Pediatric Normative Movement Analysis Data Collection

• Sponsor: MultiCare Health System Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04638595
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric ALL	Other: Observation

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Pediatric Normative Movement Analysis Data Collection
• Actual Study Start Date: Nov 16, 2020
• Actual Primary Completion Date: May 5, 2021
• Actual Study Completion Date: May 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Normative 50 neurotypical pediatric subjects	Other: Observation; 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.

Outcome Measures

Primary Outcome Measures

1. Create normative baseline data for typically developing children [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mary Bridge Children's Therapy Unit	Puyallup	Washington	United States	98372

Sponsors and Collaborators

• MultiCare Health System Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MultiCare Health System Research Institute
• ClinicalTrials.gov Identifier: NCT04638595
• Other Study ID Numbers: Normative Data Study
• First Posted: Nov 20, 2020
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 5, 2022