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Exploring the Experiences and Outcomes of a Summer Intensive Therapy Program- Mixed Methods Study

Primary Purpose

Children With Neurodevelopmental Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
An interdisciplinary intensive therapy program
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children With Neurodevelopmental Disorders

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Therapy Center--MU Healthcare

Outcomes

Primary Outcome Measures

Instrumented Gait Analysis
3D gait analysis in gait lab
Instrumented Gait Analysis
3D gait analysis in gait lab
Center of pressure measure
COP measure during balance task
Center of pressure measure
COP measure during balance task
Measures of processes of care (MOPC)
Questionnaire to assess satisfaction with therapy services
Timed up and go
TUG assessment--timed assessment including standing from a chair, walking a distance and returning to the chair
Timed up and go
TUG assessment--timed assessment including standing from a chair, walking a distance and returning to the chair
Modified Clinical Test of Sensory Integration and Balance
mCISIB--balance test in 4 conditions
Modified Clinical Test of Sensory Integration and Balance
mCISIB--balance test in 4 conditions
Pediatric Balance Scale
PBS-balance test
Pediatric Balance Scale
PBS-balance test
Functional Gait Assessment (FGA)
Assesses functional gait performance
Functional Gait Assessment (FGA)
Assesses functional gait performance
Segmental Assessment of Trunk Control (SATCo)
Assessment of trunk control
Segmental Assessment of Trunk Control (SATCo)
Assessment of trunk control
Survey
4 open-ended questions about caregiver/child experience with intensive therapy program

Secondary Outcome Measures

Full Information

First Posted
May 18, 2022
Last Updated
March 22, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05443763
Brief Title
Exploring the Experiences and Outcomes of a Summer Intensive Therapy Program- Mixed Methods Study
Official Title
Exploring the Experiences and Outcomes of a Summer Intensive Therapy Program- Mixed Methods Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children With Neurodevelopmental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort study of children receiving intensive therapy and their caregivers
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
An interdisciplinary intensive therapy program
Intervention Description
Children will receive physical, occupation, and/or speech therapy 1-3 hours/day each for 4-5 days/week x 4 weeks.
Primary Outcome Measure Information:
Title
Instrumented Gait Analysis
Description
3D gait analysis in gait lab
Time Frame
before intensive therapy episode of care, approximately 4 weeks
Title
Instrumented Gait Analysis
Description
3D gait analysis in gait lab
Time Frame
after intensive therapy episode of care, approximately 4 weeks
Title
Center of pressure measure
Description
COP measure during balance task
Time Frame
after intensive therapy episode of care, approximately 4 weeks
Title
Center of pressure measure
Description
COP measure during balance task
Time Frame
before intensive therapy episode of care, approximately 4 weeks
Title
Measures of processes of care (MOPC)
Description
Questionnaire to assess satisfaction with therapy services
Time Frame
after intensive therapy episode of care, an average of 4 weeks
Title
Timed up and go
Description
TUG assessment--timed assessment including standing from a chair, walking a distance and returning to the chair
Time Frame
before intensive therapy episode of care, an average of 4 weeks
Title
Timed up and go
Description
TUG assessment--timed assessment including standing from a chair, walking a distance and returning to the chair
Time Frame
fter intensive therapy episode of care, an average of 4 weeks
Title
Modified Clinical Test of Sensory Integration and Balance
Description
mCISIB--balance test in 4 conditions
Time Frame
after intensive therapy episode of care, an average of 4 weeks
Title
Modified Clinical Test of Sensory Integration and Balance
Description
mCISIB--balance test in 4 conditions
Time Frame
before intensive therapy episode of care, an average of 4 weeks
Title
Pediatric Balance Scale
Description
PBS-balance test
Time Frame
before intensive therapy episode of care, an average of 4 weeks
Title
Pediatric Balance Scale
Description
PBS-balance test
Time Frame
after intensive therapy episode of care, an average of 4 weeks
Title
Functional Gait Assessment (FGA)
Description
Assesses functional gait performance
Time Frame
before intensive therapy episode of care, an average of 4 weeks
Title
Functional Gait Assessment (FGA)
Description
Assesses functional gait performance
Time Frame
after intensive therapy episode of care, an average of 4 weeks
Title
Segmental Assessment of Trunk Control (SATCo)
Description
Assessment of trunk control
Time Frame
before intensive therapy episode of care, an average of 4 weeks
Title
Segmental Assessment of Trunk Control (SATCo)
Description
Assessment of trunk control
Time Frame
after intensive therapy episode of care, an average of 4 weeks
Title
Survey
Description
4 open-ended questions about caregiver/child experience with intensive therapy program
Time Frame
after intensive therapy episode of care, an average of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Children's Therapy Center--MU Healthcare
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exploring the Experiences and Outcomes of a Summer Intensive Therapy Program- Mixed Methods Study

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