Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03363074 |
| Other study ID # |
ETK00-2017-0204 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 20, 2017 |
| Est. completion date |
September 5, 2018 |
Study information
| Verified date |
November 2018 |
| Source |
Eastern Mediterranean University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to compare low-level laser therapy and insole interventions on
pain, function and muscle strength in subjects with posterior tendon insufficiency.
Description:
Purpose of the research; stage 1-2 tibialis between the ages of 18-60 is a comparison of
low-level laser therapy and orthotic insole on pain, function and muscle strength in subjects
with posterior tendon insufficiency.
Type of research:
This study is a randomized comparative intervention study.
Place to do research:
The study will be carried out in the Prosthetic Orthotics and Biomechanics Center of the
Department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of the
Eastern Mediterranean University.
Evoluotion and Sample Size Of Research:
Subjects aged 18-60 who volunteered by the physician from Eastern Mediterranean University
who had been diagnosed with tibialis posterior insufficiency would be included in the
study.According to the power analysis using G-Power program; a total of 52 subjects will be
included in the calculation of Cohen d = 0.8, α = 0.05, β = 0.20, assuming that the
nonparametric Mann Whitney-U test is used for comparison between the two groups. It was
decided that 60 people would be taken from the survey without a 20% loss.
Volunteers Including / Exploring Criteria:
Inclusion Criteria:
- Taking the diagnosis of stage 1 - 2 tibialis posterior insufficiency by the physician,
- Be between the ages of 18 and 60,
- The absence of a different orthopedic or neurological disease that may affect the lower
extremity biomechanics,
- Not having a systemic disease that keeps feet. Having not received any treatment from
the foot area in the last 1 year.
Exclusion Criteria:
- Having lower extremity discrepancy more than 1 centimeter (cm),
- Having no ambulation without help.
Reserch Method:
Our study consists of two groups and the subjects will be taken to these groups using a
random number table. One group of our study is a and orthotic insole group and the other
group is a low -level laser therapy group. The orthotic insole group will use their special
insoles for 8 weeks. The low-level laser therapy group will receive treatment at the
Prosthesis Orthotic Biomechanics Center of the Eastern Mediterranean University three times a
week for 5 weeks. Laser will be applied along the tibial posterior tendon. Before the data is
collected, the individual will be informed about the equipment to be used in the tests. There
will be 1 trial before assessment and treatment so that participants can become familiar with
the equipment. All assessments and insoles will be applied by the same physiotherapist.
Data Collection Vehicles and Properties:
To be applied to the patient:
1.Pain Assessment ; with digital algometer 2.Muscle strength assessment ; with Isokinetic
Dynamometer 3.Evulation of Foot Function ; with Foot Function Index 4.Other Assessment ; Foot
Posture Index, International Physical Activity Index(short form)
1. Pain Assessment ; It will be assessed with pain algometer. Before starting treatment,
measurements will be taken at three different points of the tibialis posterior tendon.
Three measurements from each point will be taken. The right and left foot will be
evaluated. the previously assessed regions will be reevaluated at the end of the
treatment.
2. Muscle strength assessment Using the isokinetic dynamometer (Humac Norm Isocynetic
Dynanometer), the force values of the inverter and the evertor muscles of the foot will
be measured.Before starting the test, a standard warm-up program will be applied for 3
minutes without resistance in the patient bicycle ergometer. At the same time, passive
stretching of the patients' gastrocnemius and soleus muscles. Subjects movements will be
evaluated at 10 repetitions at 180º / sec, 10 repetitions at a rate of 240º / sec.
Before each angular velocity, subjects are allowed to perform 3 repeated trials and
after 10 seconds rest, tests will be applied. Unilateral measurement will be performed.
3. Evulation of Foot Function ; with Foot Function Index. This scale evaluates the severity
of foot pain in different situations. It consists of 3 subtitles and contains 23
questions in total. Turkish version adaptation study is done, valid and reliable
measure. Each question takes between 0 and 10 points. the total score is divided by the
number of questions answered and scaled by finding the value over 100.
4. Other Assessment;
1. Foot Postüre Index : Index will be used to determine the flat foot of the
individuals. According to the scale, a total score of -12 to +12 is obtain with a
score under six headings during static standing. Medial longitudinal arch height
increases with increasing points, medial longitudinal height decreases with
increasing points. Our study will include individuals who have received a minimum
score of +6 as in similar research.
2. International Physical Activity Index (short form) (IPAQ) : The index will be used
to determine the physical activity levels of individuals. With the scale of Turkish
validity and reliability studies, low, medium and high intensity activity periods
of the individuals in the last week will be evaluated under 7 questions and the
average energy expenditure value will be obtained in kcal / week.Individuals will
be asked to do this questionnaire on a regular basis every week.
Treatment Program:
Low-level Laser Therapy Group; A low density laser with a power density of 0.05-0.10 (w /
cm2), a therapeutic dose of 0.7-7 (j / cm 2) of gallium-arsenic 904 nm will be applied. It
will be administered 3 times a week for 5 weeks. Laser treatment will be applied along the
tibialis posterior tendon. 3 different point applications will be done. Proximal tibial
tendon, distally tibial tendon and medial malleoli posterior.
Orthotic Insole Group:
Individuals will be operated by pressing on a fixed pedobarograph (Medilogic, platform basic,
Germany) embedded in a 5-m wooden floor and foot pressure measurements will be taken. Of the
three successful measurements made, the one closest to the normal walk will be recorded.
According to the foot pressure measurement, the MLA, TA and MTK attachments will be used in
the insoles design developed by the modeling program.
The individual will use the insoles for 8 weeks with the appropriate footwear. individuals
will be required to fill in the international physical activity scale each week. As well as
how many hours a day each of his or her inviduals have been using their insoles. A table will
be created and given to the individuals to write how many hours they are using.
