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Trial record 2 of 155 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

Daily and Weekly Rehabilitation Delivery for Young Children With Cerebral Palsy (DRIVE)

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ClinicalTrials.gov Identifier: NCT02857933
Recruitment Status : Recruiting
First Posted : August 5, 2016
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Jill Heathcock, Ohio State University

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Daily and Weekly Rehabilitation Delivery for Young Children With Cerebral Palsy
Study Start Date : April 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Frequency Level 1 - Daily Therapy
Level 1 daily therapy is 2 hours of one-on-one physical therapy per day for 20 straight weekdays
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.

Frequency Level 2 - Intermediate Therapy
Level 2 intermediate therapy is 2 hours of therapy per day 3 days per week for 6.6 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.

Frequency Level 3 - Usual Therapy
Level 3 usual weekly therapy is 2 hours of therapy one day per week for 20 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.




Primary Outcome Measures :
  1. Change in Gross Motor Function Measure (GMFM)-88 [ Time Frame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment ]
    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.


Secondary Outcome Measures :
  1. Change in Goal Attainment Scaling (GAS) [ Time Frame: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after 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 3 months, 6 months, 12 months, 18 months, and 24 months after 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 3 months, 6 months, 12 months, 18 months, and 24 months after 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.



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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • the family is unable to commit to the prescribed dose or follow up evaluations.

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): NCT02857933


Contacts
Contact: Sarah Landry, MPH 614-572-5446 Sarah.Landry@osumc.edu

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Sarah Landry, MPH    614-572-5446    Sarah.Landry@osumc.edu   
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Jill Heathcock, MPT, PhD Ohio State University

Responsible Party: Jill Heathcock, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02857933     History of Changes
Other Study ID Numbers: 2015N0054
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Keywords provided by Jill Heathcock, Ohio State University:
cerebral palsy
motor impairments

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases