PHI':c..lCAL THERAPY
KNEE INSTABILITY AND ADAPTATION IN MEDIAL KNEE OA
Principal Investigator: Katherine S. Rudolph PhD, PT
Charles (Buz) Swanik, PhD
Michael J. Axe, MD
PURPOSE OF RESEARCH
You are invited to participate in a research study to determine how people with knee arthritis walk compared to those without knee arthritis. Specifically, we will compare how your joints move and how your muscles turn on and off during walking and standing tasks, how stiff your knee is and how well you can feel joint motion and position. This information will be helpful in developing appropriate training and rehabilitation programs for people with knee arthritis.
This research study will include approximately 200 people (18-75 years of age) with diagnosed knee arthritis referred by local physicians and 125 uninjured people recruited from the community via flyers and advertisements. If you agree to participate, you would be scheduled for 3 separate testing sessions. These sessions would be scheduled over a few weeks at your convenience and based on the availability of the testing sites. If you have OA in both knees, we will test the knee that you tell us is worse in terms of symptoms.
1. X-rays (-30 minutes): Four x-rays will be taken of your knees by an experienced radiographer at the offices of Papa stavros' Associates or First State Orthopaedics. Papastavros Associates has offices at in
North Wilmington (3505 Silverside Rd, Suite 100, Wilmington, DE) or in Newark (2600 Glasgow Ave
#112, Newark, DE or 40 Polly Drummond Hill Rd., Newark, DE). First State Orthopaedics is located at
4745 Ogletown-Stanton Road, Newark, DE. You will be required to wear shorts for the x-rays. Due to risks associated with x-rays during pregnancy, personnel at the medical imaging offices will follow their standard procedure and ask if there is a chance that you may be pregnant. If so, you will be excluded from the study. For the first x-ray, you will be standing with your knees slightly bent and the x-ray will be taken from the back of your knees. This will be used to see if you have arthritis and to fmd out the severity. The second x-ray will be taken of your entire legs (hips, knees, and ankles) while you are standing barefoot. We will use this x-ray to measure the angle in your knees between your thigh and calf. The fmal two x-rays (called stress x-rays) will be taken to determine the looseness of your knees.
You will be lying on your back on a table with your leg in a device that will apply pressure to the inside and then to the outside of your knee while the x-ray is taken from above.
If you are a patient of Dr. Michael Axe and you have had x-rays taken at First State Orthopaedics using the procedures above in the past 3 months, we need your written permission to request a copy of the xrays. Any x-rays that we can get copies of will not be repeated.
2. Strength testing and functional assessment (1.5 hours): We will measure the strength of your quadriceps muscles (muscles in the front of your thigh that straighten your knees) in the Muscle
Performance Laboratory in the Physical Therapy Department at the University of Delaware, Room 325
McKinly Laboratory, Newark, DE 19716. You will be required to wear shorts for the strength test. For
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the strength test, you will be seated in a chair with your thigh held in place with Velcro straps and we will measure the amount of force your muscles are able to produce. Two adhesive pads will be placed on your thigh. You will be asked to "kick out" against a padded cuff as hard as you can and several practice trials will be performed. For the actual test, a short burst of electricity, lasting less than I second, will be delivered through the pads while you are kicking. During the electrical burst, you may feel a cramp in your muscles (like a "Charlie Horse"). Depending on the results, you may be asked to repeat the procedure up to 3 times.
To determine how well you are able to move you will be asked to climb up and down cone flight of stairs and you will fill out some questionnaires asking about your general health and your daily function (Knee Outcome Survey and Knee Osteoarthritis Outcome Score and International Physical Activity
Questionnaire).
3. Motion analysis testing (up to 3.5 hours): We will measure how your joints move and when your muscles turn on and off during walking and standing in the Motion Analysis Laboratory in the Physical
Therapy Department at the University of Delaware, Room 326 McKinly Laboratory, Newark DE
19716. You will be asked to wear a short sleeved shirt, loose fitting shorts and athletic shoes during testing. Four-inch wide elastic bands will be wrapped around your thighs, calves, and hips to which small balls will be attached. Additional balls will be taped to your hips, knees, ankles and sneakers with adhesive skin tape. Hypoallergenic tape or non-tape methods of attaching the equipment will be available if you are allergic to adhesive skin tape. The movement of the balls will be tracked by eight video cameras.
