Clinical trial NCT05391594: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Traumatic Brain Injury
Metabolic Disease
Hypotonia
Keywords: posture
trunk control
assistive device
Lead sponsor: University of Hartford
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Subject Research Design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Video Behavior Coding of time "on task" for selected IEP or IFSP goals.
timeFrame: On day 1 and one additional date at least 3 weeks later.
Secondary outcomes:
measure: Change in vertical alignment of head
timeFrame: On the day 1 and one additional date at least 3 weeks later.
measure: parent, teacher or aide device use record
timeFrame: from day 1 to second session at least 3 weeks later)
Other outcomes:
Locations:
city: Cheshire
country: United States
facility: Children's Therapy Services, Connecticut Birth to Three
state: Connecticut
city: Hartford
country: United States
facility: Hartford Public Schools
state: Connecticut
city: Wethersfield
country: United States
facility: CREC, Connecticut Birth to Three
state: Connecticut
Study officials:
affiliation: University of Hartford
name: Sandra Saavedra
role: PRINCIPAL_INVESTIGATOR
References: