Cerebral Palsy, Muscle Disorder, Physical Disability, Posture Disorders in Children, Spina Bifida
Conditions
Brief 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.
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.
Interventions
OTHERLoaded high intensity training
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.
Sponsors
University of Alabama at Birmingham
National Pediatric Rehabilitation Resource Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Adolescents with cerebral palsy will be randomly assigned to two unique exercise regimen and no exercise/standard-of-care group.
Eligibility
Sex/Gender
ALL
Age
11 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unrestrained Walking Speed | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Four Square Step Test | Week 4 | Measure by time to complete test. A decrease in time completed is expected. |
| Timed Up and Go | Week 4 | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHarshvardhan Singh
University of Alabama at Birmingham
Participant flow
Recruitment details
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.
Pre-assignment details
A single non-blinded tester used a simple randomization technique via a computer-generated coding to randomly allocate the enrolled participants to different arms in our study before their baseline testing.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Four square step test | 12.272 second STANDARD_DEVIATION 10.00473738 |
| Race and Ethnicity Not Collected | 0 Participants |
| Restrained maximum walking speed | 70.6382 cm/s STANDARD_DEVIATION 21.02509641 |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 4 Participants |
| Timed Up and Go | 9.17 Seconds STANDARD_DEVIATION 1.032375901 |
| Unrestrained maximum walking speed | 125.3155 cm/s STANDARD_DEVIATION 6.665895626 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 | 0 / 2 |
Outcome results
None listed