Physical Therapy for Gross Motor Delays
(DRIVE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJill Heathcock, MPT, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ohio State University

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine the optimal frequency and intensity of physical therapy for children with cerebral palsy aged 6 to 24 months of age. Participants will be randomly assigned to one of three groups: daily, intermediate, or weekly physical therapy. Short and long term effects will be evaluated to determine the best 'dose' of rehabilitation for children with cerebral palsy, including frequency (number of sessions per week and the number of weeks), intensity (how hard the patient works), and time (how many total hours) of rehabilitation treatment.

Eligibility Criteria

This trial is for young children aged 6 to 24 months with cerebral palsy or gross motor delays, specifically in GMFCS levels III-V. They must be able to handle a 2-hour therapy session and not be enrolled in another daily treatment program. Children with progressive neurological disorders, uncontrollable seizures, or sensory conditions that limit participation are excluded.

Inclusion Criteria

My child is between 6 months and 2 years old, adjusted for premature birth.

I can handle a 2-hour therapy session, as confirmed by my parent and therapist.

I have cerebral palsy or am at risk, with moderate to severe mobility issues.

Exclusion Criteria

Uncontrollable seizures or any co-morbid condition that prevents full participation during treatment sessions

Participation in another daily treatment program in the last 6 months

I do not have hearing or vision problems that would stop me from fully participating in treatment.

+1 more

Participant Groups

The study aims to find the best frequency and intensity of physical therapy for children with cerebral palsy by comparing three groups: one receiving daily sessions, one intermediate frequency, and one weekly. The 'dose' of rehabilitation will consider the number of sessions per week, overall duration, and intensity.

3Treatment groups

Experimental Treatment

Group I: Frequency Level 3 - Usual TherapyExperimental Treatment1 Intervention

Level 3 usual weekly physical therapy is 2 hours of therapy one day per week for 20 weeks.

Group II: Frequency Level 2 - Intermediate TherapyExperimental Treatment1 Intervention

Level 2 intermediate physical therapy is 2 hours of therapy per day 3 days per week for 6.6 weeks

Group III: Frequency Level 1 - Daily TherapyExperimental Treatment1 Intervention

Level 1 daily physical therapy is 2 hours of one-on-one physical therapy per day for 20 straight weekdays