Cerebral PalsyNCT05391594
Effect of Trunk Support on Academic Engagement of Children With Severe Disability
A study testing customized posture support in people with Cerebral Palsy and Traumatic Brain Injury, run by University of Hartford at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 3 months to 21 years
- Conditions the study is for
- Cerebral Palsy, Traumatic Brain Injury, Metabolic Disease
- What is being tested?
- customized posture support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 May 2018to 3 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- pain that interferes with positioning,
- impending surgery that will result in extended absence from school
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Therapy Services, Connecticut Birth to Three
Cheshire, Connecticut, 06117
Hartford Public Schools
Hartford, Connecticut, 06117
CREC, Connecticut Birth to Three
Wethersfield, Connecticut, 06117
About this study
Official title: Effect of Optimal Trunk Support on Academic Engagement of Children With Moderate to 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.
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.
- Conditions
- Cerebral Palsy, Traumatic Brain Injury, Metabolic Disease, Hypotonia
- Being tested
- customized posture support
- Keywords
- posture, trunk control, assistive device
- Medical subject headings
- Cerebral Palsy, Brain Injuries, Traumatic, Metabolic Diseases, Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customized posture supportDevice
We will provide customized modifications for seated or standing or walking devices based on the child's segmental level of control
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: customized posture support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: On day 1 and one additional date at least 3 weeks later.
Secondary outcomes (2)
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.
Measured: On the day 1 and one additional date at least 3 weeks later.
parent, teacher or aide device use record
frequency and duration of device use and comments about child and teachers response to using the device.
Measured: from day 1 to second session at least 3 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start31 May 2018
- Primary completion3 Oct 2019
- Study completion3 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Subject Research Design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hartford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Saavedra, Principal investigator, University of Hartford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391594
- Sponsor's protocol ID
- PRO18010001
- Status last verified
- May 2022
- First submitted
- 26 Nov 2018
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Optimal Trunk Support on Academic Engagement of Children With Moderate to Severe Disability
- ClinicalTrials.gov ID
- NCT05391594
- Acronym / sponsor ID
- PRO18010001
- Conditions
- Cerebral Palsy, Traumatic Brain Injury, Metabolic Disease, Hypotonia
- Keywords
- posture, trunk control, assistive device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of HartfordUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Subject Research Design
| Arm | Type | Receives |
|---|---|---|
| Single Subject Design | Experimental | Device: customized posture supportThe 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. |
Who may qualify
- Ages
- 3 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- pain that interferes with positioning,
- impending surgery that will result in extended absence from school
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| customized posture supportWe will provide customized modifications for seated or standing or walking devices based on the child's segmental level of control | Device | Single Subject Design |
Primary outcome
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).
2 secondary outcomes
Change in vertical alignment of head
Time frame: On the day 1 and one additional date at least 3 weeks later.
parent, teacher or aide device use record
Time frame: from day 1 to second session at least 3 weeks later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Saavedra principal investigator
University of Hartford
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing customized posture support in people with Cerebral Palsy and Traumatic Brain Injury, run by University of Hartford at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.