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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
30/10/2018
Date data sharing statement initially provided
30/10/2018
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
Scientific title
Biofeedback-assisted exercise in the rehabilitation of patients after total knee arthroplasty
Secondary ID [1] 296332 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total knee arthroplasty 310045 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308798 308798 0 0
Physiotherapy
Musculoskeletal 308799 308799 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 312659 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 307781 0
Self-reported functional status of the knee using Knee injury and Osteoarthritis Outcome Score (KOOS), Croatian version LK1.0
Timepoint [1] 307781 0
Day 1 of the rehabilitation, Day 21 of the rehabilitation
Primary outcome [2] 307782 0
Quality of life using EQ-5D-5L questionnaire (Croatian version).
Timepoint [2] 307782 0
Day 1 of the rehabilitaion, Day 21 of the rehabilitation
Primary outcome [3] 307783 0
Self-reported levels of pain using Numeric Rating Scale (NRS)
Timepoint [3] 307783 0
Day 1 of the rehabilitaion, Day 21 of the rehabilitation
Secondary outcome [1] 352849 0
Patient's functional status of the lower extremity using 30s Chair Stand Test
Timepoint [1] 352849 0
Day 1 of the rehabilitaion, Day 21 of the rehabilitation
Secondary outcome [2] 352850 0
Patient's mobility using Timed up & Go Test
Timepoint [2] 352850 0
Day 1 of the rehabilitaion, Day 21 of the rehabilitation

Eligibility
Key inclusion criteria
Patients admitted to inpatient postoperative rehabilitation after TKA which consented to participate in the study.
Minimum age
18 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, block sizes 4
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
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] 20935 0
Croatia
State/province [1] 20935 0

Funding & Sponsors
Funding source category [1] 300934 0
Hospital
Name [1] 300934 0
Bizovacke Toplice Rehabilitation Centre
Address [1] 300934 0
Bizovacke Toplice Rehabilitation Centre
Suncana 39
31222 Bizovac
Croatia
Country [1] 300934 0
Croatia
Primary sponsor type
Individual
Name
Iva Sklempe Kokic, PhD
Address
College of Applied Sciences "Lavoslav Ruzicka" in Vukovar,
Department of Health Studies,
32000 Vukovar, Croatia
Country
Croatia
Secondary sponsor category [1] 300504 0
Individual
Name [1] 300504 0
Matko Vuksanic, PT
Address [1] 300504 0
Bizovacke Toplice Rehabilitation Centre
Suncana 39
31222 Bizovac
Croatia
Country [1] 300504 0
Croatia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301701 0
Ethics commitee, Bizovacke Toplice Rehabilitation Centre
Ethics committee address [1] 301701 0
Bizovacke Toplice Rehabilitation Centre,
Suncana 39, 31222 Bizovac, Croatia
Ethics committee country [1] 301701 0
Croatia
Date submitted for ethics approval [1] 301701 0
20/08/2018
Approval date [1] 301701 0
04/09/2018
Ethics approval number [1] 301701 0
71/2018/I

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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87818 0
Dr Iva Sklempe Kokic
Address 87818 0
Department of Health Studies,
College of Applied Sciences "Lavoslav Ruzicka" in Vukovar
Zupanijska 50, 32000 Vukovar
Croatia
Country 87818 0
Croatia
Phone 87818 0
+385915082854
Fax 87818 0
Email 87818 0
iva.sklempe-kokic@vevu.hr
Contact person for public queries
Name 87819 0
Dr Iva Sklempe Kokic
Address 87819 0
Department of Health Studies,
College of Applied Sciences "Lavoslav Ruzicka" in Vukovar
Zupanijska 50, 32000 Vukovar
Croatia
Country 87819 0
Croatia
Phone 87819 0
+385915082854
Fax 87819 0
Email 87819 0
iva.sklempe-kokic@vevu.hr
Contact person for scientific queries
Name 87820 0
Dr Iva Sklempe Kokic
Address 87820 0
Department of Health Studies,
College of Applied Sciences "Lavoslav Ruzicka" in Vukovar
Zupanijska 50, 32000 Vukovar
Croatia
Country 87820 0
Croatia
Phone 87820 0
+385915082854
Fax 87820 0
Email 87820 0
iva.sklempe-kokic@vevu.hr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
For IPD meta-analyses
By what mechanism will data be made available?
Access subject to approvals by Principal Investigator
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
Summary results
Not applicable