Clinical Trials Directory

Trials / Completed

CompletedNCT02018380

Effects of Shock Absorbing Insoles on Knee Pain and Walking in Persons With Knee Osteoarthritis

Immediate Effects of Shock Absorbing Insoles on Knee Pain, Functional Mobility, and Lower Extremity Biomechanical Characteristics in Persons With Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Winston Salem State University · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

Summary

Osteoarthritis (OA) is a progressive, chronic disease affecting more than 20 million Americans. There is no known cure for OA and management includes pain control and prevention of functional decline. Purpose: To investigate the immediate effects of a shock absorbing insole (SAI) placed in the shoe on knee pain, functional mobility and lower extremity biomechanics.

Detailed description

Sixty adults (age 50+) with knee OA and pain will be recruited. A physician will diagnose the severity of knee OA through radiographs. Participants will be tested in the KBR Human Performance Lab on the campus of Winston Salem State University (WSSU). Participants will complete a demographic form and a survey about their knee pain and function. Participants will be evaluated under two conditions: 1) with SAI placed inside the shoe and 2) shoes alone. There are three walking tasks: 1) walking 25 feet at their usual pace; 2) walking 25 feet at a fast pace; 3) walking six minutes for distance; and a 4) biomechanical gait analysis. After each of the walks, participants will rate the amount of knee pain they experienced. During the biomechanical analysis, participants will walk down a 20 foot walkway while wearing reflective markers. Eight cameras and a force plate embedded in the walkway will measure the amount of body movement and the forces applied to the leg joints during walking.

Conditions

Interventions

TypeNameDescription
OTHERShock Absorbing Insole (SofSole Athletes Plus)The shock absorbing insole used in this study was the SofSole Athletes Plus, (Implus Inc, Durham, NC), recommended by the manufacturer for repetitive activities such as running and walking. It is readily available in most athletic shoe stores, retailing for under $20.00. The insole is full-length with a curved last made of Implus XP that has a shore A durometer reading of 60 (0 = softest to 100 = hardest).

Timeline

Start date
2006-08-01
Primary completion
2008-05-01
Completion
2008-07-01
First posted
2013-12-23
Last updated
2013-12-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02018380. Inclusion in this directory is not an endorsement.