Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05893017 |
| Other study ID # |
E-68869993-511.06-765176 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 27, 2024 |
| Est. completion date |
July 25, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Hacettepe University |
| Contact |
Eren ARABACI |
| Phone |
+90507420742 |
| Email |
ernarbc[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Knee osteoarthritis (gonarthrosis) is one of the most common types of osteoarthritis. It is a
degenerative joint disorder characterized by pain, muscle weakness, and functional loss. It
is more frequently observed in the medial compartment of the knee joint. Additionally, it can
cause varus deformity by disrupting the alignment of the knee joint. There have been no
studies comparing the effects of conservative treatment approaches such as virtual reality
exercises, orthoses, and kinesio taping. Therefore, the aim of this current study is to
compare the effectiveness of virtual reality exercises alone and in combination with orthotic
approach and kinesio taping in individuals with knee osteoarthritis. The participants
included in the study will be randomly divided into three groups. The first group will
receive virtual reality exercises, the second group will receive virtual reality exercises
along with valgus orthosis, and the third group will receive virtual reality exercises
combined with kinesio taping treatment. The interventions will be applied three times a week
for eight weeks. Evaluations will be repeated before and after the exercise therapy. The
evaluations will include pain assessment using the Visual Analog Scale (VAS), muscle strength
measured by hand dynamometer, balance assessed by the Berg Balance Scale, proprioception
measured by stabilizer and inclinometer, joint range of motion measured by goniometer,
functional status evaluated by the WOMAC scale, lower extremity length measured by tape
measure, walking speed assessed by the 10-Meter Walk Test (10 MWT), quality of life measured
by the SF-36 questionnaire, kinesiophobia evaluated by the Tampa Scale for Kinesiophobia,
architectural features of the quadriceps femoris muscle assessed by ultrasound imaging, knee
OA score measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS), and medial
compartment distance of the knee calculated and recorded using computer-aided analysis on
anteroposterior radiographs.
Description:
The patients to be evaluated in this study are those who were diagnosed with gonarthrosis and
met the inclusion criteria. The study will be conducted with volunteer patients who accepted
the voluntary consent form.
After the power analysis made in our research, at least 20 individuals in each group with 80%
power and 0.05 margin of error.
It was found that a total of 60 individuals were required to participate.
Demographic and clinical data of the patients to be included in the study will be obtained.
The patients will be randomized with the help of a computer program (www.randomizer.org) and
divided into 3 groups. It will be formed by the patient group who received the Group-I
Virtual Reality Exercises training. In addition to Group-II Virtual Reality Exercises
training, it will be created by patients using valgus orthosis. Group-III will be formed by
patients who receive kinesio taping treatments in addition to virtual reality exercises
training. Virtual reality exercises will be applied with the help of Wii-Fit Balance Board
(Nintendo of America Inc, Redmond, WA). Virtual reality-based exercises increase patient
motivation and increase participation in treatment ensures its continuity. This will maximize
the patients' gains from treatment. It has been reported that exercise programs created with
Balance Board games support lower extremity movements and increase balance, and improve lower
extremity functions, making it more possible to reach rehabilitation goals. During the
implementation of virtual reality exercises in each group, patients will be verbally
questioned whether they experience headache, nausea or difficulty in maintaining balance. It
is planned to continue the application by giving the necessary rest intervals. If such
situations occur during the exercises, it will be reminded that the patient has the right to
leave the study. The patient's data will not be included in the study, as the patient's
condition is thought to affect the proper applicability of virtual reality exercises.
Virtual reality exercises are planned 3 times a week for 8 weeks, each session approximately
20-30 minutes and each game 3 repetitions. Balance games and yoga postures within the
equipment will be used. "Ski Slalom and Table Tilt" are balance games, "Tree" and "Chair" are
yoga posture poses.
Ski Slalom: Includes lateral weight transfer. The game can be played with squat position and
weight transfer to the left and right.
Table Tilt: It aims to improve balance in many ways. The game can be played by transferring
weight back and forth on the platform.
Tree pose: It is used to improve postural control. Chair pose: It is used to improve postural
control. Tree stance pose and Chair stance pose create abduction moment in the hip and
abduction moment in the knee. Low to moderate gonarthrosis of the hip abduction moment It has
been reported that it will reduce the load on the medial compartment in patients.
Valgus orthosis; reducing the overload in the medial compartment of the knee showing varum
alignment and it aims to increase the function. Increased activity and decreased pain may
delay the need for surgery. Some studies on the use of valgus orthoses have shown significant
reductions in pain and improvements in function. In addition, loading in the medial
compartment was found to decrease. In a study examining the effects of valgus brace on gait
symmetry; It was found that the gait was more symmetrical both when first put on and after
wearing the corset for 3 months. It was concluded that the brace is clinically effective.
Valgus knee braces are strong biomechanical and clinical effects.
Kinesio taping; It will be applied to the quadriceps femoris and hamstring muscles of the
patients as recommended by Kenzo Kase. For the quadriceps femoris muscle, the patient should
be in the supine position with the knees straight. Y shaped tape will be used. The tape will
be applied 5 cm below the SIAS with 25% tension, when it comes to the patella, it will be
Y-shaped, starting from the proximal of the patella without tension by flexing the knee a
little, and turning around it, and the taping will be finished in the inferior of the
patella. Y-shaped tape will be used for hamsting muscle application. For taping, the patient
should be standing and leaning forward from the trunk. The band will start from the ischial
tuberosity and come to the back of the knee and will end medial and lateral to the knee.
Kinesio tape application will be applied immediately after the end of the virtual reality
exercises session. Taping will be done 3 times a week for 8 weeks.
VAS: One of the most common problems in gonarthrosis is pain. Pain assessment will be done
with Visual Analogue Scale (VAS). VAS; It is used to digitize the severity of pain that
cannot be measured numerically. The two end definitions (0: No pain, 10: Unbearable pain) are
written on the two ends of the 10-centimeter scale and the patient is asked to mark where his
or her pain is in the scale. This method, which is easy to apply, is accepted and widely used
in all the literature. A high score indicates that the severity of pain is high. Pain
intensity will be evaluated separately while sitting, resting, standing and climbing stairs.
Measurement of Knee Extension Muscle Strength: In order to measure muscle strength, methods
such as manual muscle testing, isokinetic and isometric dynamometer or hand-held dynamometer
(HHD) are used in the clinic. HHDs are devices that measure maximum isometric muscle
strength. Its advantages are that it is easy to use, easy to carry and measurements can be
made in a short time. A hand dynamometer (MicroFet 2 HHD) will be used to measure the knee
extension muscle strength of the patients. Measurements will be recorded in kilograms.
patient for measurement; The knees are flexed at 900 degrees, the feet are free and the arms
are crossed at the shoulders, without support. During the measurement, the thigh to be
measured with one hand is stabilized after the patients have completed their maximum knee
extension. The hand holding the dynamometer is placed perpendicular to the leg, 1-2 cm above
the malleolus level. Patients who complete knee extension are asked to maintain maximum
isometric contraction for 5 seconds. 3 consecutive maximum contraction values are averaged at
thirty-second intervals.
Proprioceptive Force Sense Evaluation: It will be evaluated with a pressurized biofeedback
device. Measurements will be applied similarly to procedures for assessing joint position
sense. While the patients are lying on the treatment bed in the supine position, the
biofeedback device is placed under the knee and the pressure is adjusted to 20mmHg. They are
asked to contract and hold for 5 seconds. The highest value read from the device during
contractions of the patients is recorded in mmHg. 50% of the maximum value is recorded for
use in the evaluation of proprioceptive strength sense. Then, isometric quadriceps femoris
contraction is requested until the calculated proprioceptive force sense pressure value is
reached. They are told to stay in this position for 5 seconds and then relax. Afterwards,
individuals were asked to say when they thought they had reached this value without looking
at the device screen. When the patients say "ok", the value on the screen is saved. The
difference between this value and the calculated proprioceptive force sense value is recorded
in mmHg. Measurements are repeated 3 times and the average is considered as the test result.
High deviation scores indicate poor knee joint proprioception. It will be confirmed that
there is no flexion contracture or extension limitation in the knee joint before the
evaluation can be performed. It is also stated in the exclusion criteria of the study.
Lower Extremity Length Measurement: It is performed in order to compare the changes in the
bone structure with the other side. Measurements are made with an inelastic tape measure. The
patients to be measured are placed in the supine position. The distance between the
trochanter major and the medial malleolus will be used for lower extremity length
measurement. Measurements will be recorded in centimeters.
Lower Extremity Joint Range of Motion: One of the methods used to evaluate the joint range of
motion in the clinic is the measurement made with the help of a goniometer. Range of motion
assessment can be used to determine functionality and measure the effectiveness of treatment.
There are many different types. Knee flexion range of motion measurements will be made with
the patient lying in the prone position. In this study, measurements will be made using a
universal goniometer. Measurements will be made 3 times and the arithmetic average will be
recorded in degrees.
WOMAC (Western Ontario-Macmaster Osteoarthritis Score): It is used to evaluate the functional
status of patients with coxarthrosis and gonarthrosis. The validity and reliability of the
test was done by Tuzun et al. It evaluates disability due to osteoarthritis. It consists of 3
parts: pain, stiffness and loss of physical function. The test, which consists of twenty-four
items, is scored with a Likert scale. Each item is scored between 0 and 4. As a result of the
test, a minimum of 0 points and a maximum of 96 points are taken. High score is associated
with poor functional status.
