- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05443763
Exploring the Experiences and Outcomes of a Summer Intensive Therapy Program- Mixed Methods Study
March 22, 2023 updated by: Jamie Hall, University of Missouri-Columbia
The purpose of this study is to assess the effectiveness of an interdisciplinary intensive therapy program for ambulatory and non-ambulatory children with neurodevelopmental disorders across the ICF and to explore caregiver experiences and perspectives of the program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to assess the effectiveness of an interdisciplinary intensive therapy program for ambulatory and non-ambulatory children with neurodevelopmental disorders across the ICF and to explore caregiver experiences and perspectives of the program.
Research questions include: 1.) What are the effects of an intensive program on postural control and functional mobility for children with neurodevelopmental disorders?
2.) What are the effects of an intensive therapy program on dual tasking for children with neurodevelopmental disorders?
3.) What are the perceptions of caregivers of a multidisciplinary intensive therapy program for their children with neurodevelopmental disorders?
Data will be gathered before and after the intensive program as part of usual care and ambulatory children will be further assessed in the motion analysis lab.
Caregivers will complete a questionnaire about satisfaction with services and also a 4 question open-ended question survey about their experience with intensive therapy.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jamie B Hall, PT, DPT, PhD
- Phone Number: 5738827103
- Email: halljami@health.missouri.edu
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65201
- Children's Therapy Center--MU Healthcare
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children receiving therapy through Children's Therapy Center's Tiger Intensive Program and their caregivers from May 23, 2022, to Aug 19, 2022.
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Instrumented Gait Analysis
Time Frame: before intensive therapy episode of care, approximately 4 weeks
|
3D gait analysis in gait lab
|
before intensive therapy episode of care, approximately 4 weeks
|
Instrumented Gait Analysis
Time Frame: after intensive therapy episode of care, approximately 4 weeks
|
3D gait analysis in gait lab
|
after intensive therapy episode of care, approximately 4 weeks
|
Center of pressure measure
Time Frame: after intensive therapy episode of care, approximately 4 weeks
|
COP measure during balance task
|
after intensive therapy episode of care, approximately 4 weeks
|
Center of pressure measure
Time Frame: before intensive therapy episode of care, approximately 4 weeks
|
COP measure during balance task
|
before intensive therapy episode of care, approximately 4 weeks
|
Measures of processes of care (MOPC)
Time Frame: after intensive therapy episode of care, an average of 4 weeks
|
Questionnaire to assess satisfaction with therapy services
|
after intensive therapy episode of care, an average of 4 weeks
|
Timed up and go
Time Frame: before intensive therapy episode of care, an average of 4 weeks
|
TUG assessment--timed assessment including standing from a chair, walking a distance and returning to the chair
|
before intensive therapy episode of care, an average of 4 weeks
|
Timed up and go
Time Frame: fter intensive therapy episode of care, an average of 4 weeks
|
TUG assessment--timed assessment including standing from a chair, walking a distance and returning to the chair
|
fter intensive therapy episode of care, an average of 4 weeks
|
Modified Clinical Test of Sensory Integration and Balance
Time Frame: after intensive therapy episode of care, an average of 4 weeks
|
mCISIB--balance test in 4 conditions
|
after intensive therapy episode of care, an average of 4 weeks
|
Modified Clinical Test of Sensory Integration and Balance
Time Frame: before intensive therapy episode of care, an average of 4 weeks
|
mCISIB--balance test in 4 conditions
|
before intensive therapy episode of care, an average of 4 weeks
|
Pediatric Balance Scale
Time Frame: before intensive therapy episode of care, an average of 4 weeks
|
PBS-balance test
|
before intensive therapy episode of care, an average of 4 weeks
|
Pediatric Balance Scale
Time Frame: after intensive therapy episode of care, an average of 4 weeks
|
PBS-balance test
|
after intensive therapy episode of care, an average of 4 weeks
|
Functional Gait Assessment (FGA)
Time Frame: before intensive therapy episode of care, an average of 4 weeks
|
Assesses functional gait performance
|
before intensive therapy episode of care, an average of 4 weeks
|
Functional Gait Assessment (FGA)
Time Frame: after intensive therapy episode of care, an average of 4 weeks
|
Assesses functional gait performance
|
after intensive therapy episode of care, an average of 4 weeks
|
Segmental Assessment of Trunk Control (SATCo)
Time Frame: before intensive therapy episode of care, an average of 4 weeks
|
Assessment of trunk control
|
before intensive therapy episode of care, an average of 4 weeks
|
Segmental Assessment of Trunk Control (SATCo)
Time Frame: after intensive therapy episode of care, an average of 4 weeks
|
Assessment of trunk control
|
after intensive therapy episode of care, an average of 4 weeks
|
Survey
Time Frame: after intensive therapy episode of care, an average of 4 weeks
|
4 open-ended questions about caregiver/child experience with intensive therapy program
|
after intensive therapy episode of care, an average of 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2022
Primary Completion (Actual)
September 1, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
May 18, 2022
First Submitted That Met QC Criteria
June 29, 2022
First Posted (Actual)
July 5, 2022
Study Record Updates
Last Update Posted (Actual)
March 24, 2023
Last Update Submitted That Met QC Criteria
March 22, 2023
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2090791
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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