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

NCT02857933 | Active Not Recruiting DMC

• 1 other identifier: 2015N0054
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Gross Motor Development Delay

Keywords

Motor Impairments; Gross Motor Delay

Outcome Measures

Primary Outcomes (1)

• Change in Gross Motor Function Measure (GMFM)-88

  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 Outcomes (3)

• Change in Goal Attainment Scaling (GAS)

  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

  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)

  Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment

Study Arms (3)

Frequency Level 1 - Daily Therapy

OTHER

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

Other: Physical Therapy

Frequency Level 2 - Intermediate Therapy

OTHER

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

Other: Physical Therapy

Frequency Level 3 - Usual Therapy

OTHER

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

Other: Physical Therapy

Interventions

Physical Therapy 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 1 - Daily Therapy; Frequency Level 2 - Intermediate Therapy; Frequency Level 3 - Usual Therapy

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

• 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.

  PMID: 34086623 DERIVED

• 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.

  PMID: 30865149 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Jill Heathcock, MPT, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: August 5, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)