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Frequency Level 1 - Daily Therapy for Gross Motor Delay (DRIVE Trial)

N/A

Recruiting

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

DRIVE Trial 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.Check my eligibility

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.See study design

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.

DRIVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Gross Motor Function Measure (GMFM)-88

Secondary outcome measures

Change in Bayley Scales of Infant Development III

Change in Goal Attainment Scaling (GAS)

Change in Pediatric Evaluation and Disability Inventory (PEDI)

DRIVE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

829 Previous Clinical Trials

505,668 Total Patients Enrolled

Jill Heathcock, MPT, PhDPrincipal Investigator - Ohio State University

Ohio State University

2 Previous Clinical Trials

153 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being closely monitored in this clinical experiment?

"Affirmative. Data available on clinicaltrials.gov reveals that this research project, initially published in April 2016, is actively seeking enrolment of 75 patients from one medical centre."

Answered by AI

Are minors allowed to participate in the experiment?

"Individuals aged 6 months to 24 months are eligible for this trial, while those under 18 and over 65 may participate in 4 separate studies."

Answered by AI

Is it permissible for me to participate in this scientific research?

"This clinical trial requires the enrollment of 75 young patients with gross motor development delay, aged between 6 months old and 2 years (corrected for any preterm births). A two-hour therapy session must be tolerated by each participant in order to qualify. Additionally, participants are expected to have a diagnosis or risk for cerebral palsy at GMFCS levels III, IV or V as well as some kind of motor delay."

Answered by AI

Is registration still open for participation in this clinical investigation?

"Clinicaltrials.gov currently lists this medical study as open to recruitment; the trial was launched on April 1st 2016 and recently updated October 1st 2021."

Answered by AI

Recent research and studies

Pediatric Physical TherapyJournal

Daily and Weekly Rehabilitation Delivery for Young Children with Gross Motor Delay: A Randomized Clinical Trial Protocol (the DRIVE Study)

Ferrante, Rachel, Sarah Hendershot, Kathy Baranet, Gardenia Barbosa, Helen Carey, Nathalie Maitre, Warren Lo, Jeff Pan, and Jill Heathcock. 2019. “Daily and Weekly Rehabilitation Delivery for Young Children with Gross Motor Delay: A Randomized Clinical Trial Protocol (the DRIVE Study)”. Pediatric Physical Therapy. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pep.0000000000000594.

Pediatric Physical TherapyJournal

Parent-reported PEDI-CAT Mobility and Gross Motor Function in Infants with Cerebral Palsy

Scott, Kimberley, Jessica Lewis, Xueliang Pan, and Jill Heathcock. 2021. “Parent-reported PEDI-CAT Mobility and Gross Motor Function in Infants with Cerebral Palsy”. Pediatric Physical Therapy. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pep.0000000000000801.

clinicaltrials.govStudy

Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delays

Jill Heathcock 2016. "Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delays". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02857933.