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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single point cane | Active Comparator | People with knee osteoarthritis underwent gait analysis with a cane |
|
| No cane | No Intervention | Patients with knee osteoarthritis undergo gait analysis without a cane |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single point cane | Device | Participants with symptomatic knee osteoarthritis will undergo gait evaluation with and without a single point cane. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meika Fang, MD | VA Greater Los Angeles Healthcare System, West LA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West LA | West Los Angeles | California | 90073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25305371 | Derived | 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. | |
| 24933725 | 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. |
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Subjects were recruited 2005-2008from the outpatient clinics of the VA West Los Angeles Healthcare Center, an urban tertiary academic hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 - Control/Crossover | No cane first, then single point cane |
| FG001 | Arm 2 - Cane | Single point cane first, then continue with single point cane |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention - Eight Weeks |
|
| ||||||||||||||||||
| Second Intervention - All Use Canes 4 mo |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Characteristics All Subjects | Community-dwelling patients with unilateral knee pain on movement which they scored at >35 mm on a 100-mm visual analogue scale (VAS) for most days of the previous month. Other inclusion criteria included having a weight less than 300 pounds, no cane use for the past 30 days, fulfillment of the American College of Rheumatology criteria for knee OA , and radiographic Kellgren-Lawrence scale knee OA grade > 1. We excluded individuals who had knee trauma or surgery, including arthroscopic surgery, within the past six months, upper body weakness, injury or amputation to the lower extremity joints, symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee, poor health that would impair compliance or assessment such as shortness of breath with exertion, or neurological disease including vestibular dysfunction, or impaired vision. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | N/kg | Baseline and end of first intervention period (2 months) |
|
Adverse event data was collected over a 6 month period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Intervention - no Cane for First 8 Weeks | No cane for first 8 weeks |
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Had high drop out rate leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meika A. Fang, MD | VA Greater Los Angeles Healthcare System | 310-268-4503 | meika.fang@va.gov |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Arm 2- Cane Users | Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants given a cane to use at home during the first intervention period and then for four months after the first intervention period. |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Arm 1 - Intervention - Crossover to Cane | Given single point cane to use for 4 months following 8 weeks without a cane | 0 | 26 | 0 | 26 |
| EG002 | Arm 2- Single Point Cane | single point cane for 8 weeks then single point cane for next 4 months | 0 | 27 | 0 | 27 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |