- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04638595
Pediatric Normative Movement Analysis Data Collection
August 3, 2022 updated by: MultiCare Health System Research Institute
The objective of this project is to collect baseline data from a normative population of children that gender and age matches the population of patients expected to be treated by Mary Bridge Children's Therapy Services and seen in the Research and Movement Laboratory.
This project seeks to recruit 25 male and 25 female typically developing children between the ages of 3 and 18 years of age.
Non-invasive measurements of movement patterns will be collected during common activities of daily living over a single data collection session.
Study Overview
Study Type
Observational
Enrollment (Actual)
50
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
-
-
Washington
-
Puyallup, Washington, United States, 98372
- Mary Bridge Children's Therapy Unit
-
-
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
3 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A group of 50 neurotypical pediatric subjects will be recruited for this data collection.
Children will be assigned to 1 of 5 age groupings (3-5, 6-8, 9-11, 12-14, 15-18), with an equal amount of male/female in each.
Description
Inclusion Criteria:
- Age between 3-18 years
- Ambulate independently and without the use of assistive devices
- Perform activities of daily living without physical assistance
- Tolerate adhesive markers placed on skin and clothing
- Willing and interested in participating
Exclusion Criteria:
- Neuromuscular disorders such as cerebral palsy, muscular dystrophy, myotonic dystrophy, spinal muscular atrophy, peripheral neuropathy, or other generalized muscle and/or nerve issues
- Evidence of developmental delays, muscle weakness, decreased muscle tone, joint stiffness, muscle or bone deformity
- Currently using or has a history of using assistive technology devices, bracing/orthoses, manual or powered mobility equipment
- Was born pre-term
- Currently or has a history of taking medication or pharmaceutical treatment related to musculoskeletal side-effects/scenario/diagnosis
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Normative
50 neurotypical pediatric subjects
|
This project seeks to recruit 25 male and 25 female typically developing children between the ages of 3 and 18 years of age.
Non-invasive measurements of movement patterns will be collected during common activities of daily living over a single data collection session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Create normative baseline data for typically developing children
Time Frame: 1 year
|
Establishing a baseline of pediatric biomechanics is an important step in performing the best possible analyses for our patients.
Normative data provides that baseline, and provides the data to explore links within the dense, interconnected behavior of human motion.
|
1 year
|
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)
November 16, 2020
Primary Completion (Actual)
May 5, 2021
Study Completion (Actual)
May 5, 2021
Study Registration Dates
First Submitted
November 16, 2020
First Submitted That Met QC Criteria
November 16, 2020
First Posted (Actual)
November 20, 2020
Study Record Updates
Last Update Posted (Actual)
August 5, 2022
Last Update Submitted That Met QC Criteria
August 3, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Normative Data Study
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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