Improving Activity in Individuals With Cerebral Palsy (Fitbit)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Motivational Interviewing

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Max J Kurz, PhD; Phone Number: 531-355-8924; Email: max.kurz@boystown.org
• Study Contact Backup: Name: Jennifer M Kime, MS; Phone Number: 531-355-8959; Email: jennifer.kime@boystown.org

Study Locations

• United States
  • Nebraska
    • Boys Town, Nebraska, United States, 68010
      • Recruiting
      • Boys Town National Research Hospital
      • Contact: Max J Kurz, PhD; Phone Number: 402-559-6415; Email: max.kurz@boystown.org
      • Principal Investigator: Max J Kurz, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cerebral Palsy Youth/Young Adults; Baseline and 8-week assessments as well as 8 weeks of motivational interviewing 3x/week

Behavioral: Motivational Interviewing; The participants will meet with the research staff three times a week during the eight weeks of wearing the activity monitor via video or Webex call with a duration ideally not exceeding one hour. All staff involved in these coaching sessions have been MINT trained and certified and have mastered the skills of motivational interviewing. Their goal will be to discuss with the participant about how successful they have been or not been in increasing their daily step count and movement and discussing the barriers preventing them from achieving that goal. Open-ended questions, affirmations, reflections, summaries, balancing change and sustain talk, and eliciting change behavior will all be used accordingly during the sessions. Coaching is tied to the overall results in investigating if motivational interviewing and coaching are effective in increasing movement in populations with cerebral palsy.; Other Names: Coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mobility Test Time	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.	Baseline and 8 weeks
Change in Time in 5 Times Sit-to-Stand	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.	Baseline and 8 weeks
Change in Time for Timed Up and Go	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.	Baseline and 8 weeks
Changes in Brain Activity	Magnetoencephalography (MEG) will be used to assess the changes in the cortical activity while producing a leg motor action and processing peripheral sensations.	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Father Flanagan's Boys' Home

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Mobility; Fitbit; Steps
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Motivational Interviewing
• Other Study ID Numbers: 24-23-XP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PI and all of the investigators have made a commitment to publish, in a timely manner, all of the relevant scientific information that they will derive during this project. Deidentified data will be made available upon reasonable request to the Principal Investigator (Dr. Kurz).
• IPD Sharing Time Frame: Upon completion of study and data analysis
• IPD Sharing Access Criteria: Contact Dr. Kurz
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No