Individualized Assessment of Motor Function and Balance in Intensive Therapy

August 28, 2023 updated by: Jamie Hall, University of Missouri-Columbia

Individualized Use of a Multi-dimensional Instrumented Assessment of Motor Function and Balance Following an Intensive Therapy Episode of Care

The goal of this study is to assess the individualized use of technology to assess motor function and balance for ambulatory children participating in an intensive therapy episode of care and determine the effectiveness of the program. Children 7-17 years old who can walk and are completing an intensive therapy episode of care will be recruited to participate in this study. Demographic, health history, and PT,OT,ST medical records will be collected. Based on the participant's functional goals, motor function and balance tests will be selected including common balance tests (standing with eyes open, standing with eyes closed), walking, walking and turning, standing up and sitting down from a bench, reaction time, and step down. Participants will be tested before, immediately after, 6 weeks after, and 12 weeks after the episode of care.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to assess the individualized use of instrumented assessment of motor function and balance for ambulatory children participating in an intensive therapy episode of care and determine the effectiveness of the intervention. Children 7-17 with neurodevelopmental diagnosis, GMFCS Levels I and II and completing an intensive therapy episode of care will be recruited to participate in this study. Demographic, health history, and PT,OT,ST medical records will be collected. Based on the participant's functional goals, motor function and balance tests in single and dual conditions will be selected including Romberg balance tests, walking, walking and turning, sit to/from stand, reaction time, and step down administered while participant is recorded using a portable measurement platform which incorporates a custom force plate, Azure Kinect spatial sensor, and interface board. Participants will be tested before, immediately after, 6 weeks after, and 12 weeks after the episode of care. Testing is estimated to last for 45 minutes.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • 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

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Ambulatory children aged 7-17 years old receiving care in an interdisciplinary intensive therapy program.

Description

Inclusion Criteria:

  • Ambulatory children 7-17 years old receiving care in an interdisciplinary, intensive therapy program
  • GMFCS Levels I and II
  • able to follow 2-3 step directions
  • English speaking

Exclusion Criteria:

  • orthopedic surgery in the past year or
  • significant visual impairment
  • significant hearing impairment.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eyes closed standing on firm surface
Time Frame: before physical therapy begins
center of pressure as a measure of postural control obtained from a forceplate obtained while eyes closed standing on firm surface
before physical therapy begins
Eyes closed standing on firm surface
Time Frame: immediately following physical therapy
center of pressure as a measure of postural control obtained from a forceplate obtained while eyes closed standing on firm surface
immediately following physical therapy
Eyes closed standing on firm surface
Time Frame: 6 weeks following physical therapy
center of pressure as a measure of postural control obtained from a forceplate obtained while eyes closed standing on firm surface
6 weeks following physical therapy
Eyes closed standing on firm surface
Time Frame: 12 weeks following physical therapy
center of pressure as a measure of postural control obtained from a forceplate obtained while eyes closed standing on firm surface
12 weeks following physical therapy
Eyes closed standing on firm surface
Time Frame: before physical therapy
joint kinematics (movement strategies) obtained while eyes closed standing on firm surface
before physical therapy
Eyes closed standing on firm surface
Time Frame: immediately following physical therapy
joint kinematics (movement strategies) obtained while eyes closed standing on firm surface
immediately following physical therapy
Eyes closed standing on firm surface
Time Frame: 6 weeks following physical therapy
joint kinematics (movement strategies) obtained while eyes closed standing on firm surface
6 weeks following physical therapy
Eyes closed standing on firm surface
Time Frame: 12 weeks following physical therapy
joint kinematics (movement strategies) obtained while eyes closed standing on firm surface
12 weeks following physical therapy
Walking
Time Frame: before physical therapy
speed obtained from spatial sensor
before physical therapy
Walking
Time Frame: immediately following physical therapy
speed obtained from spatial sensor
immediately following physical therapy
Walking
Time Frame: 6 weeks following physical therapy
speed obtained from spatial sensor
6 weeks following physical therapy
Walking
Time Frame: 12 weeks following
speed obtained from spatial sensor
12 weeks following
Walking
Time Frame: before physical therapy
stride length obtained from spatial sensor
before physical therapy
Walking
Time Frame: immediately following physical therapy
stride length obtained from spatial sensor
immediately following physical therapy
Walking
Time Frame: 6 weeks following physical therapy
stride length obtained from spatial sensor
6 weeks following physical therapy
Walking
Time Frame: 12 weeks following physical therapy
stride length obtained from spatial sensor
12 weeks following physical therapy
5 Times sit to stand test
Time Frame: before physical therapy
time to complete obtained from spatial sensor
before physical therapy
5 Times sit to stand test
Time Frame: immediately following physical therapy
time to complete obtained from spatial sensor
immediately following physical therapy
5 Times sit to stand test
Time Frame: 6 weeks following physical therapy
time to complete obtained from spatial sensor
6 weeks following physical therapy
5 Times sit to stand test
Time Frame: 12 weeks following physical therapy
time to complete obtained from spatial sensor
12 weeks following physical therapy
5 Times sit to stand test
Time Frame: before physical therapy
knee joint kinematics obtained from spatial sensor
before physical therapy
5 Times sit to stand test
Time Frame: immediately following physical therapy
knee joint kinematics obtained from spatial sensor
immediately following physical therapy
5 Times sit to stand test
Time Frame: 6 weeks following physical therapy
knee joint kinematics obtained from spatial sensor
6 weeks following physical therapy
5 Times sit to stand test
Time Frame: 12 weeks following physical therapy
knee joint kinematics obtained from spatial sensor
12 weeks following physical therapy
Step down
Time Frame: before physical therapy
knee joint kinematics obtained from spatial sensor
before physical therapy
Step down
Time Frame: immediately following physical therapy
knee joint kinematics obtained from spatial sensor
immediately following physical therapy
Step down
Time Frame: 6 weeks following physical therapy
knee joint kinematics obtained from spatial sensor
6 weeks following physical therapy
Step down
Time Frame: 12 weeks following physical therapy
knee joint kinematics obtained from spatial sensor
12 weeks following physical therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measures of processes of care
Time Frame: immediately following the episode of care
Questionnaire designed to assess parents' perceptions of the care they and their children receive from children's rehabilitation treatment centres. It is a means to assess family-centred behaviours of health care providers.
immediately following the episode of care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 22, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2096274

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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