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Trial registered on ANZCTR
Registration number
ACTRN12618001782224
Ethics application status
Approved
Date submitted
14/10/2018
Date registered
30/10/2018
Date last updated
25/01/2022
Date data sharing statement initially provided
30/10/2018
Date results information initially provided
25/01/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Biofeedback-assisted exercise in the rehabilitation of patients after total knee arthroplasty – effects on functional outcomes and quality of life
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Scientific title
Biofeedback-assisted exercise in the rehabilitation of patients after total knee arthroplasty
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Secondary ID [1]
296332
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Total knee arthroplasty
310045
0
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Condition category
Condition code
Physical Medicine / Rehabilitation
308798
308798
0
0
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Physiotherapy
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Musculoskeletal
308799
308799
0
0
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention includes 21 day of inpatient postoperative rehabilitation after TKA according to standard protocol which consists of daily sessions of land-based exercise therapy, application of physical agents (interferential current therapy and electrostimulation), group aquatic exercise and individual education. Each of 21 days of rehabilitation follows the same protocol, except Sundays when patients do not receive physiotherapy (there are three Sundays during the patients' stay at the hospital). There are 18 days of rehabilitation consisting of: 50 minutes of land-based exercise, 30 minutes of aquatic exercise, 10 minutes of interferential current therapy, and 10 minutes of electrostimulation. All interventions are performed on a daily basis, except individual education.
Programme of land-based exercise consists of 20 exercises. Patients perform 7 variations of isometric exercises for thigh muscles and 13 dynamic exercises for lower limb which include active straight leg raise (upward and combined upward and into hip abduction) from long-sitting position with and without elastic band, hip abduction straight leg raise (and in combination with hip flexion and extension), hip flexion in long-sitting position, leg extension in sitting position with elastic band, hip abduction from sitting position, hip flexion from sitting position, hip flexion and leg exstension exercise on a Swiss ball, and pelvic lift exercise. Isometric exercise is performed in sets of 1, 5 repetitions with maximal efort lasting 5 seconds. Dynamic exercise is performed in 1-2 sets, 10 repetitions. Progression of dynamic exercise is achieved with elastic band and during the last 6 days of rehabilitation ankle weights (1kg) are included.
Interferential current therapy is provided using Myomed 632 device (Enraf-Nonius B. V., Rotterdam, The Netherlands) in duration of 10 minutes using symetrical waves, phase duration of 100 µs, phase interval 0 µs, impulse frequency 80 Hz, modulation frequency 0 Hz, modulation programme 1/1 sec, with intensity in mA according to patient's tolerance. Electrostimulation is provided using Myomed 632 device (Enraf-Nonius B. V., Rotterdam, The Netherlands) in duration of 10 minutes using symetrical waves, phase duration of 500 µs, phase interval 0 µs, impulse frequency 1Hz, modulation frequency 0 Hz, modulation programme 1/1 sec, with intensity in mA according to patient's tolerance.
Group aquatic exercise include 13 exercises for range of motion and strength (standing toe raise, standing heel raise, semi-squats, hip flexion, extension and abduction in standing position and while floating in water, knee flexion and extension in standing position and while floating in water).
Individual education is mainly targeted to long-term care of the prosthesis regarding how to return to activities of daily life, recommended and non-recommended activities, coping with postoperative pain and prevention of blod clots by regular physical activity. It is provided by physiotherapists before and after exercise session, orally. Education is provided once, at the start of the rehabilitation, with additional explaining as necessary (if patients has questions).
A portion of land-based exercise therapy will be biofeedback-asissted (Myomed 632, Enraf-Nonius B. V., Rotterdam, The Netherlands), with individually adjusted targets for muscular isometric contraction, according to manufacturer's instruction. Biofeedack is provided by superficial electromyography (EMG) unit, e. g. electrical activitiy of a muscle is registered and passed on as quantitative information (feedback) to the patient and the physiotherapist in real time, during exercise. That way, the patient is able to monitor the strength of the contraction on screen and try to achieve adequate intensity of the muscular isometric contraction. The device is attached to the patient via three electrodes, two EMG electrodes, and one reference electrode. The EMG electrodes are placed at ¼ th of the muscle belly of the anterior portion of the m. quadriceps femoris. The reference electrode is placed on the anterior portion of the tibia of the opposite leg. At the beginning of the biofeedback-assisted exercise the patient will perform maximal isometric contraction of the m. quadriceps femoris to establish the treshold, e.g. the target intensity of the muscular contraction. Sensitivity of the EMG signal is set to 200 µV to achieve good visibility to a patient, e.g. to achieve good graphical representation of the muscle's electrical activity on the screen of the device. After the patient performed maximal isometric contraction this is recored by the device. The pyhsiotherapist in charge will set the treshold which will be the value of the muscular contraction the patient should acomplish during his exercise, e.g. during periods of active muscular contraction. The patient should contract the muscle above the treshold which is visible on the screen. The treshold is set to 80% of the maximal isometric contraction achieved at the start of the session. Biofeedback-assisted exercise consists of isometric contractions of the m. quadriceps femoris for 15 minutes (10 seconds periods of contraction and 10 seconds periods of relaxation between contractions).
Intervention will be provided once per day, face to face, by physiotherapist in a special hospital for rehabilitation. Adherence to the treatment will be monitored by physiotherapist in charge.
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Intervention code [1]
312659
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Rehabilitation
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Comparator / control treatment
Control group will be given the same rehabilitation protocol except for biofeedback-assisted exercise.
Intervention includes 21 day of inpatient postoperative rehabilitation after TKA according to standard protocol which consists of daily sessions of land-based exercise therapy, application of physical agents (interferential current therapy and electrostimulation), group aquatic exercise and individual education. Each of 21 days of rehabilitation follows the same protocol, except Sundays when patients do not receive physiotherapy (there are three Sundays during the patients' stay at the hospital). There are 18 days of rehabilitation consisting of: 50 minutes of land-based exercise, 30 minutes of aquatic exercise, 10 minutes of interferential current therapy, and 10 minutes of electrostimulation. All interventions are performed on a daily basis, except individual education.
Programme of land-based exercise consists of 20 exercises. Patients perform 7 variations of isometric exercises for thigh muscles and 13 dynamic exercises for lower limb which include active straight leg raise (upward and combined upward and into hip abduction) from long-sitting position with and without elastic band, hip abduction straight leg raise (and in combination with hip flexion and extension), hip flexion in long-sitting position, leg extension in sitting position with elastic band, hip abduction from sitting position, hip flexion from sitting position, hip flexion and leg exstension exercise on a Swiss ball, and pelvic lift exercise. Isometric exercise is performed in sets of 1, 5 repetitions with maximal efort lasting 5 seconds. Dynamic exercise is performed in 1-2 sets, 10 repetitions. Progression of dynamic exercise is achieved with elastic band and during the last 6 days of rehabilitation ankle weights (1kg) are included.
Interferential current therapy is provided using Myomed 632 device (Enraf-Nonius B. V., Rotterdam, The Netherlands) in duration of 10 minutes using symetrical waves, phase duration of 100 µs, phase interval 0 µs, impulse frequency 80 Hz, modulation frequency 0 Hz, modulation programme 1/1 sec, with intensity in mA according to patient's tolerance. Electrostimulation is provided using Myomed 632 device (Enraf-Nonius B. V., Rotterdam, The Netherlands) in duration of 10 minutes using symetrical waves, phase duration of 500 µs, phase interval 0 µs, impulse frequency 1Hz, modulation frequency 0 Hz, modulation programme 1/1 sec, with intensity in mA according to patient's tolerance.
Group aquatic exercise include 13 exercises for range of motion and strength (standing toe raise, standing heel raise, semi-squats, hip flexion, extension and abduction in standing position and while floating in water, knee flexion and extension in standing position and while floating in water).
Individual education is mainly targeted to long-term care of the prosthesis regarding how to return to activities of daily life, recommended and non-recommended activities, coping with postoperative pain and prevention of blod clots by regular physical activity. It is provided by physiotherapists before and after exercise session, orally. Education is provided once, at the start of the rehabilitation, with additional explaining as necessary (if patients has questions).
Intervention will be provided once per day, face to face, by physiotherapist in a special hospital for rehabilitation. Adherence to the treatment will be monitored by physiotherapist in charge.
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Control group
Active
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Outcomes
Primary outcome [1]
307781
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Self-reported functional status of the knee using Knee injury and Osteoarthritis Outcome Score (KOOS), Croatian version LK1.0
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Assessment method [1]
307781
0
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Timepoint [1]
307781
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Day 1 of the rehabilitation, Day 21 of the rehabilitation
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Primary outcome [2]
307782
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Quality of life using EQ-5D-5L questionnaire (Croatian version).
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Assessment method [2]
307782
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Timepoint [2]
307782
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Day 1 of the rehabilitaion, Day 21 of the rehabilitation
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Primary outcome [3]
307783
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Self-reported levels of pain using Numeric Rating Scale (NRS)
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Assessment method [3]
307783
0
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Timepoint [3]
307783
0
Day 1 of the rehabilitaion, Day 21 of the rehabilitation
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Secondary outcome [1]
352849
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Patient's functional status of the lower extremity using 30s Chair Stand Test
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Assessment method [1]
352849
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Timepoint [1]
352849
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Day 1 of the rehabilitaion, Day 21 of the rehabilitation
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Secondary outcome [2]
352850
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Patient's mobility using Timed up & Go Test
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Assessment method [2]
352850
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Timepoint [2]
352850
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Day 1 of the rehabilitaion, Day 21 of the rehabilitation
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Eligibility
Key inclusion criteria
Patients admitted to inpatient postoperative rehabilitation after TKA which consented to participate in the study.
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Minimum age
18
Years
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Maximum age
79
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients after revision TKA
Patients with comorbidites which not allow normal mobility (hemiparesis, severe diseases and conditions affecting internal organs)
Non-ambulantory patients before TKA where surgery is performed only for pain relief
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, block sizes 4
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Descriptive statistics for categorical variables will include absolute values and percentages, and for numeric variables mean, standard deviation, median and interquartile range, along with minimal and maximal values. Differences between experimental and control group will be analysed using appropriate parametric and/or non-parametric tests. We will also analyse pre- and post-intervention results in experimental and control group, and between groups pre- and post-intervention using appropriate statistics. Hypotheses will be accepted or rejected at p < 0.05. Power will be set at 0.8.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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Date of first participant enrolment
Anticipated
1/11/2018
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Actual
1/11/2018
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Date of last participant enrolment
Anticipated
2/12/2019
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Actual
2/12/2019
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Date of last data collection
Anticipated
23/12/2019
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Actual
23/12/2019
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Sample size
Target
200
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Accrual to date
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Final
116
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Recruitment outside Australia
Country [1]
20935
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Croatia
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State/province [1]
20935
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Funding & Sponsors
Funding source category [1]
300934
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Hospital
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Name [1]
300934
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Bizovacke Toplice Rehabilitation Centre
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Address [1]
300934
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Bizovacke Toplice Rehabilitation Centre
Suncana 39
31222 Bizovac
Croatia
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Country [1]
300934
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Croatia
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Primary sponsor type
Individual
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Name
Iva Sklempe Kokic, PhD
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Address
Faculty of Kinesiology,
University J. J. Strossmayer in Osijek,
31000 Osijek, Croatia
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Country
Croatia
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Secondary sponsor category [1]
300504
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Individual
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Name [1]
300504
0
Matko Vuksanic, PT
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Address [1]
300504
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Bizovacke Toplice Rehabilitation Centre
Suncana 39
31222 Bizovac
Croatia
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Country [1]
300504
0
Croatia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301701
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Ethics commitee, Bizovacke Toplice Rehabilitation Centre
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Ethics committee address [1]
301701
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Bizovacke Toplice Rehabilitation Centre,
Suncana 39, 31222 Bizovac, Croatia
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Ethics committee country [1]
301701
0
Croatia
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Date submitted for ethics approval [1]
301701
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20/08/2018
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Approval date [1]
301701
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04/09/2018
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Ethics approval number [1]
301701
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71/2018/I
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Summary
Brief summary
Postoperative rehabilitation after total knee arthroplasty (TKA) plays an important role after the surgery by facilitation of independence in transfers and ambulation and achieving functional goals for people. Currently, there is limited evidence and guidelines for rehabilitation after TKA including the type, timing, and dosage of rehabilitation interventions, including evidence regarding efficacy of biofeedback-assisted exercise in rehabilitation of these patients. The aim of the study is to investigate potential benefits of biofeedback-assisted exercise on functional recovery and postoperative pain after TKA. The main hypothesis of the study is that the patients who received biofeedback-assisted exercise achieve better functional recovery in comparison to patients who received rehabilitation without biofeedback-assisted exercise.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
87818
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A/Prof Iva Sklempe Kokic
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Address
87818
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Faculty of Kinesiology, University J. J. Strossmayer in Osijek, Drinska 16a, 31000 Osijek, Croatia
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Country
87818
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Croatia
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Phone
87818
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+385915082854
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Fax
87818
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Email
87818
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[email protected]
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Contact person for public queries
Name
87819
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Dr Iva Sklempe Kokic
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Address
87819
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Faculty of Kinesiology, University J. J. Strossmayer in Osijek, Drinska 16a, 31000 Osijek, Croatia
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Country
87819
0
Croatia
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Phone
87819
0
+385915082854
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Fax
87819
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Email
87819
0
[email protected]
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Contact person for scientific queries
Name
87820
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Dr Iva Sklempe Kokic
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Address
87820
0
Faculty of Kinesiology, University J. J. Strossmayer in Osijek, Drinska 16a, 31000 Osijek, Croatia
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Country
87820
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Croatia
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Phone
87820
0
+385915082854
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Fax
87820
0
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Email
87820
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data underlying published results only, after de-identification.
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When will data be available (start and end dates)?
Immediately following publication, no end date
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Available to whom?
Only researchers who provide a methodologically sound proposal
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Available for what types of analyses?
For IPD meta-analyses
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How or where can data be obtained?
Access subject to approvals by Principal Investigator
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
14800
Study protocol
[email protected]
14801
Statistical analysis plan
[email protected]
14802
Informed consent form
[email protected]
14803
Clinical study report
[email protected]
14804
Ethical approval
[email protected]
14805
Analytic code
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Effects of Electromyographic Biofeedback on Functional Recovery of Patients Two Months after Total Knee Arthroplasty: A Randomized Controlled Trial.
2022
https://dx.doi.org/10.3390/jcm11113182
N.B. These documents automatically identified may not have been verified by the study sponsor.
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