• Overview
  • Eligibility
  • More info
  • Locations

A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE) (NCT02897024)

Patient-Centered Outcomes Research Institute
The ACHIEVE study is a comparison of the effectiveness of 2 intensities of physical therapy treatment for children with Cerebral Palsy in an outpatient physical therapy setting. High intensity periodic is 2 hours of focused and high intense treatment per weekday for 4 weeks. In comparison, usual weekly is considered standard of care; although both dosing models are used clinically for children with CP.
  • 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.
    Ages eligible for Study
    2 Years to 8 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • 2 to 8 years of age at initiation of treatment
    • a diagnosis of motor delay or CP in GMFCS levels 1-V
    • ability to tolerate a 2 hour therapy session based on parent report and evaluating therapists.
    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
    • family is unable to commit to the prescribed dose or follow up evaluations
    The overall goal of this project is to compare the effectiveness of high intense periodic and usual weekly therapy in treating Cerebral Palsy (CP) in children 2-8 years of age for motor rehabilitation. In this prospective randomized controlled trial (RCT), 300 children ages 2 to 8 years of age with CP will be enrolled and assigned to one of 2 service delivery models: 1 hour per day, 1 x per week for 40 weeks (usual weekly); and 2 hours every weekday for two 10-consecutive-weekdays (total 4 weeks), for a repeated "periodic" bout (high intense periodic). All patients enrolled in ACHIEVE will also have 1 hour per month of Physical Therapy Consultation (PTC) during the treatment period of 40 weeks (9 months). PTCs provide monthly motor skill monitoring, consultation, and home therapy program progression. Outcome evaluations will be performed by blinded evaluators at baseline (month 0, before treatment), month 9 for all patients to assess short term effects, and at months 12 and 18 for patients to assess long term effects. Parent surveys will be collected at 0, 4.5, and 9 months only (PC-2). Short-term and long-term effects will be analyzed to determine individual differences in children's response to intensity.

    1 locations

    United States (1)
    • Nationwide Children's Hospital
      recruiting
      Columbus, Ohio, United States, 43205
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    31 August, 2016
    Updated:
    17 January, 2017
    Participants:
    300
    Apply
    A girl giving information about available additional trials.

    FindMeCure helps you find, understand and join clinical trials from all over the world.

    There are more clinical trials for your condition!