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Targeted Training for Trunk Control_case Series Cerebral Palsy (CP_TT)

Primary Purpose

Cerebral Palsy, Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Targeted Training
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring postural control, Targeted Training, cerebral palsy, trunk segments

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • neurologic diagnosis that results in a deficit in trunk control (i.e. cerebral palsy, traumatic brain injury)
  • age 4-17 years
  • Gross Motor Function Classification System (GMFCS) level III, IV or V for children with cerebral palsy

Exclusion Criteria:

  • spinal fixation
  • fixed scoliosis
  • uncontrolled seizures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single subject case series

    Arm Description

    Targeted training, 5-6 days a week for 6 months, minimum of 20 minutes per day

    Outcomes

    Primary Outcome Measures

    Change in Gross Motor Function Measure
    Probe data, balance
    timed balance task

    Secondary Outcome Measures

    Change in head stability
    Change in alignment and stability of head postural sway during quiet sitting
    Change in muscle activation strategy during quiet sitting with different levels of external support.
    Change in Pediatric Evaluation of Disability Inventory (PEDI)
    Qualitative Parent, Teacher report

    Full Information

    First Posted
    March 24, 2014
    Last Updated
    September 12, 2017
    Sponsor
    University of Oregon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02097836
    Brief Title
    Targeted Training for Trunk Control_case Series Cerebral Palsy
    Acronym
    CP_TT
    Official Title
    Segmental Training for Trunk Control a Pilot Study for Children With Moderate to Severe Motor Impairment.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    January 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Oregon

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    If a child with cerebral palsy does not develop independent sitting balance by 4 years of age, their prognosis for walking is very poor. Surprisingly little is known about how to facilitate head control or upright sitting balance and functional mobility in the child who is not developing these skills. This is one of the first studies that will examine intermediate stages in the development of the postural control system in children with neurologic deficits. Clinical researchers at The Movement Centre in Oswestry, England have developed a method called Targeted Training in which trunk control is trained in children segment by segment using a specific training device. This study aims to examine kinematic and electromyographic changes in a case series of children who undergo a 6-month Targeted Training intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Traumatic Brain Injury
    Keywords
    postural control, Targeted Training, cerebral palsy, trunk segments

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    Gross Motor Function Measure Outcome was masked for temporal order and video scored by reviewers who were not involved in data collections or intervention.
    Allocation
    N/A
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single subject case series
    Arm Type
    Experimental
    Arm Description
    Targeted training, 5-6 days a week for 6 months, minimum of 20 minutes per day
    Intervention Type
    Device
    Intervention Name(s)
    Targeted Training
    Intervention Description
    Custom training devices were imported from The Movement Centre for research purposes. The typical course of treatment involves loaning the customized equipment to each family for use in their home or in their child's educational setting. Training occurs once daily usually for 30-45 minutes. This is done 5 or 6 days per week. Training programs typically involve playing with balls or balloons or video games that motivate the child to hold the head erect and to wave the arms and hands and move the upper body.
    Primary Outcome Measure Information:
    Title
    Change in Gross Motor Function Measure
    Time Frame
    6 months and followup post training 12 months
    Title
    Probe data, balance
    Description
    timed balance task
    Time Frame
    baseline, intervention, 2 months post intervention
    Secondary Outcome Measure Information:
    Title
    Change in head stability
    Description
    Change in alignment and stability of head postural sway during quiet sitting
    Time Frame
    6 months, 1,3, and 12 months post intervention
    Title
    Change in muscle activation strategy during quiet sitting with different levels of external support.
    Time Frame
    6 months, 1 and 3 months post intervention
    Title
    Change in Pediatric Evaluation of Disability Inventory (PEDI)
    Time Frame
    6 months and 1,3, 12 months post intervention
    Title
    Qualitative Parent, Teacher report
    Time Frame
    during intervention and post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: neurologic diagnosis that results in a deficit in trunk control (i.e. cerebral palsy, traumatic brain injury) age 4-17 years Gross Motor Function Classification System (GMFCS) level III, IV or V for children with cerebral palsy Exclusion Criteria: spinal fixation fixed scoliosis uncontrolled seizures
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sandra L Saavedra, PhD
    Organizational Affiliation
    University of Oregon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Targeted Training for Trunk Control_case Series Cerebral Palsy

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