Skip to content

Improving Activity in Individuals With Cerebral Palsy

Improving Activity in Individuals With Cerebral Palsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06852664
Acronym
Fitbit
Enrollment
32
Registered
2025-02-28
Start date
2025-03-01
Completion date
2029-03-01
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy, Fitbit, Mobility, Steps

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.

Interventions

BEHAVIORALMotivational 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.

Sponsors

Father Flanagan's Boys' Home
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
11 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Mobility Test TimeBaseline and 8 weeksThe 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 in 5 Times Sit-to-StandBaseline and 8 weeksThe 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.
Change in Time for Timed Up and GoBaseline and 8 weeksThe 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.
Changes in Brain ActivityBaseline and 8 weeksMagnetoencephalography (MEG) will be used to assess the changes in the cortical activity while producing a leg motor action and processing peripheral sensations.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026