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CompletedNCT05391594Updated May 26, 2022

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

An interventional study of customized posture support in Cerebral Palsy, Traumatic Brain Injury and Metabolic Disease, sponsored by University of Hartford. Completed at 3 sites in United States. Open to participants aged 3 Months to 21 Years. Per ClinicalTrials.gov, last updated 2022-05-26.

Sponsored by University of Hartford · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2019, 7 years ago, and no results have been posted to the registry.
  • Registered 5 months after the study started (first participant enrolled May 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
3 Months to 21 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy
  • Traumatic Brain Injury
  • Metabolic Disease
  • Hypotonia

Keywords

  • posture
  • trunk control
  • assistive device
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 10 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University of Hartford is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • pain that interferes with positioning,
  • impending surgery that will result in extended absence from school
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Single Subject Design

    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

  • Devicecustomized posture support

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

06

What researchers measure

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).

    Time frame: On day 1 and one additional date at least 3 weeks later.

Secondary outcomes

  1. 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.

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

  2. parent, teacher or aide device use record

    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)

07

Study locations

3 sites
  • Children's Therapy Services, Connecticut Birth to Three
    Cheshire, Connecticut 06117, United States
  • Hartford Public Schools
    Hartford, Connecticut 06117, United States
  • CREC, Connecticut Birth to Three
    Wethersfield, Connecticut 06117, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05391594
Lead sponsor
University of Hartford
Responsible party
Sponsor
First posted
May 26, 2022
Start date
May 31, 2018
Primary completion
Oct 3, 2019
Completion
Oct 3, 2019
Last update
May 26, 2022

Study contacts

Sandra Saavedra
principal investigator · University of Hartford

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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