Effects of Shock Absorbing Insoles on Knee Pain and Walki... | NCT02018380

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

NCT02018380

Sponsor

Winston Salem State University

Status

Completed

Last Update Posted

Dec 23, 2013Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Osteoarthritis

Interventions

Shock Absorbing Insole (SofSole Athletes Plus)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

May 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Jun 29, 2009

First Submission Date that Met QC Criteria

Dec 16, 2013

First Posted Date

Dec 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2013

Last Update Posted Date

Dec 23, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Judy L. Foxworth, PT, PhD, OCS, Associate Professor, Winston Salem State UniversityPrincipal Investigator

Lead Sponsor

Winston Salem State UniversityOTHER

Collaborators

Name	Class
Wake Forest University Health Sciences	OTHER
University of North Carolina	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shock Absorbing Insoles vs. Athletic shoes	Experimental		Other: Shock Absorbing Insole (SofSole Athletes Plus)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Shock Absorbing Insole (SofSole Athletes Plus)	Other	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee pain while walking		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Ground Reaction Forces		Baseline
Knee joint kinetics during stance phase of gait		Baseline
Gait speed

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Judy L Foxworth, PT, PhD	Winston Salem State University	Principal Investigator
Darin Padua, ATC, PhD	Unversity of North Carolina	Study Chair
Stephen Messier, PhD	Wake Forest University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Winston Salem State University		Winston-Salem	North Carolina	27110	United States

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

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Browse Branches

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