oriented Training (TOT), Pediatric Endurance and Limb Strengthening (PEDALS), gross motor function (GMF)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shalamar Institute of Health SciencesUniversity, hospital or other
- Study start
- 27 Jun 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Jun 2024 (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.
To compare the Effects of Pediatric endurance and limb strengthening (PEDALS) program VS Task-oriented Training (TOT) improving gross motor function among children with Cerebral Palsy.
Detailed description
By integrating the Pediatric endurance and limb strengthening (PEDALS) exercises and Task Oriented training children can engage in more comprehensive therapy that simultaneously targets muscle strengthening, coordination and balance with in a context that stimulates real life activities. Task Oriented Training interventions can promote neural plasticity through repetitive task specific practice. It will have marked impact on improvement of ADLS in CP community. This study will play a vital role in improving the mobility of CP community. Hence improving the gross motor functions i.e. facilitating the CP child being more independent in sitting standing jumping and running.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Endurance and Limb Strengthening (PEDALS) program | Experimental | Other: Pediatric Endurance and Limb Strengthening (PEDALS) programPhase 1: lower-extremity strengthening: Resistance will be progressed to the next higher cord when 10 revolutions will be performed in a smooth pattern while keeping the seat within the desired zone. Phase 2: cardiorespiratory endurance: The goal of this phase is to gradually increase duration and intensity. The seat will be locked in a location that will position the participants knee in 15 to 20 degrees of flexion. The exercise duration goal will be 15 to 30 minutes. A cool down period consists of pedaling without resistance until heart rate (HR) decreases to within 20 bpm.(11) |
| Task-Oriented Training (TOT) | Active comparator | Other: Task-Oriented Training (TOT)The task-oriented training will focus on lower extremity strengthening comprised of the following: 1) The subjects will maintain a standing position for three seconds 2) The subjects will stand on one leg for three seconds while holding a chair with one hand 3) The subjects will stand up from a chair without using their arms 4) The subjects will stand up from a half kneeling position without using their arms 5) The subjects will kick a ball 6) The subjects has to climb up and climbed down four steps. All treatment procedures will be implemented for 40 minutes, thrice a week, for a total of eight weeks per session. including rest periods. The number of repetitions will be increased every 2 weeks up to a maximum of 15 repetitions if the participants will able to perform the training easily. (4) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Diplegic Cerebral Palsy children
Key exclusion criteria (5 listed)
- • Individuals with co-existing medical conditions that significantly impact motor function other than CP.
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 |
|---|---|---|
| Pediatric Endurance and Limb Strengthening (PEDALS) programParticipants will perform pediatric endurance and limb strengthening (PEDALS) program. The stationary cycling intervention will be performed 3 times per week, for a total of 24 sessions, within 8 weeks period. The longer session duration is designed to allow adequate rest intervals between set (1-3 minutes). A generalized stretching program will be performed prior to cycling for mental relaxation for 6-7 minutes. Ankle-foot orthosis if used for walking. Each 60 minutes cycling session will be divided into 2 phases: (1) lower-extremity strengthening and (2) cardiorespiratory endurance. | Other | Pediatric Endurance and Limb Strengthening (PEDALS) program |
| Task-Oriented Training (TOT)The experimental protocol consists of task-oriented training program (TOT) .it will be performed 3 times per week, for a total of 24 sessions, within 8 weeks period. Before each training session, there will be a warm-up period with 5 to 10 minutes of dynamic activities (e.g., jogging). After training, there will be a cool down period with 5 to 10 minutes of dynamic stretching exercises. In addition to rest intervals. after training session, there will be a 48-hour rest interval to prevent muscle fatigue and injury. | Other | Task-Oriented Training (TOT) |
Primary outcome
gross motor function
Time frame: 12 weeks
The improving gross motor functions i.e A) lying and rolling B) sitting C) crawling and kneeling D) standing and E) walking, running, and jumping.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background1. Dimitrijevic L. Management of cerebral palsy through the childhood: How does it work in Serbia? Preventive Paediatrics. 2024:039-44. 2. Bekteshi S, Monbaliu E, McIntyre S, Saloojee G, Hilberink SR, Tatishvili N, et al. Towards functional improvement of motor disorders associated with cerebral palsy. The Lancet Neurology. 202322(3):229-43. 3. Hasan AB, Mohamed NE, El-Sheikh AF. PEDALING EXERCISE AS A REHABILITATION FOR CHILDREN WITH CEREBRAL PALSY (A REVIEW ARTICLE). 4. Ko EJ, Sung IY, Moon HJ, Yuk JS, Kim H-S, Lee NH. Effect of group-task-oriented training on gross and fine motor function, and activities of daily living in children with spastic cerebral palsy. Physical & Occupational Therapy In Pediatrics. 202040(1):18-30. 5. 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. Clinical rehabilitation. 201933(7):1113-29. 6. Dussault-Picard C, Pouliot-Laforte A, Cherriere C, Houle E, Ballaz L. Locomotion Efficiency in Children With Cerebral Palsy Experiencing Limited Gross Motor Function: Walking Versus Cycling. Pediatric Physical Therapy. 202436(2):274-7. 7. Zai W, Xu N, Wu W, Wang Y, Wang R. Effect of task-oriented training on gross motor function, balance and activities of daily living in children with cerebral palsy: A systematic review and meta-analysis. Medicine. 2022101(44):e31565. 8. Madeshwaran S. A Study on the Effectiveness of Task Oriented Strength Training to Enhance Upper Limb Motor Function in Children with Cerebral Palsy. Indian Journal of Physiotherapy & Occupational Therapy. 202418. 9. Ghani HM, Razzaq M, Safdar N, Umer B, Tariq F. Effects of Stationary Cycling on Spasticity and Range of Motion in Children with Diplegic Cerebral Palsy: A Quasi Interventional Study. Foundation University Journal of Rehabilitation Sciences. 20211(1):24-8. 10. Mazumdar C. Effect of task-oriented training on motor function in children with cerebral palsy: a systemic review: Lietuvos sporto universitetas. 2021. 11. Demuth SK, Knutson LM, Fowler EG. The PEDALS stationary cycling intervention and health-related quality of life in children with cerebral palsy: A randomized controlled trial. Developmental Medicine & Child Neurology. 201254(7):654-61.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric Endurance and Limb Strengthening (PEDALS) program and Task-Oriented Training (TOT) in people with Cerebral Palsy, run by Shalamar Institute of Health Sciences 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 4 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: status not confirmed, as of the sponsor's last update on 28 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ammana Saeed, DPT (3044304069, dramanasaeed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gross motor function (time frame: 12 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 NCT06479395, which also lists 1 linked publication.
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 Jun 2024.