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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001416482
• Date of registration: 11/10/2016
• Prospective Registration: No
• Primary sponsor: University of Physical Education in Krakow
• 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
• Date of first enrolment: 15/04/2015
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616001416482.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Poland

Contacts

• Name: Dr Katarzyna Ogrodzka

• Name: Dr Katarzyna Ogrodzka

Key inclusion & exclusion criteria

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.

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

Age minimum: 20 Years
Age maximum: 50 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Other muscular and skeletal disorders

Physical Medicine / Rehabilitation - Physiotherapy

Anterior cruciate ligament reconstruction;
Anterior cruciate ligament reconstruction

Intervention(s)

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

Primary Outcome(s)

Proportion of participants with an increase in strength of quadriceps muscle. Muscle force assessed by dynamometer[at the end of six-months rehabilitation]

Proportion of participants with a decrease in pain according to the VAS scale.[at the end of six-months rehabilitation]

Proportion of participants with an increase in range of motion of knee according to goniometric measurements.[at the end of six-months rehabilitation]

Secondary Outcome(s)

Knee function, assessed using the Lysholm scale.[at the end of six-months reghabilitation]

Secondary ID(s)

none

Source(s) of Monetary Support

University of Physical Education in Krakow

Ethics review

Status: Approved
Approval date:
Contact:

Bioethics Commission at the Regional Medical Chamber in Krakow