Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12622001130752
Ethics application status
Approved
Date submitted
8/08/2022
Date registered
17/08/2022
Date last updated
17/08/2022
Date data sharing statement initially provided
17/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Biofeedback-assisted exercise in the rehabilitation of patients after total hip arthroplasty – effects on functional outcomes and quality of life
Scientific title
Biofeedback-assisted exercise in the rehabilitation of patients after total hip arthroplasty – effects on functional outcomes and quality of life
Secondary ID [1] 307732 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total hip arthroplasty 327300 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324437 324437 0 0
Physiotherapy
Musculoskeletal 324438 324438 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention includes 21 day of inpatient postoperative rehabilitation after total hip arthroplasty (THA) 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 pelvic lift exercise from lying supine position (exercise 1), active straight leg raise from lying supine position with and without elastic band around ankles for the resistance (exercises 2 & 3), hip abduction with the knee in extension from lying supine position with and without elastic band around ankles for the resistance (exercises 4 & 5), hip and knee flexion from lying supine position with and without elastic band around feet for the resistance (exercises 6 & 7), hip and knee flexion toward the patient’s chin in lying supine position with patient’s legs on Swiss ball (exercise 8), shifting extended leg from Swiss ball on the therapy bed and vice versa in lying supine position (exercise 9), hip abduction with extended knee from side lying position (exercise 10), hip flexion and extension with knee extension from side lying position (exercise 11), knee flexion and extension from side lying position (exercise 12), knee extension from sitting position (exercise 13). Isometric exercise is performed in sets of 1, 5 repetitions with maximal effort 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 symmetrical 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 symmetrical 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 11 exercises for the range of motion and strength of the lower extremity muscles and include: standing heel raise (exercise 1), hip extension from standing position (exercise 2), semi-squats (exercise 3), hip flexion from standing position with the extended knee (exercise 4), hip and knee flexion from standing position (exercise 5), hip abduction from standing position (exercise 6), hip extension from standing position while holding the edge of the pool with hand (exercise 7), touching ipsilateral leg with the hand while the trunk is slightly bended forward (exercise 8), hip and knee flexion while floating on the water in supine position (exercise 9), hip abduction and adduction while floating on the water in supine position (exercise 10), and hip flexion with extended knee while simultaneously extending contralateral hip towards the bottom of the pool while floating in the water (exercise 11). Exercises are performed bilaterally.
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 blood 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 activity 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 threshold, 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 recorded by the device. The physiotherapist in charge will set the threshold which will be the value of the muscular contraction the patient should accomplish during his exercise, e.g. during periods of active muscular contraction. The patient should contract the muscle above the threshold which is visible on the screen. The threshold 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] 324206 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 total hip arthroplasty (THA) 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 pelvic lift exercise from lying supine position (exercise 1), active straight leg raise from lying supine position with and without elastic band around ankles for the resistance (exercises 2 & 3), hip abduction with the knee in extension from lying supine position with and without elastic band around ankles for the resistance (exercises 4 & 5), hip and knee flexion from lying supine position with and without elastic band around feet for the resistance (exercises 6 & 7), hip and knee flexion toward the patient’s chin in lying supine position with patient’s legs on Swiss ball (exercise 8), shifting extended leg from Swiss ball on the therapy bed and vice versa in lying supine position (exercise 9), hip abduction with extended knee from side lying position (exercise 10), hip flexion and extension with knee extension from side lying position (exercise 11), knee flexion and extension from side lying position (exercise 12), knee extension from sitting position (exercise 13). Isometric exercise is performed in sets of 1, 5 repetitions with maximal effort 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 symmetrical 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 symmetrical 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 11 exercises for the range of motion and strength of the lower extremity muscles and include: standing heel raise (exercise 1), hip extension from standing position (exercise 2), semi-squats (exercise 3), hip flexion from standing position with the extended knee (exercise 4), hip and knee flexion from standing position (exercise 5), hip abduction from standing position (exercise 6), hip extension from standing position while holding the edge of the pool with hand (exercise 7), touching ipsilateral leg with the hand while the trunk is slightly bended forward (exercise 8), hip and knee flexion while floating on the water in supine position (exercise 9), hip abduction and adduction while floating on the water in supine position (exercise 10), and hip flexion with extended knee while simultaneously extending contralateral hip towards the bottom of the pool while floating in the water (exercise 11). Exercises are performed bilaterally.
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 blood 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).
Control group
Active

Outcomes
Primary outcome [1] 332245 0
Self-reported functional status of the hip using Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Timepoint [1] 332245 0
Day 1 of the rehabilitation, Day 21 of the rehabilitation.
Primary outcome [2] 332246 0
Quality of life using EQ-5D-5L questionnaire
Timepoint [2] 332246 0
Day 1 of the rehabilitation, Day 21 of the rehabilitation.
Primary outcome [3] 332247 0
Self-reported levels of pain using Numeric Rating Scale (NRS)
Timepoint [3] 332247 0
Day 1 of the rehabilitation, Day 21 of the rehabilitation.
Secondary outcome [1] 412690 0
Patient's functional status of the lower extremity using 30s Chair Stand Test
Timepoint [1] 412690 0
Day 1 of the rehabilitation, Day 21 of the rehabilitation.
Secondary outcome [2] 412691 0
Patient's mobility using Timed up & Go Test
Timepoint [2] 412691 0
Day 1 of the rehabilitation, Day 21 of the rehabilitation.
Secondary outcome [3] 413061 0
Primary outcome.
Quality of life using SF-36 Health Survey
Timepoint [3] 413061 0
Day 1 of the rehabilitation, Day 21 of the rehabilitation.

Eligibility
Key inclusion criteria
Patients admitted to inpatient postoperative rehabilitation after THA which consented to participate in the study.
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients after revision THA.
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.
Patients not able to follow standard rehabilitation protocol.

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
Not applicable
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
15/09/2022
Actual
Date of last participant enrolment
Anticipated
2/09/2023
Actual
Date of last data collection
Anticipated
23/09/2023
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 24938 0
Croatia
State/province [1] 24938 0

Funding & Sponsors
Funding source category [1] 312003 0
Hospital
Name [1] 312003 0
Bizovacke Toplice Rehabilitation Centre
Country [1] 312003 0
Croatia
Primary sponsor type
Individual
Name
Tomislav Kokic, MD
Address
Faculty of Medicine
University J. J. Strossmayer in Osijek,
31000 Osijek, Croatia
Country
Croatia
Secondary sponsor category [1] 313498 0
Individual
Name [1] 313498 0
Iva Sklempe Kokic, PhD
Address [1] 313498 0
Faculty of Kinesiology,
University J. J. Strossmayer in Osijek,
31000 Osijek, Croatia
Country [1] 313498 0
Croatia
Secondary sponsor category [2] 313499 0
Individual
Name [2] 313499 0
Matko Vuksanic, PT
Address [2] 313499 0

Bizovacke Toplice Rehabilitation Centre
Suncana 39
31222 Bizovac
Croatia
Country [2] 313499 0
Croatia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311425 0
Ethics commitee, Bizovacke Toplice Rehabilitation Centre
Ethics committee address [1] 311425 0
Ethics committee country [1] 311425 0
Croatia
Date submitted for ethics approval [1] 311425 0
08/07/2022
Approval date [1] 311425 0
28/07/2022
Ethics approval number [1] 311425 0
60/2022/I

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121050 0
Dr Tomislav Kokic
Address 121050 0
Faculty of Medicine, University J. J. Strossmayer in Osijek, J. Huttlera 4, 31000 Osijek, Croatia
Croatia
Country 121050 0
Croatia
Phone 121050 0
+385914435738
Fax 121050 0
Email 121050 0
[email protected]
Contact person for public queries
Name 121051 0
Iva Sklempe Kokic
Address 121051 0
Faculty of Kinesiology, University J. J. Strossmayer in Osijek, Drinska 16a, 31000 Osijek, Croatia
Country 121051 0
Croatia
Phone 121051 0
+385915082854
Fax 121051 0
Email 121051 0
[email protected]
Contact person for scientific queries
Name 121052 0
Iva Sklempe Kokic
Address 121052 0
Faculty of Kinesiology, University J. J. Strossmayer in Osijek, Drinska 16a, 31000 Osijek, Croatia
Country 121052 0
Croatia
Phone 121052 0
+385915082854
Fax 121052 0
Email 121052 0
[email protected]

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. Contact for the principal investigator is [email protected] .


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16866Study protocol  [email protected]
16867Statistical analysis plan  [email protected]
16868Informed consent form  [email protected]
16869Clinical study report  [email protected]
16870Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of Electromyographic Biofeedback-Assisted Exercise on Functional Recovery and Quality of Life in Patients after Total Hip Arthroplasty: A Randomized Controlled Trial.2023https://dx.doi.org/10.3390/jpm13121716
N.B. These documents automatically identified may not have been verified by the study sponsor.