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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Ohio State University

Current Primary Outcome: Change in Gross Motor Function Measure (GMFM)-88 [ Time Frame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment. ]

GMFM evaluates change in gross motor function over time or with intervention in children


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Goal Attainment Scaling (GAS) [ Time Frame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following 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
  • Change in Bayley Scales of Infant Development III [ Time Frame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following 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.
  • Change in Pediatric Evaluation and Disability Inventory (PEDI) [ Time Frame: Baseline (pre-treatment) and 9 months 12 months, and 18 months following 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.


Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: September 7, 2016
Date Started: September 2016
Date Completion: September 2020
Last Updated: January 18, 2017
Last Verified: January 2017