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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Shock Absorbing Insole (SofSole Athletes Plus)
Sponsored by
Winston Salem State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 50 years of age or older
  • Radiographic evidence of knee OA in the test extremity (K-L grading scale = 1 to 4)
  • Knee pain (WOMAC pain subscore of 4 or more and report moderate pain on at least 1 listed activity in the WOMAC) on most days
  • Able to speak, write, and understand English
  • Able to walk 25 feet without an assistive device
  • Must wear a shoe size available in the lab (Women's 6-10 and Men's 8-14)
  • Able to attend two sessions of data collection within 14 days

Exclusion Criteria:

  • Currently wearing some type of foot orthosis (custom or over-the counter)
  • Had lower extremity surgery of the test leg in the past 12 months
  • Had a total knee replacement on the involved leg
  • Had hip and/or ankle OA in the involved leg
  • Had a neuromuscular disease disorder which affected their walking ability

Sites / Locations

  • Winston Salem State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shock Absorbing Insoles vs. Athletic shoes

Arm Description

Outcomes

Primary Outcome Measures

Knee pain while walking

Secondary Outcome Measures

Ground Reaction Forces
Knee joint kinetics during stance phase of gait
Gait speed

Full Information

First Posted
June 29, 2009
Last Updated
December 16, 2013
Sponsor
Winston Salem State University
Collaborators
Wake Forest University Health Sciences, University of North Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02018380
Brief Title
Effects of Shock Absorbing Insoles on Knee Pain and Walking in Persons With Knee Osteoarthritis
Official Title
Immediate Effects of Shock Absorbing Insoles on Knee Pain, Functional Mobility, and Lower Extremity Biomechanical Characteristics in Persons With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Winston Salem State University
Collaborators
Wake Forest University Health Sciences, University of North Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shock Absorbing Insoles vs. Athletic shoes
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Shock Absorbing Insole (SofSole Athletes Plus)
Other Intervention Name(s)
SofSole Athletes Plus
Intervention Description
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).
Primary Outcome Measure Information:
Title
Knee pain while walking
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Ground Reaction Forces
Time Frame
Baseline
Title
Knee joint kinetics during stance phase of gait
Time Frame
Baseline
Title
Gait speed
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50 years of age or older Radiographic evidence of knee OA in the test extremity (K-L grading scale = 1 to 4) Knee pain (WOMAC pain subscore of 4 or more and report moderate pain on at least 1 listed activity in the WOMAC) on most days Able to speak, write, and understand English Able to walk 25 feet without an assistive device Must wear a shoe size available in the lab (Women's 6-10 and Men's 8-14) Able to attend two sessions of data collection within 14 days Exclusion Criteria: Currently wearing some type of foot orthosis (custom or over-the counter) Had lower extremity surgery of the test leg in the past 12 months Had a total knee replacement on the involved leg Had hip and/or ankle OA in the involved leg Had a neuromuscular disease disorder which affected their walking ability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy L Foxworth, PT, PhD
Organizational Affiliation
Winston Salem State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darin Padua, ATC, PhD
Organizational Affiliation
Unversity of North Carolina
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stephen Messier, PhD
Organizational Affiliation
Wake Forest University
Official's Role
Study Director
Facility Information:
Facility Name
Winston Salem State University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27110
Country
United States

12. IPD Sharing Statement

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

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