CPNCT06996028
LIFT & PEDALS on Balance and Mobility in Children With CP
A study testing Strengthening domain, Balance domain, Coordination domain, Gait domain and Lower extremity strengthening, Cardiorespiratory endurance in people with CP, run by Riphah International University at 1 site in Pakistan.
Trial summary
Children with cerebral palsy (CP) have impaired balance due to poor postural control and coordination, increasing fall risk and limiting daily activities. This randomized controlled trial aims to compare the effects of Lower-Extremity Functional Training (LIFT) and Pediatric Endurance and Limb Strengthening (PEDALS)… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- CP
- What is being tested?
- Strengthening domain, Balance domain, Coordination domain, Gait domain and Lower extremity strengthening, Cardiorespiratory endurance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Gross Motor Function Classification System level of I to II
- Ability to follow 2-step instructions and complete testing.
- Age between 6 and 12 years.
- Children with cerebral palsy
Who cannot join
- Cognitive delay preventing 2-step instructions
- Visual problem preventing performance of interventions.
- Caregivers unable to commit to duration of intervention.
- If patient had unstable seizures.
- If any change in medication was expected during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Muhammad Asif Javed
Lahore, Punjab Province, 54900
imran Javed, PHD, 9233224390125, imran.amjad@riphah.edu.pk
Muhammad Asif javed, MS-PT, 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Comparative Effects of (LIFT) Lower-extremity Functional Training and (PEDALS) Pediatric Endurance and Limb Strengthening on Balance and Mobility in Children With Cerebral Palsy
Children with cerebral palsy (CP) have impaired balance due to poor postural control and coordination, increasing fall risk and limiting daily activities. This randomized controlled trial aims to compare the effects of Lower-Extremity Functional Training (LIFT) and Pediatric Endurance and Limb Strengthening (PEDALS) on balance and mobility in children with diplegic CP. A total of 22 children (ages 6-12) from Adil Special School, Sargodha, will be randomly assigned to two groups. One group will perform exercises targeting strength, coordination, gait, and balance; the other will perform pedaling exercises. Pre- and post-intervention assessments will include the 6-Minute Walk Test, GMFM-88, and Pediatric Balance Scale. Data will be analyzed using SPSS 23
Read the detailed description
Balance in children with CP is impaired by poor postural control mechanism. Earlier studies on balance have found that children with CP had poor static and dynamic balance reactions than those of typically developing children . These balance problems increase risk of falls, which further affected children with cerebral palsy in performance of activities of daily living mobility and participation. Cerebral palsy also causes coordination problems. Brain can not properly send messages to muscles about how to move in smooth and well coordinated ways. The aim of the study is to analyse comparative effects of (LIFT) lower-extremity functional training and (PEDALS) pediatric endurance and limb strenghtening on balance and mobility in children with cerebral palsy The current study will be randomized control trial; data will be collected from Sargodha Adil Special School and Rehabilitation Centre.The study will include 22 patients equally divided in two groups and randomly allocated. Inclusion criteria for the study will be ability to walk independently, ability to follow 2-step instructions and complete testing. Age between 6 and 12 years. Ability to participate in group training program and children with diplegic cerebral palsy. Patients with cognitive delay,visual problems. Seizures, or if there is change in medication will be expected during the study or if patient is suffering from disease that interfered with physical activity will be excluded from the study. One experimental group will perform 4 domains of exercises (strengthening, coordination, gait and balance). In second experimental group pedalling exercise will be performed. Data collection will be done before and after intervention. Tools used for data collection will be 6 minute walk test, GMFM88, Pediatric balance scale. Data will be analysed through SPSS version 23.00.
