RecruitingACTRN12616001416482

Application of High Tone Power Therapy in patients after Anterior Cruciate Ligament reconstruction

Application of High Tone Power Therapy in restoring quadriceps muscle strength in patients after Anterior Cruciate Ligament reconstruction


Sponsor

University of Physical Education in Krakow

Enrollment

50 participants

Start Date

Apr 15, 2015

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether High Tone Power Therapy — a type of electrical muscle stimulation — can help people recover more effectively after surgery to reconstruct a torn anterior cruciate ligament (ACL) in the knee. Participants will go through a 6-month rehabilitation program after surgery, with some receiving the electrical stimulation treatment and others following standard rehab. Researchers will measure muscle strength, knee movement, and pain levels. You may be eligible if: - You are between 20 and 50 years old - You are scheduled for ACL reconstruction surgery using an ST tendon graft - You can move independently before and after surgery - You have no other significant injuries or joint problems in the same leg - You are not taking medications that affect motor coordination You may NOT be eligible if: - You miss more than two scheduled rehabilitation sessions - The surgical graft does not remain intact during recovery Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

Malopolska, Poland

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ACTRN12616001416482


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