Improving Activity in Individuals with Cerebral Palsy

Not Applicable

Not yet recruiting

• Conditions: Cerebral Palsy

• Registration Number: NCT06852664
• Lead Sponsor: Father Flanagan's Boys' Home

Brief Summary

Individuals with cerebral palsy are known to have a reduced amount of physical activity; yet, there are no known intervention strategies for improving the number of steps they take each day. This study will use wearable physical activity monitors to assess if behavioral coaching is a viable strategy for combating the reduced physical activity seen in this patient population.

Detailed Description

A lack of physical activity in persons with cerebral palsy is known to have cascading effects on their overall health. Despite this recognition, there have been limited attempts to improve the physical activity of this patient population. The overall landscape of this project is that a cohort of persons with cerebral palsy will undergo 8 weeks of physical activity that is guided by behavioral coaching. This study aims to determine the impact of behavioral coaching on 1) the amount of daily physical activity, 2) changes in the sensorimotor cortical activity, 3) changes in laboratory assessments of functional mobility. The participants with CP will initially undergo neuroimaging and a battery of clinical assessments. After completing the baseline tests, the participants will undergo 8-weeks of behavioral coaching where they are encouraged to increase the number of steps they take per-day. After completing the 8 weeks, the participants will repeat the same assessments that were performed at baseline.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Study Start: 2025-03-01
• Primary Completion: 2029-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Cerebral palsy diagnosis and ambulatory (Gross Motor Function Classification Score [GMFCS] levels between I-III).

Exclusion Criteria

• No orthopedic surgery in the last 6 months, botulinum injections within the last 6 months, or metal in their body that would preclude the use of MEG.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Mobility Test Time	Baseline and 8 weeks	The participant will be asked to perform a series of 10-meter walking tasks such as walking at preferred speed, walking as fast as possible, walking while turning the head, walking around cones, and stepping over a box. The participant will also be asked to walk as far as possible for 1 minute. Completion time will be the primary outcome for these tests. Additionally, the tests will also be digitally video-recorded and scored by an independent assessor.
Change in Time for Timed Up and Go	Baseline and 8 weeks	The participant will start the test by sitting on a bench. The time it takes the participant to stand-up, walk to a line on the floor that is 3-meters away and return to sitting on the bench will be the outcome measure.
Change in Time in 5 Times Sit-to-Stand	Baseline and 8 weeks	The participant will start the test by sitting on a bench. The time it takes to stand up and sit down five times will be the outcome measure.
Changes in Brain Activity	Baseline and 8 weeks	Magnetoencephalography (MEG) will be used to assess the changes in the cortical activity while producing a leg motor action and processing peripheral sensations.

Trial Locations

Locations (1)

Boys Town National Research Hospital; 🇺🇸 Boys Town, Nebraska, United States