NCT04638595

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2021

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

November 16, 2020

Last Update Submit

August 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Create normative baseline data for typically developing children

    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

Study Arms (1)

Normative

50 neurotypical pediatric subjects

Other: Observation

Interventions

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.

Normative

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mary Bridge Children's Therapy Unit

Puyallup, Washington, 98372, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Observation

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 20, 2020

Study Start

November 16, 2020

Primary Completion

May 5, 2021

Study Completion

May 5, 2021

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations