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

NCT ID: NCT02857933

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2026-04-30

Brief Summary

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.

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.

Conditions

Gross Motor Development Delay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: OTHER

Physical Therapy

Intervention Type: OTHER

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.

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

Group Type: OTHER

Physical Therapy

Intervention Type: OTHER

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.

Frequency Level 3 - Usual Therapy

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

Group Type: OTHER

Physical Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Jill Heathcock

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill Heathcock, MPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

References

Scott K, Lewis J, Pan X, Heathcock J. Parent-Reported PEDI-CAT Mobility and Gross Motor Function in Infants With Cerebral Palsy. Pediatr Phys Ther. 2021 Jul 1;33(3):156-161. doi: 10.1097/PEP.0000000000000801.

Reference Type: DERIVED

PMID: 34086623 (View on PubMed)

Ferrante R, Hendershot S, Baranet K, Barbosa G, Carey H, Maitre N, Lo W, Pan J, Heathcock J. Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delay: A Randomized Clinical Trial Protocol (the DRIVE Study). Pediatr Phys Ther. 2019 Apr;31(2):217-224. doi: 10.1097/PEP.0000000000000594.

Reference Type: DERIVED

PMID: 30865149 (View on PubMed)

Other Identifiers

2015N0054

Identifier Type: -

Identifier Source: org_study_id