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

NCT05391594 | Completed FDA Device

• 1 other identifier: PRO18010001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Cerebral Palsy; Traumatic Brain Injury; Metabolic Disease; Hypotonia

Keywords

posture; trunk control; assistive device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in vertical alignment of head

  On the day 1 and one additional date at least 3 weeks later.

• parent, teacher or aide device use record

  from day 1 to second session at least 3 weeks later)

Study Arms (1)

Single Subject Design

EXPERIMENTAL

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.

Device: customized posture support

Interventions

customized posture support DEVICE

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

Single Subject Design

Eligibility Criteria

• Age: 3 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• pain that interferes with positioning,
• impending surgery that will result in extended absence from school

Sponsors & Collaborators

• University of Hartford: lead

Study Sites (3)

Children's Therapy Services, Connecticut Birth to Three

Cheshire, Connecticut, 06117, United States

Location

Hartford Public Schools

Hartford, Connecticut, 06117, United States

Location

CREC, Connecticut Birth to Three

Wethersfield, Connecticut, 06117, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries, Traumatic; Metabolic Diseases; Muscle Hypotonia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Nutritional and Metabolic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Saavedra

  University of Hartford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Subject Research Design

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: May 26, 2022
• Study Start: May 31, 2018
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

US (3)