Evaluating the Foot Touch Framework Model

NCT04699019 | Completed

• 1 other identifier: 20190314
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Barefoot Running

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Ground reaction force

  Assessed on day 1 (data collection day)

• Ankle joint angle

  Assessed on day 1 (data collection day)

• Knee joint angle

  Assessed on day 1 (data collection day)

• Hip joint angle

  Assessed on day 1 (data collection day)

Study Arms (1)

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; Other: Foot Strike Pattern

Interventions

Four speeds OTHER

Four speeds ranging from a set walking speed up to 9 mph

Active Runners

Foot Strike Pattern OTHER

Foot strike sequences (rearfoot strike, midfoot strike, forefoot strike)

Active Runners

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Orthocare Innovations, LLC: lead
• FastEquation Inc.: collaborator

Study Sites (1)

Orthocare Innovations, LLC

Edmonds, Washington, 98020, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 7, 2021
• Study Start: February 7, 2019
• Primary Completion: July 28, 2019
• Study Completion: January 8, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)