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

January 29, 2025 updated by: Jill Heathcock, Ohio State University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Determining optimal frequency of treatment for young children with cerebral palsy (CP) has implications for shaping the future of pediatric rehabilitation. There are wide variations in the number of hours per week of treatment in current outpatient rehabilitation programs for children with CP, suggesting clinical uncertainty. Usual weekly therapy at 1 - 2 hours per week for 6 months or longer is the most commonly implemented frequency of dose for children with CP 6 - 24 months of age. However, this decision about frequency is often made based on clinical reasoning and scheduling, not on principles of rehabilitation, child development, or evidence from strongly designed randomized controlled trials. The proposed study will fill this gap by directly comparing the effects of 3 frequency levels of therapy - concentrated daily, intermediate, and usual weekly in children with CP 6 - 24 months of age at the initiation of treatment and following these patients for 2 years.

In this prospective longitudinal study, children with Cerebral Palsy (n=75), 6 - 24 months of age, will be randomly assigned to one of three groups: daily, intermediate, or weekly physical therapy. The treatment phase of this study design is 5 months for a total of 40 hours of one-on-one therapy for both groups. Level 1 daily therapy is 2 hours of therapy per day for 20 straight weekdays. Level 2 intermediate therapy is 2 hours of therapy per day 3 days per week for 6.6 weeks. Level 3 usual weekly therapy is 2 hours of therapy one day per week for 20 weeks. Researchers will directly compare the effects of 3 these frequency levels of therapy at the initiation of treatment and following these patients for 2 years. Results will provide quantitative evidence of frequency-response, which is critical for informing clinical decision-making, health policy, and guidelines for reimbursement.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • an age of 6 months - 24 months at the initiation of treatment. The age will be corrected for any eligible children born preterm until they are 2 years of age, as is standard clinical and research practice
  • a diagnosis or risk for CP in GMFCS levels III, IV and V or motor delay
  • ability to tolerate a 2 hour therapy session based on parent report and evaluating therapists, the same criteria the investigators used for the pilot study.

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
  • auditory, or visual conditions that prevent full participation during treatment sessions
  • progressive neurological disorder with no potential for improvement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Frequency Level 1 - Daily Therapy
Level 1 daily physical therapy is 2 hours of one-on-one physical therapy per day for 20 straight weekdays
Other: Physical Therapy
One-on-one physical therapy sessions (one therapist and one patient). Principles of motor learning used include repetition, task-specificity, active practice, generalization of skills, errors, structured practice, and developmentally appropriate feedback with sufficient time to practice.
Other: Frequency Level 2 - Intermediate Therapy
Level 2 intermediate physical therapy is 2 hours of therapy per day 3 days per week for 6.6 weeks
Other: Physical Therapy
One-on-one physical therapy sessions (one therapist and one patient). Principles of motor learning used include repetition, task-specificity, active practice, generalization of skills, errors, structured practice, and developmentally appropriate feedback with sufficient time to practice.
Other: Frequency Level 3 - Usual Therapy
Level 3 usual weekly physical therapy is 2 hours of therapy one day per week for 20 weeks.
Other: Physical Therapy
One-on-one physical therapy sessions (one therapist and one patient). Principles of motor learning used include repetition, task-specificity, active practice, generalization of skills, errors, structured practice, and developmentally appropriate feedback with sufficient time to practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gross Motor Function Measure (GMFM)-88
Time Frame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
GMFM evaluates change in gross motor function over time or with intervention in children with CP from 5 months to 16 years. It has been used widely in the field to determine functional motor change following intervention.
Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Goal Attainment Scaling (GAS)
Time Frame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
GAS creates patient, family, and clinical anchors as the external criterion for improvement by establishing activity or participation goals that reflect what an individual, family, and clinician consider meaningful or relevant.The GAS method allows for goals to be defined at different levels of mastery and assigned numerical values for score calculation, similar to a Likert scale. The scale will have 5 points representing different levels of mastery of the individual patient's goal. A score of -2 represents baseline, -1 less change than expected, 0 for the expected level of change, and +1 and +2 for achievement of more change than expected. To attempt to ensure ordinality, each level on the scale will be described and will reflect a single dimension of change that is measureable, achievable, and relevant
Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
Change in Bayley Scales of Infant Development III
Time Frame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
The Bayley Scales of Infant and Toddler Development-Third Edition is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior.
Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
Change in Pediatric Evaluation and Disability Inventory (PEDI)
Time Frame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
Administered as a parent survey. The PEDI is a descriptive measure of a child's current functional performance and can track changes over time. The PEDI measures both capability and performance of functional activities in three content domains: self-care, mobility, and social function.It can be used as a comprehensive clinical assessment of key functional capabilities and performance in children between the ages of six months and seven years.
Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Jill Heathcock, MPT, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

October 1, 2024

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimated)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015N0054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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