An interventional study of Loaded high intensity training and High intensity circuit training (HICT) in Cerebral Palsy, Muscle Disorder and Physical Disability, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 11 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other
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.
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's enrollment of 5 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
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Exclusion Criteria:
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.
Other: Loaded high intensity training
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.
Other: High intensity circuit training (HICT)
They will continue their standard-of-care plan and will not involve in any new structured exercise program for 6 weeks.
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.
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.
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.
Time frame: 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
Time frame: Week 4
Four Square Step Test
Measure by time to complete test. A decrease in time completed is expected.
Time frame: 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
Time frame: Week 4
Participants were recruited through convenience sampling. Recruitment involved advertisements placed on clinical trial websites, flyers posted around the University of Alabama at Birmingham (UAB) campus buildings, referrals from healthcare providers, and word-of-mouth recommendations. Interested individuals reached out to research staff via email or phone and were screened for eligibility through telephone interviews.
| Milestone | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control |
|---|---|---|---|
| Started | 2 | 1 | 2 |
| Completed | 2 | 1 | 2 |
| Not completed | 0 | 0 | 0 |
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.
| cm/s | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control |
|---|---|---|---|
| Unrestrained Walking Speed | 138.026 ± 3.54119076 | 72.957 ± 0 | 225.341 ± 20.3024499 |
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
| cm/s | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control |
|---|---|---|---|
| Restrained Maximum Walking Speed | 70.537 ± 6.580335706 | 47.121 ± 0 | 92.6655 ± 13.00581503 |
Measure by time to complete test. A decrease in time completed is expected.
| seconds | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control |
|---|---|---|---|
| Four Square Step Test | 7.64 ± 0.353553391 | 20.73 ± 0 | 5.95 ± 0.395979797 |
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
| seconds | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control |
|---|---|---|---|
| Timed Up and Go | 9.225 ± 0.883883476 | 12.96 ± 0 | 8.585 ± 0.473761543 |
Collected over from enrollment until end of 4 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Functionally Loaded High-Intensity Circuit Training (FUNHIT) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| High-Intensity Circuit Training (HIT) | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Control | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
This study focused on feasibility rather than efficacy. A total of five participants (one CP and four SB), ages ranging from \~14 to \~20 years, were included in the study.
| Age, Categorical(Participants) | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control | Total |
|---|---|---|---|---|
| <=18 years | 1 | 1 | 2 | 4 |
| Between 18 and 65 years | 1 | 0 | 0 | 1 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control | Total |
|---|---|---|---|---|
| Female | 1 | 0 | 0 | 1 |
| Male | 1 | 1 | 2 | 4 |
| Race and Ethnicity Not Collected(Participants) | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Unrestrained maximum walking speed(cm/s) | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control | Total |
|---|---|---|---|---|
| Mean | 125.3155 ± 6.665895626 | 71.397 ± 0 | 213.6925 ± 5.400174488 | 149.8826 ± 62.41810021 |
| Restrained maximum walking speed(cm/s) | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control | Total |
|---|---|---|---|---|
| Mean | 66.623 ± 12.2626458 | 41.2 ± 0 | 89.3725 ± 4.128796495 | 70.6382 ± 21.02509641 |
| Four square step test(second) | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control | Total |
|---|---|---|---|---|
| Mean | 9.92 ± 1.725340546 | 29.73 ± 0 | 5.895 ± 0.473761543 | 12.272 ± 10.00473738 |
| Timed Up and Go(Seconds) | Functionally Loaded High-Intensity Circuit Training (FUNHIT) | High-Intensity Circuit Training (HIT) | Control | Total |
|---|---|---|---|---|
| Mean | 9.575 ± 0.926309883 | 14.64 ± 0 | 9.17 ± 1.032375901 | 10.426 ± 2.463996753 |
PDFs hosted by the registry, ClinicalTrials.gov.
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