- Conditions
- CP
- Being tested
- Strengthening domain, Balance domain, Coordination domain, Gait domain, Lower extremity strengthening, Cardiorespiratory endurance
- Keywords
- CP, LIFT, 6 min walk test, GMF88
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening domain, Balance domain, Coordination domain, Gait domainOther
The experimental group will engage in a structured exercise program targeting strength, balance, gait, and coordination. Strength exercises include sit-to-stand, step-ups, vertical jumping, and stair climbing. Balance training involves tandem walking, one-leg standing, and balancing on unstable surfaces. Gait exercises include bridging, clamshells, and heel rises, while coordination activities involve ball kicking, hopping through squares, and galloping/skipping. The program runs for 2 hours per day, 5 days a week, over 6 weeks, with sessions optionally split into shorter segments.
Lower extremity strengthening, Cardiorespiratory enduranceOther
Group B will follow the PEDALS program, involving stationary cycling three times a week for 30 minutes per session. Each session includes lower-limb strengthening with gradual resistance progression and cardiorespiratory endurance training aimed at increasing cycling duration to 15-30 minutes. Proper bike setup and participant support are ensured, and each session ends with a cool-down period of pedaling without resistance until heart rate returns near baseline.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The experimental group will follow the LIFT (Lifestyle Intervention for Function and Training) program, which includes exercises across four domains: strengthening (sit-to-stand, step-ups, vertical jumping, stair climbing), balance (tandem walking, one-leg standing, balancing on unstable surfaces), gait (bridging, clamshells, heel rises), and coordination (ball kicking, hopping through squares, galloping/skipping). The training will be conducted for 2 hours per day, 5 days a week, over 6 weeks . Each 2-hour session can be divided into two 1-hour sessions or four 30-minute sessions. Receives: Other: Strengthening domain, Balance domain, Coordination domain, Gait domain; Other: Lower extremity strengthening, Cardiorespiratory endurance |
| Group B | Experimental | Experimental Group (Group B): The PEDALS program involves stationary cycling three times a week for 30 minutes per session, divided into two phases. Phase 1 focuses on lower-limb strengthening, where participants are properly positioned on the bike and encouraged to pedal with increasing resistance as tolerated. Phase 2 targets cardiorespiratory endurance, aiming to gradually increase cycling duration to 15-30 minutes, followed by a cool-down with low-intensity pedaling until heart rate returns close to baseline. Receives: Other: Strengthening domain, Balance domain, Coordination domain, Gait domain; Other: Lower extremity strengthening, Cardiorespiratory endurance |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 MINUTE WALK TEST FOR ENDURANCE
The Six-Minute Walk Test (6MWT), introduced by the American Thoracic Society in 2002, is a submaximal test used to assess aerobic capacity and endurance by measuring the distance walked in six minutes.
Measured: Baseline, 4th week, 6th week
PEDIATRIC BALANCE SCALE(BBS)
The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale,
to assess balance in school-age children with mild to moderate motor impairments.
The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale, designed to assess balance in school-age children with mild to moderate motor impairments. It has demonstrated strong reliability and validity, with an intraobserver ICC of 0.927, a Cronbach's alpha of 0.857, and a concurrent validity of r = 0.692 (p < 0.0005).
The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale, designed to assess balance in school-age children with mild to moderate motor impairments. It has demonstrated strong reliability and validity, with an intraobserver ICC of 0.927, a Cronbach's alpha of 0.857, and a concurrent validity of r = 0.692 (p < 0.0005).
Measured: Baseline, 4th week, 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start15 May 2025
- Primary completion29 Jun 2025 (estimated)
- Study completion15 Jul 2025 (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 CPStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized clinical trial performed,in which 20 CP children with the age of 6-12 years will be taken randomly after screening and meeting inclusion criteria. Children will be divided in two groups. Group 1 will receive LIFT for 2 hours 5 days a week. Group 2 will receive PEDALS for 2 hours 5 days a week. Pre values were taken at 1st week and then after 4th week mid values of interventions will be taken and post values of intervention will be taken after 6 weeks of intervention to measure the effects of both therapies.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aniqa Feroz, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996028
- Sponsor's protocol ID
- REC/RCR/AHS/25/aniqa feroz
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biyik KS, Gunel MK, Akyuz EU. How does treadmill training contribute to botulinum toxin application plus routine physical therapy in ambulatory children with spastic bilateral cerebral palsy? A randomized controlled trial. Ir J Med Sci. 2023 Feb;192(1):209-217. doi: 10.1007/s11845-022-02960-9. Epub 2022 Feb 27.
PubMed 35224682
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of (LIFT) Lower-extremity Functional Training and (PEDALS) Pediatric Endurance and Limb Strengthening on Balance and Mobility in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06996028
- Acronym / sponsor ID
- REC/RCR/AHS/25/aniqa feroz
- Conditions
- CP
- Keywords
- CP, LIFT, 6 min walk test, GMF88
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 29 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 30 May 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.
Children with cerebral palsy (CP) have impaired balance due to poor postural control and coordination, increasing fall risk and limiting daily activities. This randomized controlled trial aims to compare the effects of Lower-Extremity Functional Training (LIFT) and Pediatric Endurance and Limb Strengthening (PEDALS) on balance and mobility in children with diplegic CP. A total of 22 children (ages 6-12) from Adil Special School, Sargodha, will be randomly assigned to two groups. One group will perform exercises targeting strength, coordination, gait, and balance; the other will perform pedaling exercises. Pre- and post-intervention assessments will include the 6-Minute Walk Test, GMFM-88, and Pediatric Balance Scale. Data will be analyzed using SPSS 23
Detailed description
Balance in children with CP is impaired by poor postural control mechanism. Earlier studies on balance have found that children with CP had poor static and dynamic balance reactions than those of typically developing children . These balance problems increase risk of falls, which further affected children with cerebral palsy in performance of activities of daily living mobility and participation. Cerebral palsy also causes coordination problems. Brain can not properly send messages to muscles about how to move in smooth and well coordinated ways. The aim of the study is to analyse comparative effects of (LIFT) lower-extremity functional training and (PEDALS) pediatric endurance and limb strenghtening on balance and mobility in children with cerebral palsy The current study will be randomized control trial; data will be collected from Sargodha Adil Special School and Rehabilitation Centre.The study will include 22 patients equally divided in two groups and randomly allocated. Inclusion criteria for the study will be ability to walk independently, ability to follow 2-step instructions and complete testing. Age between 6 and 12 years. Ability to participate in group training program and children with diplegic cerebral palsy. Patients with cognitive delay,visual problems. Seizures, or if there is change in medication will be expected during the study or if patient is suffering from disease that interfered with physical activity will be excluded from the study. One experimental group will perform 4 domains of exercises (strengthening, coordination, gait and balance). In second experimental group pedalling exercise will be performed. Data collection will be done before and after intervention. Tools used for data collection will be 6 minute walk test, GMFM88, Pediatric balance scale. Data will be analysed through SPSS version 23.00.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A Randomized clinical trial performed,in which 20 CP children with the age of 6-12 years will be taken randomly after screening and meeting inclusion criteria. Children will be divided in two groups. Group 1 will receive LIFT for 2 hours 5 days a week. Group 2 will receive PEDALS for 2 hours 5 days a week. Pre values were taken at 1st week and then after 4th week mid values of interventions will be taken and post values of intervention will be taken after 6 weeks of intervention to measure the effects of both therapies.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Strengthening domain, Balance domain, Coordination domain, Gait domain, Other: Lower extremity strengthening, Cardiorespiratory enduranceThe experimental group will follow the LIFT (Lifestyle Intervention for Function and Training) program, which includes exercises across four domains: strengthening (sit-to-stand, step-ups, vertical jumping, stair climbing), balance (tandem walking, one-leg standing, balancing on unstable surfaces), gait (bridging, clamshells, heel rises), and coordination (ball kicking, hopping through squares, galloping/skipping). The training will be conducted for 2 hours per day, 5 days a week, over 6 weeks . Each 2-hour session can be divided into two 1-hour sessions or four 30-minute sessions. |
| Group B | Experimental | Other: Strengthening domain, Balance domain, Coordination domain, Gait domain, Other: Lower extremity strengthening, Cardiorespiratory enduranceExperimental Group (Group B): The PEDALS program involves stationary cycling three times a week for 30 minutes per session, divided into two phases. Phase 1 focuses on lower-limb strengthening, where participants are properly positioned on the bike and encouraged to pedal with increasing resistance as tolerated. Phase 2 targets cardiorespiratory endurance, aiming to gradually increase cycling duration to 15-30 minutes, followed by a cool-down with low-intensity pedaling until heart rate returns close to baseline. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gross Motor Function Classification System level of I to II
- Ability to follow 2-step instructions and complete testing.
