Cerebral PalsyFOLICNCT05865418
A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy
A study testing Loaded high intensity training and High intensity circuit training (HICT) in people with Cerebral Palsy and Muscle Disorder, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this research study is to test the feasibility and response of a new exercise protocol on improving physical activity in adolescents with cerebral palsy. Read more about this study
- Who is it for?
- Ages 11 to 21 years
- Conditions the study is for
- Cerebral Palsy, Muscle Disorder, Physical Disability
- What is being tested?
- Loaded high intensity training and High intensity circuit training (HICT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2023to 20 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- have a confirmed diagnosis of spastic cerebral palsy or spina bifida
- independent ambulatory
- able to follow verbal instructions
- willing to commit to participate for the full study
Who cannot join
- had previous orthopedic surgery or botulinum toxin A injection in the lower limb within past 6 months
- had a structured lower limb exercise training within the past 6 months
- plan to go for any structured outside-of the-study exercise training
- had any heart, lung, vision, hearing or bodily issues that can interfere with participation and completion of the study
- had any other diseases that interfere with physical activity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Feasibility and Response of a Novel Training on Dynamic Balance and Physical Activity in Adolescents With Cerebral Palsy and Spina Bifida.
The purpose of this research study is to test the feasibility and response of a new exercise protocol on improving physical activity in adolescents with cerebral palsy.
Read the detailed description
Only 25% of independent ambulatory children with spastic cerebral palsy (CP) meet the recommendations of time spent in physical activity (PA). Lack of PA during growing years is one of the root causes of obesity, diabetes, and hypertension. Children with CP are known to have poorer dynamic balance and weaker muscle strength than typically developing children, explaining their slower walking speeds, lower PA, and higher tripping and falling than typically developing children. These deficits markedly amplify in adolescence. Consequently, there is a critical need to mitigate deficits in muscle strength and dynamic balance in ambulatory adolescents with CP to increase PA. High intensity circuit training (HICT) vs progressive resistance training (PRT) improved PA to a greater degree in children with CP. Despite the use of HICT, PA in children with CP is still below the recommended level. Our new exercise protocol combines the principles of HICT and PRT in one training program to improve PA in adolescences with CP. The aim of this study is to test the feasibility and response of a new exercise protocol on improving physical activity in adolescents with cerebral palsy. In order to test the feasibility and response of the new exercise protocol, this study will have 3 groups of participants: 1) functionally loaded high intensity training exercise group, 2) a high intensity circuit training group, and 3) control group. For those two exercise groups, this study will include 4-week (weeks 2 - 5) exercise training program (including chair squat, side-step, split squat, heel raise, and jump). Children may/may not wear a weighted vest during exercising depend on their assigned group. For the non-exercise/control group, there is no intervention. Each group will have 2 sessions of baseline testing in week 1 and 1 session of post-testing in week 6. Coming for a single session of testing in week 9 is optional.
The following tests will be assessed before and after the exercise training program for all the groups: Lower limb strength and power via jump tests, balance via four-square step test, lateral step-up test, timed up and go tests, and walking tests. Their muscle and tendon stiffness will be assessed via a handheld device. Free living PA will be assessed via waist-worn accelerometers and questionnaires. Testing will be performed at 5 time points: tests at the first week (baseline 1 and baseline 2), sixth week (post training), ninth week (the follow up) of the study.
- Conditions
- Cerebral Palsy, Muscle Disorder, Physical Disability, Posture Disorders in Children, Spina Bifida
- Being tested
- Loaded high intensity training, High intensity circuit training (HICT)
- Medical subject headings
- Cerebral Palsy, Muscular Diseases, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loaded high intensity trainingOther
Participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. From the week 3rd of the intervention, the participants will perform the exercises with an adjustable weight vest with 5% of their body weight. In the middle intervention (post week 6 of the intervention which will be week 9 of the study), adolescents will be reevaluated for all the measures tested at the baseline. Weight vest will increase to 10% of their body weight for the last 4 weeks of the intervention.
High intensity circuit training (HICT)Other
Participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Loaded high intensity circuit training | Experimental | These participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. From the week 2-5 of the intervention, the participants will perform the exercises with an adjustable weight vest starting with 2.5% to finally reaching 10% of their body weight. Receives: Other: Loaded high intensity training |
| High Intensity Training | Active comparator | These participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. Receives: Other: High intensity circuit training (HICT) |
| Control | No intervention | They will continue their standard-of-care plan and will not involve in any new structured exercise program for 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unrestrained Walking Speed
Unrestrained Maximum Walking Speed Test employed a 6-m-long pressure-sensitive mat (ProtoKinetics Zeno™ Walkway Gait Analysis System; ProtoKinetics LLC, Havertown, PA, USA), where participants started two steps before and walked past the mat at their fastest safe speed, with the mat capturing spatiotemporal gait measures (such as speed (m/s), step length (cm), and cadence (steps/min)) to measure their functional mobility.
Measured: week 4
Restrained Maximum Walking Speed
This test required participants to start by standing on the mat and then walking at their fastest safe speed and stopping at a marked position on the mat near its endpoint
Measured: Week 4
Secondary outcomes (2)
Four Square Step Test
Measure by time to complete test. A decrease in time completed is expected.
Measured: Week 4
Timed Up and Go
The Timed Up and Go Test (TUG) involved participants rising from a standard chair, walking 3 m to a marked cone, turning 180 degrees, and returning to sit, with time recorded in seconds using a stopwatch to evaluate functional mobility
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start10 Aug 2023
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Adolescents with cerebral palsy will be randomly assigned to two unique exercise regimen and no exercise/standard-of-care group.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Pediatric Rehabilitation Resource Center
- Responsible party
- Principal investigator, Harshvardhan Singh, PhD, University of Alabama at Birmingham
- Investigators
- Harshvardhan Singh, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865418
- Sponsor's protocol ID
- IRB-300011118
- Other IDs
- C-PROGRESS, SHP RESEARCH AWARD
- Acronym
- FOLIC
- Status last verified
- Jun 2026
- First submitted
- 1 May 2023
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quach PTM, Fisher G, Lai B, Modlesky CM, Hurt CP, Bowersock CD, Boolani A, Singh H. Feasibility and Preliminary Response of a Novel Training Program on Mobility Parameters in Adolescents with Movement Disorders. Healthcare (Basel). 2025 Dec 11;13(24):3251. doi: 10.3390/healthcare13243251.
PubMed 41464320
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Response of a Novel Training on Dynamic Balance and Physical Activity in Adolescents With Cerebral Palsy and Spina Bifida.
- ClinicalTrials.gov ID
- NCT05865418
- Acronym / sponsor ID
- FOLIC / IRB-300011118
- Conditions
- Cerebral Palsy, Muscle Disorder, Physical Disability, Posture Disorders in Children, Spina Bifida
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Pediatric Rehabilitation Resource Center
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Posted 17 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the feasibility and response of a new exercise protocol on improving physical activity in adolescents with cerebral palsy.
Detailed description
Only 25% of independent ambulatory children with spastic cerebral palsy (CP) meet the recommendations of time spent in physical activity (PA). Lack of PA during growing years is one of the root causes of obesity, diabetes, and hypertension. Children with CP are known to have poorer dynamic balance and weaker muscle strength than typically developing children, explaining their slower walking speeds, lower PA, and higher tripping and falling than typically developing children. These deficits markedly amplify in adolescence. Consequently, there is a critical need to mitigate deficits in muscle strength and dynamic balance in ambulatory adolescents with CP to increase PA. High intensity circuit training (HICT) vs progressive resistance training (PRT) improved PA to a greater degree in children with CP. Despite the use of HICT, PA in children with CP is still below the recommended level. Our new exercise protocol combines the principles of HICT and PRT in one training program to improve PA in adolescences with CP. The aim of this study is to test the feasibility and response of a new exercise protocol on improving physical activity in adolescents with cerebral palsy. In order to test the feasibility and response of the new exercise protocol, this study will have 3 groups of participants: 1) functionally loaded high intensity training exercise group, 2) a high intensity circuit training group, and 3) control group. For those two exercise groups, this study will include 4-week (weeks 2 - 5) exercise training program (including chair squat, side-step, split squat, heel raise, and jump). Children may/may not wear a weighted vest during exercising depend on their assigned group. For the non-exercise/control group, there is no intervention. Each group will have 2 sessions of baseline testing in week 1 and 1 session of post-testing in week 6. Coming for a single session of testing in week 9 is optional.
The following tests will be assessed before and after the exercise training program for all the groups: Lower limb strength and power via jump tests, balance via four-square step test, lateral step-up test, timed up and go tests, and walking tests. Their muscle and tendon stiffness will be assessed via a handheld device. Free living PA will be assessed via waist-worn accelerometers and questionnaires. Testing will be performed at 5 time points: tests at the first week (baseline 1 and baseline 2), sixth week (post training), ninth week (the follow up) of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Adolescents with cerebral palsy will be randomly assigned to two unique exercise regimen and no exercise/standard-of-care group.
| Arm | Type | Receives |
|---|---|---|
| Loaded high intensity circuit training | Experimental | Other: Loaded high intensity trainingThese participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. From the week 2-5 of the intervention, the participants will perform the exercises with an adjustable weight vest starting with 2.5% to finally reaching 10% of their body weight. |
| High Intensity Training | Active comparator | Other: High intensity circuit training (HICT)These participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. |
| Control | No intervention | –They will continue their standard-of-care plan and will not involve in any new structured exercise program for 6 weeks. |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- have a confirmed diagnosis of spastic cerebral palsy or spina bifida
- independent ambulatory
- able to follow verbal instructions
- willing to commit to participate for the full study
Key exclusion criteria (5 listed)
- had previous orthopedic surgery or botulinum toxin A injection in the lower limb within past 6 months
- had a structured lower limb exercise training within the past 6 months
- plan to go for any structured outside-of the-study exercise training
- had any heart, lung, vision, hearing or bodily issues that can interfere with participation and completion of the study
- had any other diseases that interfere with physical activity.
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 |
|---|---|---|
| Loaded high intensity trainingParticipants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. From the week 3rd of the intervention, the participants will perform the exercises with an adjustable weight vest with 5% of their body weight. In the middle intervention (post week 6 of the intervention which will be week 9 of the study), adolescents will be reevaluated for all the measures tested at the baseline. Weight vest will increase to 10% of their body weight for the last 4 weeks of the intervention. | Other | Loaded high intensity circuit training |
| High intensity circuit training (HICT)Participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. | Other | High Intensity Training |
Primary outcome
Unrestrained Walking Speed
Time frame: week 4
Unrestrained Maximum Walking Speed Test employed a 6-m-long pressure-sensitive mat (ProtoKinetics Zeno™ Walkway Gait Analysis System; ProtoKinetics LLC, Havertown, PA, USA), where participants started two steps before and walked past the mat at their fastest safe speed, with the mat capturing spatiotemporal gait measures (such as speed (m/s), step length (cm), and cadence (steps/min)) to measure their functional mobility.
Restrained Maximum Walking Speed
Time frame: Week 4
This test required participants to start by standing on the mat and then walking at their fastest safe speed and stopping at a marked position on the mat near its endpoint
2 secondary outcomes
Four Square Step Test
Time frame: Week 4
Timed Up and Go
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41464320Quach PTM, Fisher G, Lai B, Modlesky CM, Hurt CP, Bowersock CD, Boolani A, Singh H. Feasibility and Preliminary Response of a Novel Training Program on Mobility Parameters in Adolescents with Movement Disorders. Healthcare (Basel). 2025 Dec 11;13(24):3251. doi: 10.3390/healthcare13243251.
- 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.
Harshvardhan Singh principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loaded high intensity training and High intensity circuit training (HICT) in people with Cerebral Palsy and Muscle Disorder, run by University of Alabama at Birmingham at 1 site in United States.
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: finished, as of the sponsor's last update on 17 Aug 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Unrestrained Walking Speed (time frame: week 4). 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 NCT05865418, 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 17 Aug 2026.