Improving Activity in Individuals With Cerebral Palsy
ConditionCerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-45
SponsorFather Flanagan's Boys' Home
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cerebral palsy diagnosis and ambulatory (Gross Motor Function Classification Score [GMFCS] levels between I-III).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Motivational Interviewing
BehavioralThe 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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Cerebral Palsy Youth/Young AdultsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 8 weeks2
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.
Time frame
Baseline and 8 weeks3
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.
Time frame
Baseline and 8 weeks4
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.
Time frame
Baseline and 8 weeksSponsors and contacts
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Source ClinicalTrials.gov