Developmental Powered Mobility for Cerebral Palsy

(DRIVE Trial)

Not yet recruiting at 1 trial location
HF
Overseen ByHeather Feldner, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to understand the effects of developmental powered mobility intervention on global development, gross motor function, and activity performance outcomes in 48 young children (ages 1-2 years) with cerebral palsy (CP). The main question it aims to answer is:

Does the developmental powered mobility intervention produce greater improvements in global development and activity performance outcomes in young children with CP?

How will the developmental powered mobility intervention effect gross motor function?

Researchers will compare the developmental powered mobility (DPM) intervention to usual care physical therapy focused on movement, orientation, repetition, and exercise (MORE-PT) to see if DPM produces greater improvements in outcomes without impeding gross motor function.

Child Participants will:

Receive either DPM or MORE-PT twice weekly for 12 weeks in the home setting.

Complete assessments with the interventionist before and after the 12-week intervention and at a 6-month follow-up visit.

Caregiver participants will: Track outside therapies and any outside assistive device use completed during the intervention, in a weekly log.

Who Is on the Research Team?

HF

Heather Feldner, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for young children aged 1-2 years diagnosed with cerebral palsy or similar nervous system disorders. Participants should be able to take part in home-based therapy sessions and have a caregiver who can help track their progress.

Inclusion Criteria

Child lives in a household where English or Spanish are spoken proficiently
Adult caregiver demonstrates proficiency in English or Spanish, confirmed via caregiver report using screening questions
My child has or is likely to have cerebral palsy with moderate motor challenges.
See 3 more

Exclusion Criteria

My child is older than 33 months.
My child regularly uses a power wheelchair or similar device at home.
My child does not have moderate to severe movement difficulties.

What Are the Treatments Tested in This Trial?

Interventions

  • Developmental Powered Mobility Intervention (DPM)

Trial Overview

The study compares two types of therapy: one group uses a powered mobility device (Permobil Explorer Mini) designed for young kids, while the other receives standard physical therapy focused on movement and exercise. Both groups get therapy twice weekly at home for 12 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Developmental Powered MobilityExperimental Treatment1 Intervention
Group II: MORE-PTActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+