ObesityNCT00223795
Walking Aids in the Management of Knee Osteoarthritis
A study testing Single point cane in people with Obesity and Osteoarthritis, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Obesity, Osteoarthritis
- What is being tested?
- Single point cane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Oct 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
About this study
Official title: Walking Aids in the Management of Obesity-Related Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Obesity, Osteoarthritis
- Being tested
- Single point cane
- Keywords
- Cane, Gait, Obesity, Osteoarthritis, Walking Aids
- Medical subject headings
- Obesity, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single point caneDevice
Also called Guardian offset handled cane with sure grip
Participants with symptomatic knee osteoarthritis will undergo gait evaluation with and without a single point cane.
| Study group | Role | What they receive |
|---|---|---|
| Single point cane | Active comparator | People with knee osteoarthritis underwent gait analysis with a cane Receives: Device: Single point cane |
| No cane | No intervention | Patients with knee osteoarthritis undergo gait analysis without a cane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and end of first intervention period (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2006
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Meika Fang, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223795
- Sponsor's protocol ID
- F3873-R
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2005
- Last updated
- 1 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25305371Harada 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.
PubMed 24933725
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Aids in the Management of Obesity-Related Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00223795
- Acronym / sponsor ID
- F3873-R
- Conditions
- Obesity, Osteoarthritis
- Keywords
- Cane, Gait, Obesity, Osteoarthritis, Walking Aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jul 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 22 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single point cane | Active comparator | Device: Single point canePeople with knee osteoarthritis underwent gait analysis with a cane |
| No cane | No intervention | –Patients with knee osteoarthritis undergo gait analysis without a cane |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single point caneAlso: Guardian offset handled cane with sure gripParticipants with symptomatic knee osteoarthritis will undergo gait evaluation with and without a single point cane. | Device | Single point cane |
Primary outcome
Peak Vertical Force on Affected Limb
Time frame: Baseline and end of first intervention period (2 months)
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25305371Fang 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.
- Derived from this study: PubMed 24933725Harada 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meika Fang, MD principal investigator
VA Greater Los Angeles Healthcare System, West LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single point cane in people with Obesity and Osteoarthritis, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Vertical Force on Affected Limb (time frame: Baseline and end of first intervention period (2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00223795, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.