- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05128526
Short Foot Exercises With Respiratuar Exercises
Effect of Respiratory Combined Short Foot Exercises on Foot and Ankle Muscle Activity in Individuals With Pes Planus
Study Overview
Status
Intervention / Treatment
Detailed Description
Ten volunteer individuals with flat feet, studying at the Faculty of Health Sciences, will be included in the study. The feet of the individuals who want to be included in the study will be examined by the researchers with the Navicular drop test. Individuals' age, height, weight, gender, shoe size will be questioned. Flat feet of individuals will be determined by the Navicular Drop test. The navicular drop test is a test used to measure the amount of pronation in the foot, which is obtained by subtracting the navicular height measured while standing with weight on the foot, from the navicular height measured in the sitting position without placing weight on the foot. While individuals are sitting on a chair with bare feet, the navicular tubercle will be marked on both feet and marked at the level of the navicular tubercle on a card on the floor. Afterward, the individual was asked to stand up, and the navicular tubercle alignment would be re-marked on the same card while giving full weight to the foot. The expression in mm of the distance between both lines will be recorded as the amount of navicular drop. The amount of navicular drop between 6 and 9 mm will be considered as normal Medial Longitudinal Arch, and if it is 10 mm or more, it will be considered as pes planus. Individuals will be divided into two groups according to the Navicular drop test. This research will consist of two groups, one group of individuals with flat feet and one group of individuals without flat feet. In both groups, foot shortening exercises will be applied in two different situations. The first case is the activation of the foot circumference muscles during the foot shortening exercises, and the second situation is the activation of the foot circumference muscles during the combination of the foot shortening exercises with the breathing exercises. Foot shortening exercise, in this exercise that works the small intrinsic muscles of the foot in isolation, the subjects will be asked to raise the medial foot and hold it in this position for 5 seconds while sitting on the ground with the feet in the subtalar neutral position, trying to bring the heel and fingers closer to each other. During the movement, the fingers will be warned not to bend participants' fingers to avoid a contraction in the long flexor muscles, while Participants will be asked to do 3 repetitions. After the individuals are given 5 minutes to rest the participants' feet, participants will be asked to combine the same exercise with breathing exercises. When the exercise is terminated, the situation will be returned to the start position. Muscular activations of the Tibialis anterior, Abductor Hallucis, and Peroneus Longus muscles will be measured with superficial kinesiological electromyography (EMG) device. The electrode sites will be prepared for the EMG signal by shaving and cleaning the skin with cotton dipped in alcohol to minimize output impedance and allow proper electrode bonding. Disposable Ag/AgCl superficial electrodes will be placed approximately 2 cm apart in the direction of the muscle fibers. Electrodes will be placed parallel to the muscle fibers at points recommended by Surface ElectroMyoGraphy for the Non-Invasive Assessments of Muscles (SENIAM). A detailed description of the electrode placements is as follows:
EMG electrodes for Abductor Hallucis will be attached from the anterior edge of the medial malleolus approximately 1-2 cm posterior to the navicular tuberosity, located just in front of the vertical line. For the Tibialis Anterior, the electrodes will be placed in the area corresponding to the one-third between the tip of the head of the fibula and the medial malleolus. For the Peroneus Longus muscle, the electrodes will be placed at 25% of the distance between the tip of the head of the fibula and the tip of the lateral malleolus.
In order to measure the maximum voluntary contraction values from the determined muscle groups, separate EMG measurements will be performed with 3 repetitions of maximal contraction of 5 seconds, with a resting period of 30 seconds between each of them. As a result of these measurements, the average of these 3 repetitions performed at the maximum activation level for each muscle of the individuals will be taken. Afterward, surface EMG measurements will be taken from the same muscle groups for 10 seconds during the foot shortening exercises while breathing and without breathing. According to the maximum voluntary contraction for each muscle, the muscle activation rates will be determined during the foot shortening exercises with and without breathing [activity muscle activation amount / Maximal voluntary contraction * 100 (% Maximum voluntary contraction)]. The sampling rate of the EMG signal will be set to 1000 Hz. A 20 Hz Butterworth High-Pass filter will be applied to all EMG recordings and RMS 100 ms will be selected and filtered for smoothing. Measured data will be analyzed using Noraxon MyoResearch XP software (version 1.08; Noraxon Inc, Scottsdale, AZ).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06018
- Tezel Yıldırım Şahan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age between 18-25 years
- having bilateral pes planus according to Navicular Drop Test
Exclusion Criteria:
- were having rigid pes planus, hallux valgus, hallux rigidus, epin calcanei, systemic, neurological, or orthopedic problems that can affect the lower extremity
- inflammatory arthritis; foot ankle surgery; diabetes; or toe deformities, such as claw toe, or hammertoe,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Short foot exercise without respiratory exercises
The participant will place by the researcher in the standing position so that the width between both feet will equal the width of the pelvis and the second toe will align with the patella. During the Short Foot Exercise, the participant will ask to position the spine straight, maintain the pelvis in a neutral position, and place the centerline of the body. The starting position will be set by the researcher under the same conditions as the midway between the feet. The subjects will give feedback from the researchers to assist in the maintenance of accurate body alignment. SFE, only in a standing position. The participants will keep in contact with the fibular head of the target bar to maintain a constant position during Short Foot Exercises. Afterward, surface EMG measurements will be taken from the same muscle groups for 10 seconds during the foot shortening exercises while without breathing. |
Short foot exercises without respiratory exercises
Other Names:
|
|
Experimental: Short Foot Exercise With Respiratory Exercise
The participants will keep in contact with the fibular head of the target bar to maintain a constant position during Short Foot Exercises.
Afterward, surface EMG measurements will be taken from the same muscle groups for 10 seconds during the foot shortening exercises while with breathing.
|
Short foot exercises with respiratory exercises
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of the activity of the Abductor Hallucis Longus, Tibialis Anterior or, Peroneus Longus
Time Frame: 30 min
|
Muscle activity will be measured by surface electromyography.
Measurment of activity will be done in three condition.
Firstly maximum contraction, secondly on standing condition maximum contraction muscle activity will be measured.
Last condition is on standing with restiratory exercises maximum contraction of muscles will be measured.
Consequently all parameters will be compared.
|
30 min
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tezel Şahan, pHD, University of Health Science
Publications and helpful links
General Publications
- Choi JH, Cynn HS, Yi CH, Yoon TL, Baik SM. Effect of Isometric Hip Abduction on Foot and Ankle Muscle Activity and Medial Longitudinal Arch During Short-Foot Exercise in Individuals With Pes Planus. J Sport Rehabil. 2020 Jul 27;30(3):368-374. doi: 10.1123/jsr.2019-0310.
- Unver B, Erdem EU, Akbas E. Effects of Short-Foot Exercises on Foot Posture, Pain, Disability, and Plantar Pressure in Pes Planus. J Sport Rehabil. 2019 Oct 18;29(4):436-440. doi: 10.1123/jsr.2018-0363. Print 2020 May 1.
- Jung DY, Koh EK, Kwon OY. Effect of foot orthoses and short-foot exercise on the cross-sectional area of the abductor hallucis muscle in subjects with pes planus: a randomized controlled trial. J Back Musculoskelet Rehabil. 2011;24(4):225-31. doi: 10.3233/BMR-2011-0299.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/366
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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