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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05443763
Other study ID # 2090791
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 23, 2022
Est. completion date September 1, 2022

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
An interdisciplinary intensive therapy program
Children will receive physical, occupation, and/or speech therapy 1-3 hours/day each for 4-5 days/week x 4 weeks.

Locations

Country Name City State
United States Children's Therapy Center--MU Healthcare 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 Instrumented Gait Analysis 3D gait analysis in gait lab before intensive therapy episode of care, approximately 4 weeks
Primary Instrumented Gait Analysis 3D gait analysis in gait lab after intensive therapy episode of care, approximately 4 weeks
Primary Center of pressure measure COP measure during balance task after intensive therapy episode of care, approximately 4 weeks
Primary Center of pressure measure COP measure during balance task before intensive therapy episode of care, approximately 4 weeks
Primary Measures of processes of care (MOPC) Questionnaire to assess satisfaction with therapy services after intensive therapy episode of care, an average of 4 weeks
Primary Timed up and go 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
Primary Timed up and go 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
Primary Modified Clinical Test of Sensory Integration and Balance mCISIB--balance test in 4 conditions after intensive therapy episode of care, an average of 4 weeks
Primary Modified Clinical Test of Sensory Integration and Balance mCISIB--balance test in 4 conditions before intensive therapy episode of care, an average of 4 weeks
Primary Pediatric Balance Scale PBS-balance test before intensive therapy episode of care, an average of 4 weeks
Primary Pediatric Balance Scale PBS-balance test after intensive therapy episode of care, an average of 4 weeks
Primary Functional Gait Assessment (FGA) Assesses functional gait performance before intensive therapy episode of care, an average of 4 weeks
Primary Functional Gait Assessment (FGA) Assesses functional gait performance after intensive therapy episode of care, an average of 4 weeks
Primary Segmental Assessment of Trunk Control (SATCo) Assessment of trunk control before intensive therapy episode of care, an average of 4 weeks
Primary Segmental Assessment of Trunk Control (SATCo) Assessment of trunk control after intensive therapy episode of care, an average of 4 weeks
Primary Survey 4 open-ended questions about caregiver/child experience with intensive therapy program after intensive therapy episode of care, an average of 4 weeks
See also
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