NCT05443763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 24, 2023

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

May 18, 2022

Last Update Submit

March 22, 2023

Conditions

Outcome Measures

Primary Outcomes (16)

  • Instrumented Gait Analysis

    3D gait analysis in gait lab

    before intensive therapy episode of care, approximately 4 weeks

  • Instrumented Gait Analysis

    3D gait analysis in gait lab

    after intensive therapy episode of care, approximately 4 weeks

  • Center of pressure measure

    COP measure during balance task

    after intensive therapy episode of care, approximately 4 weeks

  • Center of pressure measure

    COP measure during balance task

    before intensive therapy episode of care, approximately 4 weeks

  • Measures of processes of care (MOPC)

    Questionnaire to assess satisfaction with therapy services

    after intensive therapy episode of care, an average of 4 weeks

  • 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

  • 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

  • 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

  • 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

  • Pediatric Balance Scale

    PBS-balance test

    before intensive therapy episode of care, an average of 4 weeks

  • Pediatric Balance Scale

    PBS-balance test

    after intensive therapy episode of care, an average of 4 weeks

  • Functional Gait Assessment (FGA)

    Assesses functional gait performance

    before intensive therapy episode of care, an average of 4 weeks

  • Functional Gait Assessment (FGA)

    Assesses functional gait performance

    after intensive therapy episode of care, an average of 4 weeks

  • Segmental Assessment of Trunk Control (SATCo)

    Assessment of trunk control

    before intensive therapy episode of care, an average of 4 weeks

  • Segmental Assessment of Trunk Control (SATCo)

    Assessment of trunk control

    after intensive therapy episode of care, an average of 4 weeks

  • Survey

    4 open-ended questions about caregiver/child experience with intensive therapy program

    after intensive therapy episode of care, an average of 4 weeks

Interventions

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

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children receiving therapy through Children's Therapy Center's Tiger Intensive Program and their caregivers from May 23, 2022, to Aug 19, 2022.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Therapy Center--MU Healthcare

Columbia, Missouri, 65201, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cohort study of children receiving intensive therapy and their caregivers
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Teaching Professor

Study Record Dates

First Submitted

May 18, 2022

First Posted

July 5, 2022

Study Start

May 23, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

March 24, 2023

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations