Motivational Interviewing for Cerebral Palsy

(Fitbit Trial)

Overseen By Jennifer M Kime, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Father Flanagan's Boys' Home

Disqualifiers: Recent surgery, Botulinum injections, Metal implants

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

32 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Motivational Interviewing for Cerebral Palsy?

Motivational Interviewing (MI) has been shown to be effective in helping people change behaviors across various conditions, with a meta-analysis of 72 clinical trials showing positive short-term effects. It is particularly effective in enhancing communication and resolving ambivalence (mixed feelings) about change, which can be beneficial in managing health behaviors. ^{1 2 3 4 5}

Is Motivational Interviewing safe for humans?

There is no specific safety data on Motivational Interviewing for cerebral palsy, but Motivational Interviewing is generally considered safe as it is a counseling approach used to encourage behavior change and does not involve medication or physical interventions. ^{6 7 8 9 10}

How is Motivational Interviewing different from other treatments for cerebral palsy?

Motivational Interviewing is unique because it focuses on enhancing a person's motivation to change by exploring and resolving ambivalence, which is different from other treatments like physical therapies that focus on improving motor skills. This approach is more about communication and psychological support rather than physical intervention. ^{7 11 12 13 14}

What is the purpose of 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 is for individuals with cerebral palsy who have difficulty staying active. Participants should be able to use a wearable physical activity monitor. Specific inclusion and exclusion criteria are not provided, but typically these would detail the age range, severity of condition, and any other health requirements or restrictions.

Inclusion Criteria

I have cerebral palsy and can walk with or without assistance.

Exclusion Criteria

I haven't had bone surgery in the past 6 months.

I haven't had botulinum injections in the last 6 months.

No metal in their body that would preclude the use of MEG.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo neuroimaging and a battery of clinical assessments

1 week

Treatment

Participants receive 8 weeks of behavioral coaching to increase daily physical activity

8 weeks

3 visits per week (virtual or in-person)

Post-Treatment Assessment

Participants repeat the same assessments performed at baseline

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Motivational Interviewing

Trial Overview The study is testing whether motivational interviewing can help increase daily physical activity in people with cerebral palsy. Participants will receive behavioral coaching aimed at motivating them to be more active, monitored using wearable devices.

Participant Groups

Group I: Cerebral Palsy Youth/Young Adults Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Father Flanagan's Boys' Home

Lead Sponsor

Trials

14

Recruited

1,600+

Findings from Research

Motivational interviewing (MI) has shown a strong short-term effectiveness in promoting readiness for change, with an average effect size of 0.77 across 72 clinical trials, although this effect diminishes to 0.30 at follow-ups up to one year.

The effectiveness of MI is notably higher among ethnic minority populations and when not strictly following a manual, indicating that flexibility in its application may enhance its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing. Hettema, J., Steele, J., Miller, WR.[2022]

Motivational interviewing (MI) is an effective communication technique that helps patients engage in discussions about changing their health behaviors by addressing their ambivalence.

MI practitioners use specific skills and strategies to create a gap between a patient's current behaviors and their personal goals, facilitating a more productive conversation about health changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivating Behavioral Change. Tooley, EM., Kolahi, A.[2022]

Constraint-induced movement therapy (CIMT) is effective for improving unimanual skills in children with unilateral cerebral palsy, but it primarily supports implicit learning and may not adequately address the explicit learning needed for bimanual tasks.

Bimanual therapy complements CIMT by focusing on the use of both hands together, helping children recognize when to use two hands for tasks, thus enhancing their overall motor skills development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unimanual versus bimanual therapy in children with unilateral cerebral palsy: Same, same, but different. Hoare, B., Greaves, S.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Motivating Behavioral Change. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing as a prelude to coaching in healthcare settings. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effective Patient-Provider Communication in Pediatric Obesity. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Implementing motivational interviewing in a pediatric hospital. [2021]

6. Denmark pubmed.ncbi.nlm.nih.gov

Review of research on therapeutic interventions for children with cerebral palsy. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The adult with cerebral palsy. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Principles of Medical and Surgical Treatment of Cerebral Palsy. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Prevalence and functioning of children with cerebral palsy in four areas of the United States in 2006: a report from the Autism and Developmental Disabilities Monitoring Network. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Pain burden in children with cerebral palsy (CPPain) survey: Study protocol. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Navigating the Pathway to Care in Adults With Cerebral Palsy. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Unimanual versus bimanual therapy in children with unilateral cerebral palsy: Same, same, but different. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Multiple Treatments of Pediatric Constraint-Induced Movement Therapy (pCIMT): A Clinical Cohort Study. [2018]

14. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapies for individuals with cerebral palsy: A scoping review. [2023]