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

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ClinicalTrials.gov Identifier: NCT02897024
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Jill Heathcock, Ohio State University

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. Participants are assign to the treatment group at random. Participant who are unable to consent to randomization are allowed to chose a treatment group.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Physical Therapy Not Applicable

Detailed Description:
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), 108 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). Participants unable to consent to randomization are allowed to chose a treatment group. 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. A subset will be analyzed at 12 and 18 month.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE)
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual weekly
Usual weekly physical therapy is 1 hours of therapy one day per week for 40 weeks.
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.

Experimental: High intensity periodic
High intensity periodic physical therapy is 2 hours of therapy 5 days a week for 2 weeks, followed by an 18 week break, followed by another bout of high intensity therapy for 2 hours of therapy every weekday for two 10-consecutive-weekdays, followed by another 18 week break from therapy.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Other Outcome Measures:
  1. Change in Pediatric Outcomes Questionnaire (PODCI) [ Time Frame: Collected at 0, 4.5 and 9 months (during the treatment period) ]
    Parent survey to assess patients under the age of 19 years for overall health, pain, and ability to participate in normal daily activities, as well as more vigorous activities typically associated with young people. The target populations are children and adolescents ages 2-18 years with general health problems, specifically any problems related to bone and muscle conditions.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Progressive neurological disorder with no potential for improvement.
  • Recent surgery where physical therapy is contraindicated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897024


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Ohio State University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Jill Heathcock, MPT, PhD Ohio State University
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Responsible Party: Jill Heathcock, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02897024    
Other Study ID Numbers: 2016N0031
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Keywords provided by Jill Heathcock, Ohio State University:
Cerebral Palsy
Motor Impairments
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases