- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06025266
Investigation of the Effect of Foot Muscle Fatigue on the Foot Sole and Tendon Structural Properties
Investigation of the Acute Effect of Foot Extrinsic Muscle Fatigue on Viscoelastic Properties of the Plantar Fascia and Achilles Tendon
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Uskudar
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İstanbul, Uskudar, Turkey, 34862
- University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Agreeing to participate in the study voluntarily
- Being a healthy, sedentary male individual between the ages of 18 and 35
- Being in categories 1 and 2 according to the International Physical Activity Survey (UFAA)
- Having a normal Body Mass Index (BMI) (18.5 kg/m2 ≤ BMI ≤24.9 kg/m2)
- Having a neutral foot posture (<6 points in the Foot Posture Index)
Exclusion Criteria:
- Refusing to participate in the study or wanting to leave the study
- Having a history of previous surgery in the lower extremity
- Being diagnosed with a musculoskeletal disease
- Having any chronic disease (hypertension, diabetes, cardiovascular disease, osteoporosis, rheumatism, etc.)
- Having a skin lesion in the area to be measured
- Significant weakness in the lower extremity gross muscle test
- Any limitation in the normal range of motion of the lower extremity
- Having any deformity in the foot (pes planus, pes cavus, hallux valgus)
- Navicular drop distance ≥10 mm
- Limitation in the range of motion of the 1st metatarsophalangeal joint (hallux rigidus-limitus)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Unilateral Heel Raise
Muscle fatigue was created by exercise consisting of a combination of repetitive plantar flexion and dorsiflexion movements performed during the entire range of motion of the ankle at the frequency of movement determined by the metronome on one step.
|
MyotonPro™, a handheld, non-invasive and painless device, is used for non-invasive measurement of the biomechanical and viscoelastic properties of soft biological tissues such as superficial skeletal muscles, fascia, tendons and ligaments.
The properties of the structures can be measured from different regions during complete rest or contraction.
|
Experimental: Closed Chain Resisted Foot Adduction
The exercise was performed on the designed wooden assembly.
The device was used to maintain the neutral position of the subtalar joint, stabilize the lateral and medial malleoli, and prevent compensation with the knee and hip joints.
Individuals were seated with the knee flexed approximately 80 degrees and separated from the other extremity by the length of the forearm, and the contralateral knee was stabilized with the ipsilateral hand.
The foot was brought from the abduction position to the adduction position and the heel was not lifted from the ground throughout the movement.
The exercise was performed using a green elastic band.The movement was performed in sets of 50 concentric/eccentric contractions.
A rest period of 10 seconds was added between each set.
|
MyotonPro™, a handheld, non-invasive and painless device, is used for non-invasive measurement of the biomechanical and viscoelastic properties of soft biological tissues such as superficial skeletal muscles, fascia, tendons and ligaments.
The properties of the structures can be measured from different regions during complete rest or contraction.
|
Experimental: Combined Exercise
Unilateral Heel Raise and Closed Chain Resisted Foot Adduction exercises were performed sequentially.
|
MyotonPro™, a handheld, non-invasive and painless device, is used for non-invasive measurement of the biomechanical and viscoelastic properties of soft biological tissues such as superficial skeletal muscles, fascia, tendons and ligaments.
The properties of the structures can be measured from different regions during complete rest or contraction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomechanical and viscoelastic properties of tissue
Time Frame: 3 weeks
|
Biomechanical and viscoelastic properties of AT and PF were performed using MyotonPro™ (Myoton AS, Tallinn, Estonia) device.
Before and immediately after the application of the fatigue protocol, AT and PF measurements were made separately with the MyotonPro™ device.
The measurement points determined for AT and PF of individuals during rest were marked with a medical marker pen (16).
The measurement points of each person and their distances to the anatomical points were measured with the help of a tape measure and recorded in their files to find the same point again.
During the measurement, the probe of the device was adjusted to pulse once into the skin with a force of 0.4 N and for 15 ms.
