- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00506714
Walking Aids in the Management of Hip Osteoarthritis
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90073
- VA West Los Angeles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adult subjects with hip osteoarthritis
Walk with and without a single point cane at baseline and after four weeks
|
Adjustable single point cane with SureGrip handle
|
|
No Intervention: Healthy Subjects
Healthy adults walking without a cane at baseline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gait Velocity
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait Velocity With a Cane in Hip OA Subjects
Time Frame: Baseline
|
Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.
|
Baseline
|
|
Gait Velocity
Time Frame: 4 weeks
|
Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Meika A Fang, MD, VA Greater Los Angeles Healthcare System Department of Medicine; UCLA Department of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-030430
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