Walking Aids in the Management of Knee Osteoarthritis

September 29, 2017 updated by: VA Office of Research and Development

Walking Aids in the Management of Obesity-Related Knee Osteoarthritis

The purpose of this study is to assess whether the single point cane will relieve pain and disability in overweight or obese people with knee OA through altered joint biomechanics and what factors influence acceptance of cane use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Knee OA is an important cause of disability and falls in overweight or obese individuals and limits their attempts at exercise and subsequent weight loss. Walking aids such as canes have been recommended in the management of knee OA in order to decrease pain by reducing loading across the knee and to increase physical activity. Little information is available regarding the impact of walking aids on psychosocial function and quality of life in individuals with limited mobility. No randomized controlled trials have studied the efficacy of walking aids on quality of life, pain, and function in overweight or obese individuals with symptomatic knee OA (5,6). The proposed research will evaluate the effects of walking aids in knee OA by testing the following hypothesis that the use of a single-point cane ipsilateral and contralateral to the affected limb will decrease pain from knee OA by altering gait biomechanics and will improve walking function and quality of life in overweight or obese individuals with symptomatic knee OA.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • West Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System, West LA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 45-85 years old
  • Able to walk 30 feet without postural sway and able to stand unaided
  • Knee pain on movement with a WOMAC pain subscale of >35mm
  • Documented osteoarthritis based on clinical and radiographic criteria
  • Body Mass Index (BMI) > 25.0 - 29.9
  • Ability to understand verbal and written instructions
  • Ability to give informed consent determined by assessment of cognitive status

Exclusion Criteria:

  • Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy. History of knee trauma or surgery, including arthroscopic surgery, in the past six months
  • Severe obesity (weight > 300lbs)
  • Upper body weakness
  • Injury or amputation of the lower extremity joints
  • History of other types of arthritis
  • Spine, foot, or hip pain of sufficient magnitude to interfere with the evaluation of the index joint.
  • Isolated patellofemoral disease manifested by primarily anterior knee pain in the absence of tibiofemoral radiographic finding.
  • History of significant collateral or anterior cruciate ligament or meniscal injury to the index joint requiring at least one week of non weight bearing (minor ligamentous injury prior to 6 months is not an exclusion).
  • Poor health that would impair compliance or assessment such as shortness of breath with exertion
  • Neurological disease including vestibular dysfunction, or impaired vision
  • Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.
  • Is unable to understand and complete the study questionnaires including visual analog scale (VAS) responses.
  • Is unable to understand the study procedures.
  • Investigator feels the patient is otherwise inappropriate for the study. The patient is participating in another clinical trial that would interfere with participation in this study
  • Investigator feels the patient is otherwise inappropriate for the study.
  • The patient is participating in another clinical trial that would interfere with participation in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single point cane
People with knee osteoarthritis underwent gait analysis with a cane
Device: Single point cane
Participants with symptomatic knee osteoarthritis will undergo gait evaluation with and without a single point cane.
Other Names:
  • Guardian offset handled cane with sure grip
No Intervention: No cane
Patients with knee osteoarthritis undergo gait analysis without a cane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Vertical Force on Affected Limb
Time Frame: Baseline and end of first intervention period (2 months)
An in-shoe dynamic, pressure distribution system (Pedar-X System, Novel Electronics, Inc., St. Paul, MN) was utilized to measure the vertical ground reaction force at the baseline visit and at the end of the first intervention period (two months) gait evaluations for both the control arm and cane user arm. The control arm was not given a cane to use at home during the two month intervention period. Peak vertical force on the affected limb was measured in the laboratory setting when both control group and cane user group walked with and without a cane at baseline and at the end of the first intervention period (2 months).
Baseline and end of first intervention period (2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Meika Fang, MD, VA Greater Los Angeles Healthcare System, West LA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F3873-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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