In order to determine when your muscles turn on and off, we will tape small sensors over the muscles in the front and back of your thigh and back of your calf with adhesive skin tape. Cables from the sensors will be attached to a small box that will be placed in a backpack that you will wear during the tests. The box helps send information about your muscles to a computer. The movements of your joints and when your muscle turns on and off will be recorded on a computer as you walk along a 30 foot walkway. In the walkway is a platform that measures the foices that your feet make when they contact the floor. c
You will be asked to do the following tests that are checked'
Number of Activity trials
10 walk Walk across a force platform that does not move
10 side-step
.
10 cuts
20 step up
50 moving
10 reflex (5 reflex trials each leg)
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Walk to a force platform that does not move. When your foot steps on the platform you will steIJ quickly to the side
Walk to a force platform that does not move. When your foot steps on the platform you will be told to pivot on your foot and continue to walk in a straight line
You will stand in front of a lO-inch high step and asked to step up and over the step. You will step up with both legs, for 10 trials each.
You will walk across a platform that will move to the side about 2 inches.
Stand with your feet shoulder width apart and one foot will be on the moveable platform and the other foot will be on a non-moveable platform. Padded straps will be wrapped around your thigh and waist to keep your hip and thigh still. The moveable platform will move about 2 inches so that you may feel a stretch on the inside part of your knee. Five trials will be completed on each leg.
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During the "50-Moving" trials you will walk along the walkway to a platform that quickly moves about
2 inches to the side when you step on it. You will be allowed to experience the moving platform with assistance of one of the testers to feel what it is like. You will be allowed to practice and to rest as often as necessary. At any time you may ask for more rest if you feel tired~
4. Joint sensation and stiffness testing (1.5 honrs): We will measure how well you feel motion and the position of your joints, and test the stiffness of your joints when yourmusc1es tum on and off. This testing will occur in the Human Performance Laboratory in the Fred Rust Arena at the University of
Delaware, Newark DE 19716.
Joint sensation Tests
To test your ability to detect knee motion and joint position sense, you will be seated in a chair with the knee of the tested leg positioned at two different starting angles. Your foot and lower leg will be placed in a splint that is attached to a motor that will bend and straighten your knee. For testing your ability to detect knee motion, you will be blindfolded for a short period of time and wear a head-set to eliminate cues from sights and sounds. This will allow you to concentrate on feelings from your knee joint. You will then be handed a switch which will turn the testing machine on and off. After you give the investigator a "thumbs up" sign showing that you are ready, the machine will begin to move your knee slowly. The moment you feel your knee moving, you will turn the machine off by pressing a switch. By pressing this off switch, you are telling the investigator that you felt your knee move. There will be six trials from two different angles of knee bending.
For testing joint position sense you will again be blindfolded. You will then be presented an angle of knee bending on which you are to concentrate for 10 seconds. The experimenter will reposition your leg to a reference angle. Next, using the on/off switch you will attempt to reproduce the angle just presented to you. During the test you can stop motion in your knee by pressing the on/off switch should pain or feelings of instability occur. There will be six trials from two different angles of knee bending.
Stiffness Testing
To test knee stiffness you will be seated securely in a chair with the knee of the tested leg placed in a splint so extra movements do not occur during testing. Once your body and leg are stabilized, your leg will be positioned slightly bent and you will be asked to push for a few seconds against the device as hard as possible three times. You will then be asked to either relax or contract your muscles before the test begins. Sometime within the following 10 seconds your leg will be moved a short degree in backward or forward rotation by the device. These steps will be repeated several times. You will hold an emergency stop switch in your hand so that you can turn the device off at any point during the testing procedure. The tester will also hold an emergency stop switch and emergency stop sensors are in the device motor and on the attachment arm so that your leg will not be moved beyond your normal limits.
