Evaluating the Foot Touch Framework Model

Evaluating the Foot Touch Framework Model in Running

A Foot Touch framework model has been developed to express the ground reaction force waveforms observed for walking and running. The purpose of this research is to collect ground reaction force data during walking and running that can be used to evaluate and verify the Foot Touch framework.

Study Overview

• Status: Completed
• Conditions: Barefoot Running
• Intervention / Treatment: Other: Four speeds; Other: Foot Strike Pattern

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Washington
    • Edmonds, Washington, United States, 98020
      • Orthocare Innovations, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy, able-bodied participants will be recruited from the general public.

Description

Inclusion Criteria:

• Healthy adult men and women
• Capable of independently walking and running at various speeds for a minimum of 30 minutes
• No history of significant injuries in the past six months
• Ability to walk and run without shoes/footwear
• Ability to perform one- and two-footed hops up and down from 5 cm and 10 cm heights
• Ability to provide informed consent

Exclusion Criteria:

• Confounding chronic injury or musculoskeletal problem
• Pregnancy
• Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
• Not able to read and understand English

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active Runners; All participants will be required to run unshod for a combination of four prescribed speeds (walking and up to 9 mph) and three different foot strike patterns (rearfoot, midfoot, and forefoot) on level ground.	Other: Four speeds; Four speeds ranging from a set walking speed up to 9 mph; Other: Foot Strike Pattern; Foot strike sequences (rearfoot strike, midfoot strike, forefoot strike)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MatScan Forces	Ground reaction forces for distinct anatomical regions of the foot (Calcaneal, Tarsal, Metatarsal, Phalangeal) measured by the MatScan system	Assessed on day 1 (data collection day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ground reaction force	Ground reaction force measured by the force plate during walking, running, and hopping tasks	Assessed on day 1 (data collection day)
Ankle joint angle	Ankle joint angle measured by motion analysis system during walking, running, and hopping tasks	Assessed on day 1 (data collection day)
Knee joint angle	Knee joint angle measured by motion analysis system during walking, running, and hopping tasks	Assessed on day 1 (data collection day)
Hip joint angle	Hip joint angle measured by motion analysis system during walking, running, and hopping tasks	Assessed on day 1 (data collection day)

Collaborators and Investigators

• Sponsor: Orthocare Innovations, LLC
• Collaborators: FastEquation Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 7, 2019
• Primary Completion (ACTUAL): July 28, 2019
• Study Completion (ACTUAL): January 8, 2021

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (ACTUAL): January 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 20190314

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