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

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

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.

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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