Walking Aids in the Management of Knee Osteoarthritis

NCT00223795 | Completed Results

• 1 other identifier: F3873-R
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Osteoarthritis

Keywords

Cane; Gait; Obesity; Osteoarthritis; Walking Aids

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and end of first intervention period (2 months)

Study Arms (2)

Single point cane

ACTIVE COMPARATOR

People with knee osteoarthritis underwent gait analysis with a cane

Device: Single point cane

No cane

NO INTERVENTION

Patients with knee osteoarthritis undergo gait analysis without a cane

Interventions

Single point cane DEVICE

Participants with symptomatic knee osteoarthritis will undergo gait evaluation with and without a single point cane.

Also known as: Guardian offset handled cane with sure grip

Single point cane

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

Related Publications (2)

• 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.

  PMID: 25305371 DERIVED

• 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.

  PMID: 24933725 DERIVED

MeSH Terms

Conditions

Obesity; Osteoarthritis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Had high drop out rate leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Meika A. Fang, MD
• Organization: VA Greater Los Angeles Healthcare System

meika.fang@va.gov

310-268-4503

Study Officials

• Meika Fang, MD

  VA Greater Los Angeles Healthcare System, West LA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 1, 2017
• Results First Posted: April 22, 2014

Record last verified: 2017-09

Locations

US (1)