During the test, the tip of the MyotonPro™ device was placed perpendicular to the marked area and gently pressed against the skin at a depth of 3 mm until the green light came on.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identifying the Dominant Foot
Time Frame: 1 day
|
The dominant foot was determined using the ball-kicking method. While the individual was standing, a ball was placed in the middle of both feet and the individual was asked to hit the ball with his foot. The extremity on which the individual hit the ball was accepted as dominant. The dominant foot was determined using the ball-kicking method. While the individual was standing, a ball was placed in the middle of both feet and the individual was asked to hit the ball with his foot. The extremity on which the individual hit the ball was accepted as dominant. |
1 day
|
Sit-Reach Test
Time Frame: 1 day
|
In particular, a sit-reach bench (Baseline®, Cooper Institute/YMCA, AAHPERD, New York, USA) was used to measure the flexibility of the lower back and hamstring muscles.
Subjects were asked to contact a standard sit-and-reach bench in a sitting position, with their backs against the wall and their knees in full extension, with the soles of their feet flat on the box.
Then, individuals were asked to reach forward as far as possible by pushing the device apparatus with their fingertips without lifting their knees, with their palms facing down.
Measurements were repeated 3 times and the average of the values was recorded.
|
1 day
|
Silfverskiold Test
Time Frame: 1 day
|
The muscle shortness assessment of the individuals regarding M. Gastrocnemius was performed on both ankles while in the supine position using the Silfverskiold method and universal goniometer.
While the knee joint was in full extension and 90° flexion, and the subtalar joint was in the neutral position, the dorsiflexion of the ankle was passively performed by the assessor, and the fixed arm of the universal goniometer was measured on the fibula shaft and the mobile arm was placed on the fifth metatarsal shaft.
The resulting angles were recorded in degrees.
|
1 day
|
Navicular Height
Time Frame: 1 day
|
The navicular height was defined as the distance of the navicular tubercle to the ground when the individual was standing in a relaxed position.
In our study; Subjects were asked to stand in a comfortable position for navicular height assessment.
The medial protrusion of the tuberosity of the navicular was detected and marked by palpation, and the distance between this point and the ground was measured using a millimetric ruler.
The result is recorded in millimeters
|
1 day
|
Navicular Drop Distance
Time Frame: 1 day
|
Before the measurement, the medial protrusion of the tuberosity of the navicular was detected and marked by palpation.
The height of the navicular tubercle was determined with the help of a millimetric ruler placed on the medial part of the foot while the individuals were sitting in a chair with the soles of their feet touching the ground and the hips and knees flexed to 90°.
Individuals were asked to stand up and the height of the navicular tubercle was determined again.
The amount of change was determined with the help of a ruler and recorded.
Each measurement was repeated 3 times and the average value was recorded in millimeters.
|
1 day
|
Evaluation of Foot Posture
Time Frame: 1 day
|
Foot Posture Index-6 was used to evaluate foot posture.
During the evaluation, the subjects were asked to stand in a way that was comfortable, without moving.
Test; It was performed by the physiotherapist based on observation and palpation while the individual was in a static and comfortable standing position.
The index consists of 6 items in total, 3 items in the forefoot and 3 items in the hindfoot.
In the study; Evaluations were made bilaterally based on observation and palpation from the posterior, medial, lateral and anterior aspects.
|
1 day
|
Physical Activity Level
Time Frame: 1 day
|
The physical activity level of the individuals was evaluated with the International Physical Activity Questionnaire (IPAQ)-Short Form.
This scale, whose short form consists of 7 items, provides information about the time spent during the activity by classifying the activity according to the differences in intensity level.
Total Physical Activity Score; The vigorous and moderate physical activity and walking times of the participants in the last 7 days were calculated with the formulas by multiplying the minutes, the number of days and the MET-minute score appropriate for the physical activity performed (MET (Metabolic Equivalent of Task)-min/week).
According to the questionnaire, physical activity levels are those who are not physically active (<600 MET-min/week), low physical activity level (600-3000 MET-min/week) and adequate physical activity level (beneficial for health) (> 3000 MET-min/week).
|
1 day
|
Evaluation of Fatigue
Time Frame: 3 weeks
|
The level of fatigue perceived by the individuals during the study was evaluated with the "Borg Fatigue Scale" immediately after completing the fatigue protocol exercises.
Developed by Borg, this scale has 10 levels in its modified form, and the category ratio scale consists of definitions corresponding to certain numbers.
The participant was asked to score the perceived fatigue between 0 (not at all) and 10 (very very hard).
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Simge Dönmez, Kütahya Health Sciences University
- Principal Investigator: Fatmagül Varol, Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-959
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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