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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2022
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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. Research questions include: 1.) What are the perceptions of children and caregivers about intensive therapy after participating in multiple intensive therapy episodes over time? 2.) Why do caregivers choose to continue with an intensive model of therapy periodically for their child with neurodevelopmental diagnoses? 3.) What were the outcomes for children with neurodevelopmental disabilities participating in an episode of intensive 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intensive therapy program
The intensive therapy program consists of physical therapy, occupational therapy, and speech therapy 3-6 hours x 4-5 days/week for 4 weeks. The individual therapies received will vary with the child/caregiver goals and be based on neuroplasticity and motor learning principles.

Locations

Country Name City State
United States University of Missouri Healthcare Children's Therapy Center Columbia Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

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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