ANZCTR - Registration

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

Scientific title

Biofeedback-assisted exercise in the rehabilitation of patients after total knee arthroplasty

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Total knee arthroplasty

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

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]

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]

Self-reported functional status of the knee using Knee injury and Osteoarthritis Outcome Score (KOOS), Croatian version LK1.0

Timepoint [1]

Day 1 of the rehabilitation, Day 21 of the rehabilitation

Primary outcome [2]

Quality of life using EQ-5D-5L questionnaire (Croatian version).

Timepoint [2]

Day 1 of the rehabilitaion, Day 21 of the rehabilitation

Primary outcome [3]

Self-reported levels of pain using Numeric Rating Scale (NRS)

Timepoint [3]

Day 1 of the rehabilitaion, Day 21 of the rehabilitation

Secondary outcome [1]

Patient's functional status of the lower extremity using 30s Chair Stand Test

Timepoint [1]

Day 1 of the rehabilitaion, Day 21 of the rehabilitation

Secondary outcome [2]

Patient's mobility using Timed up & Go Test

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities

Date of first participant enrolment

Anticipated

1/11/2018

Actual

1/11/2018

Date of last participant enrolment

Anticipated

2/12/2019

Actual

2/12/2019

Date of last data collection

Anticipated

23/12/2019

Actual

23/12/2019

Sample size

Target

200

Accrual to date

Final

116

Recruitment outside Australia

Country [1]

Croatia

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Bizovacke Toplice Rehabilitation Centre

Address [1]

Bizovacke Toplice Rehabilitation Centre
Suncana 39
31222 Bizovac
Croatia

Country [1]

Croatia

Primary sponsor type

Individual

Name

Iva Sklempe Kokic, PhD

Address

Faculty of Kinesiology,
University J. J. Strossmayer in Osijek,
31000 Osijek, Croatia

Country

Croatia

Secondary sponsor category [1]

Individual

Name [1]

Matko Vuksanic, PT

Address [1]

Bizovacke Toplice Rehabilitation Centre
Suncana 39
31222 Bizovac
Croatia

Country [1]

Croatia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics commitee, Bizovacke Toplice Rehabilitation Centre

Ethics committee address [1]

Bizovacke Toplice Rehabilitation Centre,
Suncana 39, 31222 Bizovac, Croatia

Ethics committee country [1]

Croatia

Date submitted for ethics approval [1]

20/08/2018

Approval date [1]

04/09/2018

Ethics approval number [1]

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

A/Prof Iva Sklempe Kokic

Address

Faculty of Kinesiology, University J. J. Strossmayer in Osijek, Drinska 16a, 31000 Osijek, Croatia

Country

Croatia

Phone

+385915082854

Fax

ivask@kifos.hr

Contact person for public queries

Name

Dr Iva Sklempe Kokic

Address

Faculty of Kinesiology, University J. J. Strossmayer in Osijek, Drinska 16a, 31000 Osijek, Croatia

Country

Croatia

Phone

+385915082854

Fax

ivask@kifos.hr

Contact person for scientific queries

Name

Dr Iva Sklempe Kokic

Address

Faculty of Kinesiology, University J. J. Strossmayer in Osijek, Drinska 16a, 31000 Osijek, Croatia

Country

Croatia

Phone

+385915082854

Fax

ivask@kifos.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

How or where can data be obtained?

Access subject to approvals by Principal Investigator

What supporting documents are/will be available?

Doc. No.	Type	Email
14800	Study protocol	ivask@kifos.hr
14801	Statistical analysis plan	ivask@kifos.hr
14802	Informed consent form	ivask@kifos.hr
14803	Clinical study report	ivask@kifos.hr
14804	Ethical approval	ivask@kifos.hr
14805	Analytic code	ivask@kifos.hr

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.

Trial Review

Documents added manually

Documents added automatically