Back to resultsEffect of Trunk Support on Academic Engagement of Children With Severe Disability
Primary Purpose
Cerebral Palsy, Traumatic Brain Injury, Metabolic Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
customized posture support
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring posture, trunk control, assistive device
Eligibility Criteria
Inclusion Criteria:
- Referral from physical, occupational or speech therapist working in Hartford Public School District or Connecticut Birth to Three,
- Segmental deficit in trunk control as measured by Segmental Assessment of Trunk Control
- parent or guardian consent that includes permission for video data collection and sharing of IEP (individualized education plan) or IFSP (individualized family support plan).
Exclusion Criteria:
- pain that interferes with positioning,
- impending surgery that will result in extended absence from school
Sites / Locations
- Children's Therapy Services, Connecticut Birth to Three
- Hartford Public Schools
- CREC, Connecticut Birth to Three
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Subject Design
Arm Description
The investigators will use a longitudinal design with baseline, immediate and post-intervention data collections. The intervention will include customized posture support in seated, standing or walking devices that will be used in the child's educational setting or home (for early intervention) to facilitate specific educational activities.
Outcomes
Primary Outcome Measures
Change in Video Behavior Coding of time "on task" for selected IEP or IFSP goals.
Frequency and duration of 'on task' behavior will be coded for 2 or 3 of the child's existing education goals under two conditions, when child is in usual positioning equipment and in segmentally optimized equipment. Goals of interest reflect motor behaviors that promote task performance or interaction. These include 1) eye gaze (at people or objects), 2) reaching, 3) object manipulation, 4) head turning and 5) making choices (using eye gaze or reach).
Secondary Outcome Measures
Change in vertical alignment of head
frequency and duration of upright 'head position' will be coded for 2 or 3 of the child's existing education goals under two conditions, when child is in usual positioning equipment and in segmentally optimized equipment.
parent, teacher or aide device use record
frequency and duration of device use and comments about child and teachers response to using the device.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05391594
Brief Title
Effect of Trunk Support on Academic Engagement of Children With Severe Disability
Official Title
Effect of Optimal Trunk Support on Academic Engagement of Children With Moderate to Severe Disability
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
October 3, 2019 (Actual)
Study Completion Date
October 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hartford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effect of optimizing trunk support based on segmental principles of trunk control, on academic engagement of children in academic settings.
Detailed Description
Head and trunk posture control are foundational skills, impacting vision, communication, swallowing, eating, reaching, and gait. Vision, communication and upper extremity skills are critical for participation in educational settings. From an academic point of view, participants with poor trunk stability have difficulties staying erect and keeping their head and trunk steady. This interferes with concentration, reduces ability and aptitude for learning and can lead to fatigue and reduced time on task. Examination of the effect of optimal trunk support may yield critical information regarding academic engagement in children with moderate to severe disability.
The investigators propose to facilitate use of a segmental approach by physical and occupational therapists in educational settings. Activities will include identifying level of trunk control and applying segmental principles to adapt participant's positioning devices for optimal function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Traumatic Brain Injury, Metabolic Disease, Hypotonia
Keywords
posture, trunk control, assistive device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Subject Research Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Subject Design
Arm Type
Experimental
Arm Description
The investigators will use a longitudinal design with baseline, immediate and post-intervention data collections. The intervention will include customized posture support in seated, standing or walking devices that will be used in the child's educational setting or home (for early intervention) to facilitate specific educational activities.
Intervention Type
Device
Intervention Name(s)
customized posture support
Intervention Description
We will provide customized modifications for seated or standing or walking devices based on the child's segmental level of control
Primary Outcome Measure Information:
Title
Change in Video Behavior Coding of time "on task" for selected IEP or IFSP goals.
Description
Frequency and duration of 'on task' behavior will be coded for 2 or 3 of the child's existing education goals under two conditions, when child is in usual positioning equipment and in segmentally optimized equipment. Goals of interest reflect motor behaviors that promote task performance or interaction. These include 1) eye gaze (at people or objects), 2) reaching, 3) object manipulation, 4) head turning and 5) making choices (using eye gaze or reach).
Time Frame
On day 1 and one additional date at least 3 weeks later.
Secondary Outcome Measure Information:
Title
Change in vertical alignment of head
Description
frequency and duration of upright 'head position' will be coded for 2 or 3 of the child's existing education goals under two conditions, when child is in usual positioning equipment and in segmentally optimized equipment.
Time Frame
On the day 1 and one additional date at least 3 weeks later.
Title
parent, teacher or aide device use record
Description
frequency and duration of device use and comments about child and teachers response to using the device.
Time Frame
from day 1 to second session at least 3 weeks later)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Referral from physical, occupational or speech therapist working in Hartford Public School District or Connecticut Birth to Three,
Segmental deficit in trunk control as measured by Segmental Assessment of Trunk Control
parent or guardian consent that includes permission for video data collection and sharing of IEP (individualized education plan) or IFSP (individualized family support plan).
Exclusion Criteria:
pain that interferes with positioning,
impending surgery that will result in extended absence from school
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Saavedra
Organizational Affiliation
University of Hartford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Therapy Services, Connecticut Birth to Three
City
Cheshire
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
Facility Name
Hartford Public Schools
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
Facility Name
CREC, Connecticut Birth to Three
City
Wethersfield
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
12. IPD Sharing Statement
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Effect of Trunk Support on Academic Engagement of Children With Severe Disability
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