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Completed

NCT Number: NCT05391594

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

This study evaluates the effect of optimizing trunk support based on segmental principles of trunk control, on academic engagement of children in academic settings.

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Key information

Age range

3 month–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Therapy Services, Connecticut Birth to Three, Cheshire, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in Video Behavior Coding of time "on task" for selected IEP or IFSP goals.

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

    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).

Secondary outcomes

  1. Change in vertical alignment of head

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

    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.

  2. parent, teacher or aide device use record

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

    frequency and duration of device use and comments about child and teachers response to using the device.

Sponsors and collaborators

Lead sponsor

University of Hartford

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 26, 2022
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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