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Trial registered on ANZCTR


Registration number
ACTRN12616001416482
Ethics application status
Approved
Date submitted
20/09/2016
Date registered
11/10/2016
Date last updated
24/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Application of High Tone Power Therapy in patients after Anterior Cruciate Ligament reconstruction
Scientific title
Application of High Tone Power Therapy in restoring quadriceps muscle strength in patients after Anterior Cruciate Ligament reconstruction
Secondary ID [1] 290177 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament reconstruction 300317 0
Condition category
Condition code
Musculoskeletal 300183 300183 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 300319 300319 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Persons qualified for the research are patients of the Clinic of Orthopaedics and Rehabilitation, University Hospital in Krakow, who will undergo ACL reconstruction.
After the surgery, the patients will be randomly divided into two groups. The first group will have the HiToP included in rehabilitation (HiToP), while the second will be treated without the HiToP (nHiToP).
Division of patients into the experimental and control group is decided upon the coin-tossing during first examination. Heads – HiToP group, tails – nHiToP group

Research methods
The study will include measurements of maximum muscle torque of the quadriceps and ROM, evaluation of knee function and pain assessment. The examination will be carried out twice.
The first examination session wll take place a 2 days prior to the surgery. For each patient measurements of the maximum muscle torque will be performed in standard positions for the measurement of the knee extensors strength (angles between the trunk, hip joint and knee joint were 90 degrees). The examination will be conducted by means of the Isometric muscle force measurement. The value of maximum muscle force (Fmax) was measured and on its basis the values of maximum muscle torque (tmax) and relative muscle torque (tr) for a selected group of muscles were calculated according to]:
tmax = Fma x d [Nm]
tr = tmax/m [Nm/kg]
where: d — the value of the external force arm- the distance from the axis of joint rotation to the line of action of the dynamometer, m—weight of the subject.
Next, the ROM measurements in both legs by means of a goniometer and measurement of the circumferences of the thigh (10 centimetres from the base of the patella) and the knee. Moreover, the knee function assessment with the use of the Lysholm scale will be performed as well as the visual-analog (VAS) pain assessment scale
In the period from 1 to 10 day after the surgery the patientswill be complied with the physician’s recommendations: the knee is protected in orthosis in full extension, swelling prevention is applied as well as cooling the joint with cold compresses. Next patients will started intensive physiotherapy. During the first 3 months therapy will be carried out 3 times a week, while between 4th and 6th month – twice a week. The duration of each session is 60 minutes and it is individual one-on-one sessions at the gym. Ech sesion is supervise by physiotherapist.
Physiotherapy includes general rehabilitation and exercises focused on the knee function. The exercise protocol includes:
1 exercises improving the ROM,
2 strengthening the muscles of the operated limb,
3. proprioception exercises
4. coordination exercises with the use of accessories, i.e. TheraBand strip.
The goals of the individual stages of physiotherapy
1-10 days after the surgery
1 Pain and swelling control
2 Early range of motion exercises
3 Achieving and maintaining full extension of the joint
4 Gait training
11-21 days after the surgery
1 Maintaining full extension
2 Achieving 100 – 120 degrees of flexion
3 Gradual weaning of the orthosis
4 Pain and swelling control
5 Improvement in proprioception
3-5 weeks after the surgery
1 Achieving full range of motion – until 6th week- full extension, and at least 135 degrees of flexion
2 Restoration of muscle strength
6-12 weeks after the surgery
1 The range of flexion minimum 135 degrees
2 Continuation of the strength training
12-20 weeks after the surgery
1 Continuation of the strength training
2 Start of running and agility training
from 6th month after the surgery
1 A gradual return to sport activity

After each stage patient has has carried out the range of motion examination and muscle strength testing as well as measurement of the circumference of the knee to assess the swelling.

After the surgery, the patients will be randomly divided into two groups. The first group will have the HiToP included in rehabilitation (HiToP), while the second will be treated without the HiToP (nHiToP).
Division of patients into the experimental and control group is decided upon the coin-tossing during first examination. Heads – HiToP group, tails – nHiToP group

Patients from HiToP Group will be also applied HiToP. High HiToP treatment involved electro stimulation of the quadriceps muscle at a frequency of 20 Hz (two electrodes set in the place of transition of muscle bellies into a tendon) and vitalisation: electrodes will be arranged on the feet, forearms and the cervical spine using simultaneous frequency and amplitude sweep (in the range from 4096 to 32768 Hz) which purpose will be to trigger and use in the therapy non stimulating effects of the currents.
HiToP is performed at physiotherapy sessions and the duration of administration is 1 hour. 60 minute of HiToP session will take place after the completion of 60 minutes of physiotherapy. The total duration of intervention in patients from the research group will be 2 hours.
After 6 months muscle strength and ROM measurements, assessment of pain and knee function will be repeated.

