Clinical trial NCT02857933: Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delays
Official title: Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delays
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gross Motor Development Delay
Keywords: Motor Impairments
Gross Motor Delay
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Gross Motor Function Measure (GMFM)-88
timeFrame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
Secondary outcomes:
measure: Change in Goal Attainment Scaling (GAS)
timeFrame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
measure: Change in Bayley Scales of Infant Development III
timeFrame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
measure: Change in Pediatric Evaluation and Disability Inventory (PEDI)
timeFrame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jill Heathcock, MPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.