CONDITIONS OF SUBJECT PARTICIPATION
You should not participate in this research study if you have a history of 1. previous injuries to the low back, hips, knees (other than knee arthritis in the patient population) or ankles; 2. neurological problems; 3. unexplained falls; 4. rheumatoid arthritis; 5. use of devices such as a canes or walkers; 6. heart disease or high blood pressure not controlled by medication; 7. are pregnant (because of the risk of x-rays to pregnant women). The personnel at the office where x-rays will be taken will use their standard protocol and ask if you are or could be pregnant.
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Each subject will be ideutified by case number and only you and the investigators will have access to the data. Information and data will be stored on a computer until the studies are completed and published Neither your name nor any identifying information will be used in any publication or presentation resulting from this study. However, a statistical report of this research study and/or photographs that do not ideutify you may be used in a scientific paper or presentation. Following completion of the study, the data will be copied to a compact disk, removed from the computer and stored in a locked cabinet in Dr. Rudolph's research office. The data will be stored indefinitely and may be used in the future for comparisons with data from other research studies.
Your participation in this research is completely voluntary and you may withdraw from this study, or any part of it, at any time without peualty.
RISKS AND BENEFITS
The x-rays that will be taken are those that are used by physicians during standard clinical practice and you will be exposed to a level of radiation comparable to what you would receive if you had anx-ray at your orthopedic doctor's office. To reduce radiation exposure a lead apron will be placed over your body with your leg exposed for 3 of the 4 x-rays. During stress x-rays, you may feel pressure on the inside or outside part of your knee that will last approximately 15 seconds.
After strength and joint stiffness testing, you may experience some muscle and/or joint soreness within the few days following testing. The soreness is similar to what you may feel following a vigorous weight lifting routine. There is a risk of muscle and/or joint injury (i.e. pulled muscle, joint sprain) as a result oftesting, however in testing of over 100 subjects using these methods no one has had a muscle or joint injury. There will be no long-term risks to the participants. The close supervision, use of rest periods, emergeucy stop switches during testing will minimize risks involved with this protocol.
Risks associated with motion analysis testing and muscle activity recording include some minor skin irritation from the adhesive tape, fatigue during the testing but this risk is unlikely because appropriate rests periods will be provided. It is possible that the testing may cause soreuess in your knee, but the activities are similar to those that you do in every day life so the soreness should be no more than you experience after a busy day on your feet. Even though you will be allowed to practice on the moving platform you could experience a loss of balance and fall while walking on the moving platform. The risk of injuries from falling would be the same as if you tripped on a carpet and fell on the floor. The information regarding your walking patterns and the activity of your muscles is valuable because it will help with the development of training and rehabilitation programs for patients with arthritis.
If you are physically injured as a direct result of these research procedures, you will receive emergency first aid care. If you require additional medical treatrneut, you will be responsible for the cost. There are no direct benefits for your participation in this study,
FINANCIAL CONSIDERATIONS
For your participation, you will be compensated $25 for completion of x-ray analysis, $25 for completion of strength and functional assessment and $50 for completion of motion analysis testing.
Neither you nor your insurance company will be charged for any procedures included in this research study.
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Initials:
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CONTACTS
Further infonnation regarding this study may be obtained from the principal investigator, Dr.
Katherine Rudolph, 302-831-4235. Other questions regarding your rights as a research subject may be directed to Chair, Human Subjects Review Board, 302-831-2136.
SUBJECT ASSURANCES
I understand that participation in this study is voluntary and that I may withdraw at any time without consequence.
I have read this Consent F onn and have discussed the procedures described above with the investigators. I have been given the opportunity to ask questions regarding this study and they have been answered to my satisfaction.
I have been fully infonned of the above described procedures, with the possible risks and benefits and I agree to participate in the research study described above.
Date Subject Signature
Subject N arne (please print)
Investigator Signature Date
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