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

NCT05865418 | Completed

• 3 other identifiers: 300011118C-PROGRESSSHP RESEARCH AWARD
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Muscle Disorder; Physical Disability; Posture Disorders in Children; Spina Bifida

Outcome Measures

Primary Outcomes (2)

• Physical Activity

  Step counts.

  Week 1

• Physical Activity

  Step counts. An increase in step counts is expected.

  Week 6

Secondary Outcomes (6)

• Muscle Stiffness

  Week 1

• Muscle Stiffness

  Week 6

• Four square step test

  Week 1

• Four square step test

  Week 6

• Jumping test

  Week 1

Study Arms (3)

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.

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.

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.

Interventions

Loaded high intensity training 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. 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.

Loaded high intensity circuit training

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.

High Intensity Training

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscular Diseases; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Harshvardhan Singh

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Adolescents with cerebral palsy will be randomly assigned to two unique exercise regimen and no exercise/standard-of-care group.

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 18, 2023
• Study Start: August 10, 2023
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)