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NCT05865418 | Recruiting | Cerebral Palsy


A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

Harshvardhan Singh

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.

Condition or disease

Cerebral Palsy

Muscle Disorder

Physical Disability

Posture Disorders in Children

Intervention/treatment

Loaded high intensity training

High intensity circuit training (HICT)

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 36 participants
Masking: Single
Masking Description: Outcomes assessor will be blinded to the group assignment.
Primary Purpose: Other
Official Title: Feasibility and Response of a Novel Training on Dynamic Balance and Physical Activity in Adolescents With Cerebral Palsy
Actual Study Start Date : August 10, 2023
Estimated Primary Completion Date : May 31, 2026
Estimated Study Completion Date : August 31, 2026
Arm Intervention/treatment

Experimental: Loaded high intensity circuit 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. 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.

Active Comparator: 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.

No Intervention: Control

They will continue their standard-of-care plan and will not involve in any new structured exercise program for 6 weeks.

Ages Eligible for Study: 11 Years to 17 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • have a confirmed diagnosis of spastic cerebral palsy
  • 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.

A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy

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A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy

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Locations


Recruiting

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

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