Clinical trial NCT05865418: A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy
Official title: Feasibility and Response of a Novel Training on Dynamic Balance and Physical Activity in Adolescents With Cerebral Palsy and Spina Bifida.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Muscle Disorder
Physical Disability
Posture Disorders in Children
Spina Bifida
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 5
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adolescents with cerebral palsy will be randomly assigned to two unique exercise regimen and no exercise/standard-of-care group.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical Activity
timeFrame: Week 1
measure: Physical Activity
timeFrame: Week 6
Secondary outcomes:
measure: Muscle Stiffness
timeFrame: Week 1
measure: Muscle Stiffness
timeFrame: Week 6
measure: Four square step test
timeFrame: Week 1
measure: Four square step test
timeFrame: Week 6
measure: Jumping test
timeFrame: Week 1
measure: Jumping test
timeFrame: Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Harshvardhan Singh
role: PRINCIPAL_INVESTIGATOR
References: