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Trial registered on ANZCTR


Registration number
ACTRN12616001407482
Ethics application status
Approved
Date submitted
13/09/2016
Date registered
10/10/2016
Date last updated
10/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of selected kinesiotaping technique in the treatment of patients with anterior cruciate ligament rupture.
Scientific title
Evaluation of selected kinesiotaping technique in the treatment of patients with anterior instability of the knee joint.
Secondary ID [1] 290151 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anterior cruciate ligament injury 300270 0
Condition category
Condition code
Musculoskeletal 300138 300138 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 300139 300139 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will have the double measurements:
1. Before application of kinesiotaping (KT)
2. After the application of kinesiotaping
After the application of kinesiotaping each patient will have 1 hour to adjust to the application. This will allow the assess early impact of the tape to limiting the anterior translation of the tibia.
The examination will involve:
1. Measurement of kinematic and kinetic gait parameters based on a three-dimensional motion analysis, with the use of the BTS Smart system together with a dynamometric platform. The analysis will cover:
-angular changes in 3 planes of motion of knee, hip and ankle joints
-changes in the length of selected muscles
- changes in ground-reaction forces
-spatio-temporal parameters: the number of steps per minute, single and double support time, stride length and time, gait velocity
2. Measurement of the maximum muscle movement of knee extensors and flexors- during an isometric contraction in standard positions, by means of a dynamometer
3. Measurement of selected stabilometric parameters while standing on one or two feet, with the use of a stabilographic platform

BTS Smart System
The BTS SMART DX system for complex motion analysis based on the technology of passive markers reflecting the emitted IR radiation in conjunction with a dynamographic platform enables the comprehensive evaluation of kinetic and kinematic gait parameters.
The data station is a specialised computer which collects and processes the data recorded by the cameras. The so-called passive markers allow the spatial reconstruction of a skeleton model with characteristic bone points and joint axes.
The markers are pasted directly to a patient’s skin. Their arrangement reflects the pattern of the biomechanical model. They are glued along joint axes at an appriopriate distance from the centre of joints and at characteristic points on the head, chest and pelvis. It enables a spatial representation of these segments of the body as well as the measurement of individual parameters- the dimensions of pelvis and the span of the chest.
The system is accompanied by a dynamometric platform assesing pressure force, which makes it possible to calculate force moments in individual joints and also the power (downloaded or generated) transported within joints. The analysis of ground-reaction forces is a crucial element of movement assessment, tracking forces and ground reaction moments in three planes allows to verify the functioning of the motor organ. The scrutiny will make it possible to combine the change of patients’ gait pattern with the observation of the arrangement of individual segments of the body.

Maximum muscle movement measurement
The measurement will be made by dynamometer in standard positions for the knee extensor and flexor force assesement.
The obtained results of maximum force (Fmax) will enable the calculation of maximum muscle force (Mmax) and relative moments (Mw).
Due to the standarization of results, the research will make use of the values of relative moments.
The value of a force torque is calculated from the equation:
Mmax= Fmax * d [Nm]
where:
Mmax= the maximum moment of the measured muscle group
Fmax= the maximum force recorded during an isometric contraction
d- arm of an external force
On their basis the values of relative moments will be evaluated from :
Mw=Mmax/m [Nm/kg]
where:
Mw- maximum moment of a muscle group
Mmax- maximum force
m- the subject’s weight

Isometric muscle strength testing is a safe method of force evaluation as no dislocations of muscle attachments occur, and therefore the probability of muscle damage is very small. However, due to pain and psychological factors it is hard to enforce maximum measurements. Despite clear instructions for the examination, patients, owing to pain and the threat of dislocating the thigh resulting from the lack of a frontal knee brace (ACL), are guided by the subjective sense of their maximum abilities. Pre-traumatic strength should also be taken into account (each person represented a different level of physical activity, and thus had a different level of muscle force).
However, despite those subjective pain and psychological conditions, the measurement clearly shows strength capabilities of the subjects. Thanks to the electronic measurement, precisely defined values of maximum strength abilities of the patients can be obtained.

Stabilometric platform
The measurement will be taken on a stabilometric platform CQStab2P/ two-platform version, comprising a tensometric platform and a compatible PC computer with CQStab software for collecting and processing the data.
The examination involves recording and time analysis of transfers of the point of putting the resultant ground reaction force when maintaining balance while standing on the platform. During the measurement tensometric sensors register the foot center of pressure and its displacement in the frontal and sagittal plane. The projection of the COP is recorded as a point and as a dynamic parameter changing its position in time.
The signal describing dislocations of COP is the sum of the center of gravity signal and corrective forces generated by appropriate muscles.
The subject is standing on the platform equipped with tensomtric sensors recording foot pressure and its displacement in the frontal and sagittal plane.
The results are presented in the form of charts called statokinesiogram or stabilogram.
The following parametres are obtained:
SP- the length of a complete path calculated in both axes [mm]
SPAP- the length of the statokinesiogram counted towards the Y axis [mm]
SPML- the length of the statokinesiogram counted towards the X axis [mm]

Stabilogram - inicates the COP motion on the coordinate system in which the x axis presents medio-lateral sway (ML), whereas the y axis shows anterior-posterior sway (AP)
Statokinesiogram- depicts the location of COP as a time function. Medio-lateral and anterior-posterior movements are investigated separately.
The test will be carried out after a 5-minute rest in a sitting position. The examinees will be asked to enter frontally and barefoot on the platform and adopt a relaxed upright position with their upper limbs along the body and lower limbs straight. During the measurement the examined person will focus on a graphic reference in the shape of a black printed circle (r = 9cm) placed at his eye level, two meters away from the platform. Then he stands on one foot and bends the other leg in the knee joint without changing the position of the hip joint. While standing on one foot the patient cannot keep legs together, prop up on the examined limb. The examination is conducted in silence and natural daylight. To maintain hygienic conditions, the platform is sterilized with antiseptics and disinfectants after each patient.
During the first test two consecutive assessments will be made, each lasting 30 seconds:
-standing on the right lower limb with eyes open (the left knee bended)
- standing on the left lower limb with eyes open (the right knee bended)
Next, an experienced physiotherapist applies the kinesio tape.
After the application the examinees will be asked to adjust to the application (for 1 hour the examinees will be walking around the room and at the end he/she again will have to rest for 5 minutes in a sitting position) followed by another examination, including two measurements analogous to the previous test under the same conditions.

Application of kinesiotape
During this research ligament technique of kinesiotaping (which limiting the anterior translation of the tibia) will be taken into consideration. Application of a KT tape is to stabilize the knee joint. One strip of an “I-type” kinesio tape will beused. During the application the patient will be lying in the supine position. The knee will be flexed to about 45 degrees.
The base of a previously measured piece of tape will be applied without tension on the patient's knee at the height of the patellar tendon. Then the tape will be applied symmetrically on the medial and lateral side with 75% tension, through the knee up to the femur. During the application the patient will be asked to extend the knee while the therapist applied the tape in the cranial-dorsal direction. The last five centimetres of tape will be applied without tension on both the lateral and medial side.

Overall duration of the intervention – 3 hours:
1. 1 hour for before application measurements,
2. 1 hour for adjustment to kinesiotaping application,
3. 1 hour for after application measurements

Intervention code [1] 295901 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299620 0
Muscle force assessed by dynamometer and kinematic parameters of gait assessed by BTS Smart System.
Timepoint [1] 299620 0
Immediately after application of kinesiotaping
Primary outcome [2] 299621 0
Knee stability assessed by Stabilometric platform.
Timepoint [2] 299621 0
Immediately after application of kinesiotaping
Secondary outcome [1] 327704 0
Sense of stability of the knee joint measured by patient by a subjective scale of 1 to 10.
Timepoint [1] 327704 0
immediate after kinesiotaping appliction
Secondary outcome [2] 328094 0
Quadriceps muscle strength assessed by dynamometer
Timepoint [2] 328094 0
at 6 months post surgery and rehabilitation

Eligibility
Key inclusion criteria
1. Chronic instability of the knee confirmed by an imaging examination: CT and instability tests performed by an orthopaedist (anterior drawer test, Pivot shift).
2. No other injuries or illnesses that may affect the outcome of the tests (e.g. meniscus injury, degenerative changes in the joints of the leg).
3. A voluntary consent of the patient to participate in the study.
4. The patients had not taken medications affecting motor coordination.
Minimum age
20 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Partial damage to the meniscus,
2. Musculoskeletal injuries and diseases that may affect the test results (i.e. meniscus injury, degenerative changes in the joints of the leg),
3. Acute instability of the knee (instability resulting from ACL injury, persisting for 4 weeks after the injury)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power analysis will be performed to determine the size of the test group. Power analysis will be also performed in order to estimate the size of the research group.
40 patients were enrolled for the research, which accounted for 75% of all patients operated on within one calendar year in the clinic. Statistical assumptions supporting sample size calculations will be made on the basis of arithmetic means, standard deviation and the value of correlation between the measurements before and after the application of kinesiotaping.

In calculations general linear models (GLM) will be used. Analysis of variances will be conducted for repeated measurements and scheduled comparisons to examine detailed differences between measurements in the study group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8226 0
Poland
State/province [1] 8226 0
Malopolska

Funding & Sponsors
Funding source category [1] 294519 0
University
Name [1] 294519 0
University of Physical Education in Krakow
Address [1] 294519 0
Al. Jana Pawla II 78
31-571 Krakow
Country [1] 294519 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Krakow
Address
Al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 293383 0
None
Name [1] 293383 0
Address [1] 293383 0
Country [1] 293383 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295953 0
Bioethics Commission at the Regional Medical Chamber in Krakow
Ethics committee address [1] 295953 0
ul. Krupnicza 11A,
31-123 Kraków
Ethics committee country [1] 295953 0
Poland
Date submitted for ethics approval [1] 295953 0
01/04/2014
Approval date [1] 295953 0
08/04/2014
Ethics approval number [1] 295953 0
No. 19/KBL/OIL/2014

Summary
Brief summary
Background
The purpose of the research was to discuss the influence of kinesiotaping on the biomechanical image of gait and of stabilographic parameters in patients with anterior instability of the knee.
Research material comprised a group of 31 patients . In all patients total tear of the ACL was diagnosed and they had been referred for the reconstruction surgery. The BTS SMART DX. system was used to illustrate the biomechanical gait scheme. The study made use of measurements of static stabilographic parameters with a stabilographic platform as well as measurements of the maximum muscle torque of extensors and flexors of the knee.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1112 1112 0 0

Contacts
Principal investigator
Name 69006 0
Dr Katarzyna Ogrodzka
Address 69006 0
al. Jana Pawla II 78
31-571 Krakow
Country 69006 0
Poland
Phone 69006 0
+48126831065
Fax 69006 0
Email 69006 0
katarzyna.ogrodzka@awf.krakow.pl
Contact person for public queries
Name 69007 0
Dr Katarzyna Ogrodzka
Address 69007 0
al. Jana Pawla II 78
31-571 Krakow
Country 69007 0
Poland
Phone 69007 0
+48126831065
Fax 69007 0
Email 69007 0
katarzyna.ogrodzka@awf.krakow.pl
Contact person for scientific queries
Name 69008 0
Dr Katarzyna Ogrodzka
Address 69008 0
al. Jana Pawla II 78
31-571 Krakow
Country 69008 0
Poland
Phone 69008 0
+48126831065
Fax 69008 0
Email 69008 0
katarzyna.ogrodzka@awf.krakow.pl

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary