Neurodevelopmental Disorders Clinical Trial
Official title:
The Experience of Participating in a Pediatric Summer Intensive Therapy Program--A Mixed Methods Study
NCT number | NCT04891328 |
Other study ID # | 2058022 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 24, 2021 |
Est. completion date | October 1, 2021 |
Verified date | March 2022 |
Source | University of Missouri-Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to explore the lived experiences of children with neurodevelopmental diagnoses and their caregivers with an intensive model of therapy. Children will receive usual care during the summer intensive program and the investigators will access medical records to assess effectiveness. Children and caregivers will also be asked to participate in semi-structured interviews upon the completion of the episode of care.
Status | Completed |
Enrollment | 13 |
Est. completion date | October 1, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 15 Years |
Eligibility | Inclusion Criteria: - Children receiving therapy through the Children's Therapy Center's Tiger Intensive Program and their caregivers from May 24 to August 13 2021. Exclusion Criteria: - n/a |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri Healthcare Children's Therapy Center | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Semi-structured interviews | Upon completion of the program, children and caregivers will participate in an interview about their experience | at discharge assessed up to 10 days | |
Primary | Canadian Occupational Performance Measure | Individualized client-centered performance measure | measured at discharge 4 weeks after enrollment | |
Secondary | Change in Lower extremity passive range of motion | Measured at ankle, knee, and hip with goniometer | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in Thomas Test | Hip flexor length test | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in popliteal angle | Hamstring length test | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in Gastrocnemius muscle length | Measured with goniometer | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in Kids Bestest | Balance measure for pediatric patients | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in m-CTSIB | Balance measure | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in Early Clinical Assessment of Balance | Balance measure | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in Segmental Assessment of Trunk Control (SATCO) | Measurement of trunk control | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in Edinburgh Visual Gait Scale | Observational Gait measure | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in Timed Up and Down Stairs | Measure of stair performance | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in Timed on and off the floor | Measure of transition from floor to standing | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in 6 minute walk test | Measure of walking performance | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in Peds QL | Pediatric quality of life measure | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in GOAL | patient reported measure of function mobility | Measured at day 1 and discharge 4 weeks later | |
Secondary | Change in Pediatric Evaluation of Disability Inventory | Measure of amount of disability | Measured at day 1 and discharge 4 weeks later | |
Secondary | Pediatric Balance Scale | Measure of balance | Measured at day 1 and discharge 4 weeks later |
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