Patients who signed consent to participate in research also committed to abide by the presence of physiotherapy sessions. It is permissible absence for two sessions in the rehabilitation program. Exceeding this number results in exclusion from further physiotherapy. Any presence is recorded in the patient documentation.
Intervention code [1] 295935 0
Rehabilitation
Intervention code [2] 296001 0
Treatment: Devices
Comparator / control treatment
The control group will have the same rehabilitation program as research group but without High Tone Therapy.
Control group
Active

Outcomes
Primary outcome [1] 299669 0
Proportion of participants with an increase in strength of quadriceps muscle. Muscle force assessed by dynamometer
Timepoint [1] 299669 0
at the end of six-months rehabilitation
Primary outcome [2] 299670 0
Proportion of participants with a decrease in pain according to the VAS scale.
Timepoint [2] 299670 0
at the end of six-months rehabilitation
Primary outcome [3] 299749 0
Proportion of participants with an increase in range of motion of knee according to goniometric measurements.
Timepoint [3] 299749 0
at the end of six-months rehabilitation
Secondary outcome [1] 327779 0
Knee function, assessed using the Lysholm scale.
Timepoint [1] 327779 0
at the end of six-months reghabilitation

Eligibility
Key inclusion criteria
Eligibility criteria for the research are::
1. The form of treatment prescribed by a doctor – cruciate ligament reconstruction by an autogenic method – ST tendon graft
2. Ability to move independently before and after the treatment (without the use of orthopedic supports)
3. No other injuries or illnesses that may affect the outcome of the tests (e.g. damage to the menisci, degenerative changes in the joints of the leg).
4. A voluntary consent of the patient to participate in the study.
5. The patients had not taken medications affecting motor coordination.
Minimum age
20 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria from the surgery and rehabilitation program:
1. Too frequent absence in the arranged training sessions (more than twice)
2. Interruption of continuity of the graft

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)
After the surgery, the patients will be randomly divided into two groups. The first group will have the HiToP included in rehabilitation (HiToP), while the second will be treated without the HiToP (nHiToP).
Division of patients into the experimental and control group is decided upon the coin-tossing during first examination. Heads – HiToP group, tails – nHiToP group

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be developed using Statistica 10 software. Methods of descriptive statistics will be used to present the results in the form of tables containing arithmetic means, standard deviation, minimum and maximum values.
General linear models (GLM) will be used in calculations. Analysis of variances will be conducted for repeated measurements and multiple comparisons with the Bonferroni correction to examine detailed differences between measurements in both Groups. The study adopted the level of significance p <0,05

Recruitment
Recruitment status
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] 8247 0
Poland
State/province [1] 8247 0
Malopolska

Funding & Sponsors
Funding source category [1] 294542 0
University
Name [1] 294542 0
University of Physical Education in Krakow
Address [1] 294542 0
Al. Jana Pawla II 78
31-571 Krakow
Country [1] 294542 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] 293413 0
None
Name [1] 293413 0
Address [1] 293413 0
Country [1] 293413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295980 0
Bioethics Commission at the Regional Medical Chamber in Krakow
Ethics committee address [1] 295980 0
ul. Krupnicza 11a
31-123 Krakow
Ethics committee country [1] 295980 0
Poland
Date submitted for ethics approval [1] 295980 0
02/04/2014
Approval date [1] 295980 0
08/04/2014
Ethics approval number [1] 295980 0
No. 19/KBL/OIL/2014

Summary
Brief summary
The aim of the research is to assess the effectiveness of electro stimulation of the quadriceps muscle in patients after anterior cruciate ligament (ACL) reconstruction, with the use of High Tone Power Therapy.
The research material comprised a Group of patients which will undergone ACL reconstruction surgery. Research tools will include the measurement of muscle strength torque, ROM measurment, evaluation of knee functions with the use of the Lysholm scale and the VAS pain scale. The tests will be carried prior to and 6 months following the anterior cruciate ligament reconstruction. After the treatment, the patients will be subjected to 6-month rehabilitation. and will be divided into two groups - the test research with HiTo therapy in rehabilitation program and a control group without HiTo therapy.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1120 1120 0 0

Contacts
Principal investigator
Name 69122 0
Dr Katarzyna Ogrodzka
Address 69122 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 69122 0
Poland
Phone 69122 0
+48126831065
Fax 69122 0
Email 69122 0
katarzyna.ogrodzka@awf.krakow.pl
Contact person for public queries
Name 69123 0
Dr Katarzyna Ogrodzka
Address 69123 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 69123 0
Poland
Phone 69123 0
+48126831065
Fax 69123 0
Email 69123 0
katarzyna.ogrodzka@awf.krakow.pl
Contact person for scientific queries
Name 69124 0
Dr Katarzyna Ogrodzka
Address 69124 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 69124 0
Poland
Phone 69124 0
+48126831065
Fax 69124 0
Email 69124 0
katarzyna.ogrodzka@awf.krakow.pl

No information has been provided regarding IPD availability
Summary results
No Results