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Physical Therapy for Gross Motor Delays (DRIVE Trial)

N/A
Waitlist Available
Led By Jill Heathcock, MPT, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how often and how intense physical therapy should be for young kids with cerebral palsy, to find the best 'dose' of rehabilitation.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves physical therapy as an intervention rather than medication, side effects may include muscle soreness or fatigue due to exercise. However specific side effects are not detailed here.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Gross Motor Function Measure (GMFM)-88
Secondary study objectives
Change in Bayley Scales of Infant Development III
Change in Goal Attainment Scaling (GAS)
Change in Pediatric Evaluation and Disability Inventory (PEDI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
870 Previous Clinical Trials
654,981 Total Patients Enrolled
Jill Heathcock, MPT, PhDPrincipal Investigator - Ohio State University
Ohio State University
2 Previous Clinical Trials
153 Total Patients Enrolled
~8 spots leftby Dec 2025
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