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
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
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
NCT ID
NCT02097836
First Posted
March 24, 2014
Last Updated
September 12, 2017
Sponsor
University of Oregon
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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