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ExerciseNCT05128526

Short Foot Exercises With Respiratuar Exercises

A study testing exercise and respiratory in people with Exercise and Flatfoot, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pes planus is a common foot problem since childhood, which may include loss of height of the medial longitudinal arch, which is the most important arch supporting the foot, valgus of the hindfoot, and abduction of the midfoot relative to the hindfoot. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Exercise, Flatfoot
What is being tested?
exercise and respiratory
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Oct 2021to 20 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • age between 18-25 years
  • having bilateral pes planus according to Navicular Drop Test

Who cannot join

  • 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,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Tezel Yıldırım Şahan

    Ankara, 06018

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Respiratory Combined Short Foot Exercises on Foot and Ankle Muscle Activity in Individuals With Pes Planus

Pes planus is a common foot problem since childhood, which may include loss of height of the medial longitudinal arch, which is the most important arch supporting the foot, valgus of the hindfoot, and abduction of the midfoot relative to the hindfoot. Muscle shortness, increased joint laxity with obesity, W-shaped sitting, male gender and genetic background are among the factors that can increase the incidence and severity of pes planus in the pediatric population. It has been shown in different studies that pes planus is carried into adulthood at a rate of 4-23%. It is known that there is oxygen consumption from the body during muscle contraction. For this reason, it has been shown in the literature that muscle oxygenation is better and the performance of the individual is better in exercises combined with breathing exercises in the exercise program. Therefore, the investigators hypothesized whether foot shortening exercises combined with breathing would have an effect on muscular activation during foot shortening exercises. It is seen that there is a limited number of studies in the literature evaluating the effect of breathing exercises and combined foot exercises on the activation of the muscles around the feet. For this reason, the aim of this study is to examine the effect of combined respiratory foot shortening exercises on the muscular activations of the foot circumference in individuals with flat feet. Two-way repeated analyses of variance will use to determine the statistical significance of Abductor Hallucis Longus, Tibialis Anterior, and Peroneus Longus electromyography activity. Participants: Ten participants with pes planus.The participants will perform Short Foot Exercises with and without respiratory exercises in sitting and standing positions. Main Outcome Measures: Surface electromyography will use to measure the activity of the Abductor Hallucis Longus, Tibialis anterior, Peroneus Longus. Respiratory exercises may be an effective method for reducing compensatory Tibialis Anterior activity and increasing Abductor Hallucis Longus muscle activity during Short Foot Exercises for individuals with pes planus.

Read the 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).

Conditions
Exercise, Flatfoot
Being tested
exercise, respiratory
Keywords
pes planus, respiratory, exercise, short foot exercise
Medical subject headings
Motor Activity, Flatfoot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exerciseBehavioural

    Also called short foot exercise

    Short foot exercises without respiratory exercises

  • respiratoryBehavioural

    Also called Short foot exercise

    Short foot exercises with respiratory exercises

Study groups in NCT05128526
Study groupRoleWhat they receive
Short foot exercise without respiratory exercisesExperimentalThe 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.
Receives: Behavioral: exercise
Short Foot Exercise With Respiratory ExerciseExperimentalThe 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.
Receives: Behavioral: respiratory

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of the activity of the Abductor Hallucis Longus, Tibialis Anterior or, Peroneus Longus

    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.

    Measured: 30 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2021
  2. Study start5 Oct 2021
  3. Primary completion10 Dec 2021
  4. Study completion20 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
Two-way repeated analyses of variance were used to determine the statistical significance of muscles electromyography activity
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128526
Sponsor's protocol ID
2021/366
Status last verified
Nov 2022
First submitted
28 Oct 2021
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32717719
  • 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.

    PubMed 30860412
  • 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.

    PubMed 22142711

Questions about this trial

What is this clinical trial studying?

A study testing exercise and respiratory in people with Exercise and Flatfoot, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of the activity of the Abductor Hallucis Longus, Tibialis Anterior or, Peroneus Longus (time frame: 30 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05128526, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.

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