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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05391594
Other study ID # PRO18010001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2018
Est. completion date October 3, 2019

Study information

Verified date May 2022
Source University of Hartford
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date October 3, 2019
Est. primary completion date October 3, 2019
Accepts healthy volunteers No
Gender All
Age group 3 Months to 21 Years
Eligibility 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

Study Design


Intervention

Device:
customized posture support
We will provide customized modifications for seated or standing or walking devices based on the child's segmental level of control

Locations

Country Name City State
United States Children's Therapy Services, Connecticut Birth to Three Cheshire Connecticut
United States Hartford Public Schools Hartford Connecticut
United States CREC, Connecticut Birth to Three Wethersfield Connecticut

Sponsors (1)

Lead Sponsor Collaborator
University of Hartford

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). On day 1 and one additional date at least 3 weeks later.
Secondary 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. On the day 1 and one additional date at least 3 weeks later.
Secondary parent, teacher or aide device use record frequency and duration of device use and comments about child and teachers response to using the device. from day 1 to second session at least 3 weeks later)
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