Effect of Trunk Support on Academic Engagement of Children With Severe Disability

Cerebral Palsy Clinical Trial

Official title:

Effect of Optimal Trunk Support on Academic Engagement of Children With Moderate to Severe Disability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05391594
• Other study ID #: PRO18010001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cerebral Palsy
• Hypotonia
• Metabolic Disease
• Metabolic Diseases
• Muscle Hypotonia
• Traumatic Brain Injury

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)