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Walking Aids in the Management of Hip Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
single point cane
Sponsored by
Arthritis Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Walking Sticks, Canes

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. hip OA (grades II-IV) of the Kellgren/Lawrence classification
  2. with pain in one hip for most days of the prior month
  3. Ability to walk 30 feet without postural sway
  4. Ability to stand unaided
  5. Ability to understand verbal instructions
  6. Ability to give informed consent

Exclusion Criteria:

  1. History of hip or knee trauma or surgery including arthroscopic surgery in the past six months
  2. Severe obesity (> 300 pounds)
  3. Neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy, vestibular dysfunction or poor vision
  4. Injury or amputation to the lower extremity joints
  5. History of other types of arthritis or fibromyalgia
  6. Pain from spine, knee, ankle, or foot disease that would interfere with assessment of the hip
  7. Poor health that would impair compliance or assessment such as shortness of breath with exertion, chest pain
  8. Foot deformities such as hallux rigidus, valgus deformity of the midfoot, previous ankle arthrodesis
  9. Greater trochanteric pain syndrome

Sites / Locations

  • VA West Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adult subjects with hip osteoarthritis

Healthy Subjects

Arm Description

Walk with and without a single point cane at baseline and after four weeks

Healthy adults walking without a cane at baseline

Outcomes

Primary Outcome Measures

Gait Velocity

Secondary Outcome Measures

Gait Velocity With a Cane in Hip OA Subjects
Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.
Gait Velocity
Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use

Full Information

First Posted
July 20, 2007
Last Updated
September 28, 2012
Sponsor
Arthritis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00506714
Brief Title
Walking Aids in the Management of Hip Osteoarthritis
Official Title
Walking Aids in the Management of Hip Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arthritis Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether or not the use of a nonpharmacologic intervention (single point cane) is effective in the treatment of knee osteoarthritis.
Detailed Description
Osteoarthritis (OA), the most common joint disease in humans, is a significant cause of pain and disability. Non-pharmacological treatments for hip OA include education, exercise, appliances (walking sticks or insoles), and weight reduction if obese or overweight. Canes are often recommended to reduce adverse forces across joints although there is currently no research evidence regarding the efficacy of walking sticks for hip OA. Little information is available regarding the impact of walking aids on psychosocial function and quality of life in individuals with hip OA. This study will evaluate the effects of walking aids in hip OA by examining gait biomechanics, quality of life, pain, and opinions regarding using a cane. Comparisons: Compare gait biomechanics in people with symptomatic unilateral hip OA while walking with and without a cane at baseline and after 4 weeks of cane use. Compare gait biomechanics in people with symptomatic unilateral hip OA with and without a cane to those of healthy, age-matched controls. Compare pain and health-related quality of life in people with symptomatic unilateral hip OA following 4 weeks of cane use. Determine the association between changes in gait biomechanics, pain, and health-related quality of life in people with symptomatic unilateral hip OA following 4 weeks of cane use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Walking Sticks, Canes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adult subjects with hip osteoarthritis
Arm Type
Experimental
Arm Description
Walk with and without a single point cane at baseline and after four weeks
Arm Title
Healthy Subjects
Arm Type
No Intervention
Arm Description
Healthy adults walking without a cane at baseline
Intervention Type
Device
Intervention Name(s)
single point cane
Intervention Description
Adjustable single point cane with SureGrip handle
Primary Outcome Measure Information:
Title
Gait Velocity
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Gait Velocity With a Cane in Hip OA Subjects
Description
Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.
Time Frame
Baseline
Title
Gait Velocity
Description
Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: hip OA (grades II-IV) of the Kellgren/Lawrence classification with pain in one hip for most days of the prior month Ability to walk 30 feet without postural sway Ability to stand unaided Ability to understand verbal instructions Ability to give informed consent Exclusion Criteria: History of hip or knee trauma or surgery including arthroscopic surgery in the past six months Severe obesity (> 300 pounds) Neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy, vestibular dysfunction or poor vision Injury or amputation to the lower extremity joints History of other types of arthritis or fibromyalgia Pain from spine, knee, ankle, or foot disease that would interfere with assessment of the hip Poor health that would impair compliance or assessment such as shortness of breath with exertion, chest pain Foot deformities such as hallux rigidus, valgus deformity of the midfoot, previous ankle arthrodesis Greater trochanteric pain syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meika A Fang, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System Department of Medicine; UCLA Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA West Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

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Walking Aids in the Management of Hip Osteoarthritis

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