10 Meter Walking Test: It is a test used to evaluate walking speed. The first 3 and the last
3 meters of the created 16-meter track are not included in the time calculation. Time starts
when the patient's first foot crosses the starting line, and ends when the second foot
crosses the finish line. Three repetitions are performed and the average is taken. Evaluation
will be performed by allowing adequate rest intervals between repetitions.
Tibiofemoral angle: It is calculated by AP X-ray taken while the patient is in the standing
position. It is found by the angle between the anatomical axis of the femur and the
anatomical axis of the tibia. Its normal value is between 2.20 and 7.40. This angle is
affected by all angle-related values of the lower extremity. It is highly correlated with
functional capacity. An angle above the normal value indicates valgus, and a decrease below
the normal value indicates varus deformity in the lower extremity.
Knee medial compartment distance: The minimum width remaining medially between the tibia and
the femur will be recorded in millimeters. The minimum joint space width will be measured as
the distance between the bones in the medial tibiofemoral region. The minimum distance is
between the distal femur and the proximal tibia. The point where the convex line of the
medial condyle of the femur is lowest is marked. From this point, the place where the
perpendicular drawn on the ground intersects with the tibial plateau is marked. The medial
compartment distance of the knee is calculated by recording the distance in millimeters
between these two marked points. The decrease in the distance can be interpreted as an
increase in the varus deformity of the knee.
KOOS (Knee Injury and Osteoarthritis Outcome Score): It is used to evaluate the symptoms and
functional status of knee OA. It consists of 5 subgroups. These are pain, activities of daily
living, functional status in sports and leisure activities, knee-related quality of life. It
consists of 42 questions in total. Each subscale is scored between 0 and 100 points. A low
score indicates an excess of the severity of the problem. Changes of ten points or more are
interpreted as clinically significant changes. It is a Turkish validity and reliability
scale.
SF-36: It is a scale used to evaluate quality of life. Turkish validity and reliability
studies were conducted. The scale consists of 36 questions. It is divided into its own
subheadings and used to measure the functional status of the person. It consists of eight
parts. These sections are: social competence, cognitive health status, physical competence,
pain, emotional strength, energy, general health perception, and physical strength. These
parameters have different ratings. The scale is scored between 0 and 100 points in total. An
increase in the score is interpreted as an improvement in health status.
Berg Balance Scale: It is used to evaluate both static and dynamic balance. It is a scale
with Turkish validity and reliability. It consists of 14 items used in ADLs with increasing
difficulty levels. The scoring of each item is between 0 and 4. The lowest score is 0 points
and the highest 56 points. A score of 45 and above indicates good balance.
Tampa Kinesiophobia Scale (TKS) is a 17-item scale developed to measure fear of
movement/re-injury. The scale includes the parameters of injury/re-injury and fear-avoidance
in work-related activities. Turkish adaptation study Tunca Yılmaz Ö. carried out by et al.
4-point Likert scoring on the scale (1 = I strongly disagree, 4 = Totally I agree) is used.
After reversing items 4, 8, 12 and 16, a total score is calculated. The person gets a total
score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
USG: Pennation angle calculation and muscle thickness measurement will be performed at the 4
heads of the Quadriceps Femoris muscle (vastus medialis, lateralis, intermedius and rectus
femoris) before and after the treatment. These measurements will be evaluated from the middle
of the thigh (between the trochanter major of the femur and the midpoint of the lateral
condyle of the femur) while the patient is lying in the supine position. Muscle thickness
will be measured as the distance between the superficial and deep aponeuroses by applying the
vertical and maximum pressure of the USG probe. Pennation angle measurement will be
determined by placing the USG probe longitudinally from the middle of the thigh and measuring
the angles where the muscle fascicles attach to the deep aponeurosis.
Baseline Digital Inclinometer: It is used to evaluate joint position sense and range of
motion in the clinic. It is a calibrated device with a margin of error of 1 degree. Position
sense measurement knee extension For the right and left extremities, it will be done in the
eyes open and eyes closed positions. The reposition angle method will be used in the
measurement of joint position sense. According to this method; The patient's extremity is
taken to the position where it should be taken by the physiotherapist. In this position, the
patient is asked to remember this position by waiting for 5 seconds. In this position, the
patient is asked to remember this position by waiting for 5 seconds. The patient is then
asked to return the extremity to that position. In the measurement of knee extension, the
inclinometer is fixed on the tibia while the patient sits on the side of the bed with their
knees flexed at 90 degrees. From the position of the patient; 30 degrees and 60 degrees knee
extension is requested. 3 repetitions are taken and the average is recorded.
