Evaluating the Foot Touch Framework Model

Barefoot Running Clinical Trial

Official title:

Evaluating the Foot Touch Framework Model in Running

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699019
• Other study ID #: 20190314
• Status: Completed
• Start date: February 7, 2019
• Est. completion date: January 8, 2021

Study information

• Verified date: September 2021
• Source: Orthocare Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 8, 2021
• Est. primary completion date: July 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Barefoot Running

Intervention

Other:
• Four speeds
Four speeds ranging from a set walking speed up to 9 mph
• Foot Strike Pattern
Foot strike sequences (rearfoot strike, midfoot strike, forefoot strike)

Locations

Country	Name	City	State
United States	Orthocare Innovations, LLC	Edmonds	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Orthocare Innovations, LLC	FastEquation Inc.

Country where clinical trial is conducted

United States, 

Outcome

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