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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help individuals with cerebral palsy become more active through motivational interviewing, a type of behavioral coaching. Researchers aim to determine if this coaching can increase the number of steps participants take each day, using wearable activity monitors to track progress. The trial targets those with cerebral palsy who can walk (with or without assistance) and have not undergone recent surgery or certain medical treatments. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance daily activity for individuals with cerebral palsy.

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 prior data suggests that motivational interviewing is safe for individuals with cerebral palsy?

Research has shown that Motivational Interviewing is generally safe, even without specific safety data for individuals with cerebral palsy. This method has been applied in various situations without major safety concerns. Motivational Interviewing involves conversations to help individuals find motivation to change behavior. It does not involve medication or physical procedures, making it low risk for side effects. Thus, despite the lack of specific data for cerebral palsy, the overall safety profile of Motivational Interviewing remains positive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for cerebral palsy focus on physical therapy, medications to manage symptoms, or surgical interventions. However, Motivational Interviewing (MI) is unique because it emphasizes improving self-motivation and behavioral change through guided conversations. Unlike traditional methods, MI doesn't directly address physical symptoms but instead empowers individuals with cerebral palsy to engage more actively in their treatment and personal goals, potentially enhancing overall quality of life. Researchers are excited about MI because it represents a non-invasive, supportive approach that could complement existing therapies and lead to better long-term outcomes for youth and young adults facing this condition.

What evidence suggests that motivational interviewing is effective for increasing physical activity in individuals with cerebral palsy?

Research has shown that motivational interviewing, which participants in this trial will receive, can help people with cerebral palsy become more active. This method aids individuals in setting personal goals and provides support to change habits. One study found that combining motivational interviewing with coaching increased movement in people with cerebral palsy. This approach centers on understanding what motivates a person to make positive changes. Overall, motivational interviewing has helped people become more active, leading to better health. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5629713/

ParticiPAte CP: a protocol of a randomised waitlist ... ParticiPAte CP is an individualised, goal-directed, family centred, ecological, participation-based and motivational physiotherapy intervention.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06852664

Improving Activity in Individuals With Cerebral Palsy (Fitbit) ... data for the primary outcome measure ... motivational interviewing and coaching are effective in increasing movement in populations with cerebral palsy.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/cch.13301

Effectiveness of therapeutic interventions on participation ... The aim of this systematic review is to determine the effectiveness of therapeutic interventions on participation outcomes of children with cerebral palsy (CP).

4. withpower.com withpower.com/trial/phase-paralysis-2-2025-3c24b

Motivational Interviewing for Cerebral Palsy (Fitbit Trial) Motivational Interviewing (MI) has been shown to be effective in helping people change behaviors across various conditions, with a meta-analysis of 72 clinical ...

5. archives-pmr.org archives-pmr.org/article/S0003-9993(18)31518-1/abstract

Efficacy of Participation-Focused Therapy on Performance ... ParticiPAte CP was effective at increasing perceived performance of leisure-time physical activity goals in children with CP GMFCS I-III by ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23550896/

Evidence for outcomes of motivational rehabilitation ... This study reviewed evidence regarding the effect of motivational rehabilitation interventions on outcomes in children with cerebral palsy.

7. researchgate.net researchgate.net/publication/41563160_Motivational_Interviewing_to_promote_self-awareness_and_engagement_in_rehabilitation_following_acquired_brain_injury_A_conceptual_review

Motivational Interviewing to promote self-awareness and ... (PDF) Motivational Interviewing to promote self-awareness and engagement in rehabilitation following acquired brain injury: A conceptual review.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dmcn.13413

The efficacy of interventions to increase physical activity ... Meta-analysis reveals therapy and behaviour change interventions have a modest but clinically insignificant effect on habitual physical ...

9. bmjopen.bmj.com bmjopen.bmj.com/content/7/8/e015918

ParticiPAte CP: a protocol of a randomised waitlist ... ... Motivational Interviewing. The intervention comprises 8 weekly sessions of 1 hour duration conducted by a physiotherapist in the child's home or community ...