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Walking Aids in the Management of Knee Osteoarthritis

Primary Purpose

Obesity, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single point cane
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Cane, Gait, Obesity, Osteoarthritis, Walking Aids

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Greater Los Angeles Healthcare System, West LA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Single point cane

No cane

Arm Description

People with knee osteoarthritis underwent gait analysis with a cane

Patients with knee osteoarthritis undergo gait analysis without a cane

Outcomes

Primary Outcome Measures

Peak Vertical Force on Affected Limb
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).

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
September 29, 2017
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00223795
Brief Title
Walking Aids in the Management of Knee Osteoarthritis
Official Title
Walking Aids in the Management of Obesity-Related Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Osteoarthritis
Keywords
Cane, Gait, Obesity, Osteoarthritis, Walking Aids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single point cane
Arm Type
Active Comparator
Arm Description
People with knee osteoarthritis underwent gait analysis with a cane
Arm Title
No cane
Arm Type
No Intervention
Arm Description
Patients with knee osteoarthritis undergo gait analysis without a cane
Intervention Type
Device
Intervention Name(s)
Single point cane
Other Intervention Name(s)
Guardian offset handled cane with sure grip
Intervention Description
Participants with symptomatic knee osteoarthritis will undergo gait evaluation with and without a single point cane.
Primary Outcome Measure Information:
Title
Peak Vertical Force on Affected Limb
Description
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).
Time Frame
Baseline and end of first intervention period (2 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meika Fang, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West LA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West LA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25305371
Citation
Fang MA, Heiney C, Yentes JM, Harada ND, Masih S, Perell-Gerson KL. Effects of contralateral versus ipsilateral cane use on gait in people with knee osteoarthritis. PM R. 2015 Apr;7(4):400-6. doi: 10.1016/j.pmrj.2014.09.018. Epub 2014 Oct 8.
Results Reference
derived
PubMed Identifier
24933725
Citation
Harada N, Fong S, Heiney C, Yentes JM, Perell-Gerson KL, Fang MA. Evaluation of two cane instruments in older adults with knee osteoarthritis. J Rehabil Res Dev. 2014;51(2):275-83. doi: 10.1682/JRRD.2013.06.0140.
Results Reference
derived

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Walking Aids in the Management of Knee Osteoarthritis

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