Powered Mobility for Cerebral Palsy

Not yet recruiting at 2 trial locations

Overseen By Bethany M Sloane, PT, DPT, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Inability, unwillingness to consent, others

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

Compensation: Varies

Number of Visits: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a training program can help therapists effectively use powered mobility devices with young children who have cerebral palsy. The goal is to determine if these devices improve the children's mobility and participation in daily activities and if families find them helpful. It targets children diagnosed with cerebral palsy who struggle with movement (classified as Levels IV-V) and are currently receiving early intervention services. Therapists and caregivers will receive training and then collaborate to integrate powered mobility into the child’s daily routine.

As an unphased trial, this study offers families a unique opportunity to contribute to innovative approaches that may enhance their child's mobility and daily life.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on training and using powered mobility devices, so it's unlikely that medication changes are required.

What prior data suggests that this therapist training program is safe for use in early childhood settings?

Research has shown that powered mobility devices can be safe and helpful for young children with cerebral palsy. One study found that using these devices improved children's growth and involvement in daily activities, indicating that children can handle powered mobility well and benefit from it.

Another study with 24 child-caregiver pairs showed positive results without major safety concerns, suggesting that the intervention is generally well-accepted.

Therapists receive structured, evidence-based training to ensure that both children and their caregivers can use these devices safely in everyday life.

Overall, the research supports the safety and potential benefits of powered mobility for young children with cerebral palsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the powered mobility intervention for children with cerebral palsy because it offers a fresh approach to enhancing mobility and daily life integration. Unlike traditional treatments that might focus solely on physical therapy or static mobility aids, this intervention uses the Permobil Explorer Mini, a powered device, to actively engage young children and their caregivers in real-world settings. The method emphasizes not just physical mobility but also caregiver coaching and personalized integration into daily routines, potentially leading to more holistic improvements in the child's quality of life.

What evidence suggests that this therapist training program is effective for using powered mobility with young children who have cerebral palsy?

Research shows that powered mobility devices can greatly help young children with cerebral palsy. Studies have found that using devices like the Permobil Explorer Mini for a short time can boost development and help kids take part in daily activities. Children using these devices have demonstrated better movement skills and increased involvement in their surroundings. In this trial, all participants will receive the powered mobility intervention, which includes therapist training. Training programs for therapists have effectively taught them how to use these devices with children. This combination of devices and proper therapist training, as implemented in this trial, can positively affect children with cerebral palsy by improving their movement and participation. ^{1 2 3 4 6}

Who Is on the Research Team?

Bethany M Sloane, PT, DPT, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for young children with cerebral palsy (GMFCS Levels IV-V) who are in early childhood settings. Therapists and caregivers will be trained to use powered mobility devices with these children. Participants must be involved in Part C Early Childhood programs, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am a licensed therapist in early childhood settings, new to powered mobility training but willing to learn for children with cerebral palsy.

I am over 18, speak English or Spanish, and can do home-based tasks for a child's study.

My child has severe cerebral palsy, is between 1-3 years old, and is in early intervention.

Exclusion Criteria

None beyond inability or unwillingness to provide informed consent or complete study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Therapists participate in one to two days of in-person training to learn how to implement the powered mobility intervention

1 week

1-2 visits (in-person)

Intervention

Therapists conduct twelve biweekly home-based intervention sessions focusing on mobility opportunities, caregiver coaching, and integration of powered mobility into daily routines

6 months

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Powered Mobility Intervention for Child-Caregiver Dyads
• Therapist Training on Powered Mobility Implementation

Trial Overview The study tests a therapist training program on powered mobility for kids with cerebral palsy. It evaluates the practicality of the training, its acceptance by families and therapists, and observes improvements in child mobility, participation, and engagement using Permobil Explorer Mini devices.

How Is the Trial Designed?

Group I: Powered Mobility Intervention Experimental Treatment 2 Interventions

This mixed-methods feasibility trial includes one experimental arm in which all participants receive the powered mobility intervention following a structured therapist training. Trained physical and occupational therapists participate in one to two days of in-person training to learn how to implement the intervention with children with cerebral palsy (GMFCS IV-V) and their caregivers in early childhood settings. Following training, therapists identify eligible child-caregiver dyads from their caseloads and conduct twelve biweekly home-based intervention sessions over six months. Each session focuses on mobility opportunities, caregiver coaching, and integration of powered mobility into daily routines using the Permobil Explorer Mini device. All sessions are video recorded for fidelity monitoring and qualitative analysis.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07220590

Implementing Powered Mobility in Early Childhood ... Therapists participate in a structured, evidence-based training on implementing powered mobility interventions for children with cerebral palsy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9338708/

In the Driver's Seat: A Randomized, Crossover Clinical ... This study is significant because it aims to understand the effect of a powered mobility intervention on the developmental and participation outcomes of young ...

3. researchgate.net researchgate.net/publication/385252980_Short-Term_Powered_Mobility_Intervention_is_Associated_With_Improvements_in_Development_and_Participation_for_Young_Children_with_Cerebral_Palsy_A_Randomized_Clinical_Trial

Short-Term Powered Mobility Intervention Is Associated ... Conclusion Short-term powered mobility intervention may advance multiple domains of development and participation for young children with cerebral palsy.

4. ir.library.oregonstate.edu ir.library.oregonstate.edu/downloads/vq27zx19m

The Impact of Powered Mobility Use on Expressive ... The study aims to understand and explore the expressive communication changes of young children (12-36 months) with mobility challenges due to ...

5. resna.org resna.org/sites/default/files/conference/2018/wheelchair_seating/Khaton.html

Exploring The Use Of A New Power Mobility Training ... Improvement in all 4-power mobility foundational skills and in PMS scores post-intervention suggests the effectiveness of this training program and highlights ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39450982/

Short-Term Powered Mobility Intervention Is Associated With ... Short-term powered mobility intervention may advance multiple domains of development and participation for young children with cerebral palsy.