Improving Activity in Individuals With Cerebral Palsy

NCT ID: NCT06852664

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2029-03-01

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cerebral Palsy participants will undergo baseline mobility/brain imaging/cognitive testing, receive motivational interviewing, and then repeat mobility/brain imaging testing.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cerebral Palsy Youth/Young Adults

Baseline and 8-week assessments as well as 8 weeks of motivational interviewing 3x/week

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Coaching

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Father Flanagan's Boys' Home

OTHER

Sponsor Role lead

Responsible Party

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Max Kurz

Director of PoWER Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boys Town National Research Hospital

Boys Town, Nebraska, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Max J Kurz, PhD

Role: CONTACT

531-355-8924

Jennifer M Kime, MS

Role: CONTACT

531-355-8959

Facility Contacts

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Max J Kurz, PhD

Role: primary

402-559-6415

Other Identifiers

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24-23-XP

Identifier Type: -

Identifier Source: org_study_id

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