- Age between 6 and 12 years.
- Children with cerebral palsy
Key exclusion criteria (5 listed)
- Cognitive delay preventing 2-step instructions
- Visual problem preventing performance of interventions.
- Caregivers unable to commit to duration of intervention.
- If patient had unstable seizures.
- If any change in medication was expected during the study.
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 |
|---|---|---|
| Strengthening domain, Balance domain, Coordination domain, Gait domainThe experimental group will engage in a structured exercise program targeting strength, balance, gait, and coordination. Strength exercises include sit-to-stand, step-ups, vertical jumping, and stair climbing. Balance training involves tandem walking, one-leg standing, and balancing on unstable surfaces. Gait exercises include bridging, clamshells, and heel rises, while coordination activities involve ball kicking, hopping through squares, and galloping/skipping. The program runs for 2 hours per day, 5 days a week, over 6 weeks, with sessions optionally split into shorter segments. | Other | Group A, Group B |
| Lower extremity strengthening, Cardiorespiratory enduranceGroup B will follow the PEDALS program, involving stationary cycling three times a week for 30 minutes per session. Each session includes lower-limb strengthening with gradual resistance progression and cardiorespiratory endurance training aimed at increasing cycling duration to 15-30 minutes. Proper bike setup and participant support are ensured, and each session ends with a cool-down period of pedaling without resistance until heart rate returns near baseline. | Other | Group A, Group B |
Primary outcome
6 MINUTE WALK TEST FOR ENDURANCE
Time frame: Baseline, 4th week, 6th week
The Six-Minute Walk Test (6MWT), introduced by the American Thoracic Society in 2002, is a submaximal test used to assess aerobic capacity and endurance by measuring the distance walked in six minutes.
PEDIATRIC BALANCE SCALE(BBS)
Time frame: Baseline, 4th week, 6th week
The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale, to assess balance in school-age children with mild to moderate motor impairments. The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale, designed to assess balance in school-age children with mild to moderate motor impairments. It has demonstrated strong reliability and validity, with an intraobserver ICC of 0.927, a Cronbach's alpha of 0.857, and a concurrent validity of r = 0.692 (p < 0.0005). The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale, designed to assess balance in school-age children with mild to moderate motor impairments. It has demonstrated strong reliability and validity, with an intraobserver ICC of 0.927, a Cronbach's alpha of 0.857, and a concurrent validity of r = 0.692 (p < 0.0005).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Background: PubMed 35224682Biyik KS, Gunel MK, Akyuz EU. How does treadmill training contribute to botulinum toxin application plus routine physical therapy in ambulatory children with spastic bilateral cerebral palsy? A randomized controlled trial. Ir J Med Sci. 2023 Feb;192(1):209-217. doi: 10.1007/s11845-022-02960-9. Epub 2022 Feb 27.
- 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.
Aniqa Feroz, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening domain, Balance domain, Coordination domain, Gait domain and Lower extremity strengthening, Cardiorespiratory endurance in people with CP, run by Riphah International University 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: looking for participants now, as of the sponsor's last update on 30 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, PHD (92332224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 MINUTE WALK TEST FOR ENDURANCE (time frame: Baseline, 4th week, 6th week). The study lists 2 primary outcomes in all. 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 NCT06996028, 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 30 May 2025.