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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings