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Flat Foot [Pes Planus] (Acquired), Unspecified FootNCT06313125

Comparison of Exercise Effects in Individuals With Flatfoot

A study testing 3-dimensional foot-ankle extension exercises, Clam exercise and Short-foot exercise in people with Flat Foot [Pes Planus] (Acquired), Unspecified Foot, run by Mustafa Kemal 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

Flexible flatfoot deformity, also known as flexible pes planus, is a common pathological condition characterized by decreased medial longitudinal arch height, eversion of the calcaneus and abduction of the forefoot, especially during loading. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
3-dimensional foot-ankle extension exercises, Clam exercise and Short-foot exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Feb 2024to 1 May 2024
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age range is 18-50 years
  • Navicular drop amount is 10 mm or more
  • Getting a value of +6 points or above from the Foot Posture Index

Who cannot join

  • Orthopedic and rheumatological diseases of the spinal region and lower extremities
  • Surgery history of the spine and lower extremities
  • Neurological and systemic disorders
  • Describing lower extremity and/or lower back pain in the last 6 months
  • Disorders that may affect cognitive and balance (otitis media, visual impairment, etc.)
  • Having received any physiotherapy and rehabilitation treatment for flat feet or hips in the last year
Show all 9Show fewer
  • Body mass index being above normal values (18-24.9 kg/m2)
  • Having rigid flat feet and hallux rigidus-limitus deformity
  • Doing regular sports or exercise

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

    Ankara, Çankaya, 06540

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Effects Three-Dimensional Foot-Ankle Exercise and Hip Abductor and External Rotator Strengthening Exercise With Flexible Flatfoot Individuals: Randomized Controlled Study

Flexible flatfoot deformity, also known as flexible pes planus, is a common pathological condition characterized by decreased medial longitudinal arch height, eversion of the calcaneus and abduction of the forefoot, especially during loading. Conservative treatments are generally considered as the first step in treatment. In conservative treatments, exercise methods are one of the most frequently used interventions. It has been reported that exercise can improve functional outcomes such as navicular drop, plantar pressure distribution, foot posture, balance, and muscle strength in adults with flexible flatfoot. Although it is known that intrinsic muscle strengthening exercises are a frequently used intervention method in foot pathologies, there is a deficiency in the literature regarding studies investigating the effect of the combination of the most basic foot intrinsic muscle strengthening exercises with different exercise interventions on targeted clinical gains. However, the effect of three-dimensional foot-ankle exercise on flat feet is unknown. Additionally, there are a limited number of studies in the literature investigating the effects of hip abductor and external rotator muscle strength training on foot posture in individuals with flat feet. The aim of this thesis study, planned in the light of this information, is to determine the effects of three-dimensional foot-ankle extension exercises and hip abductor-external rotator muscle strengthening exercise primarily on navicular drop and MLA height in individuals with flexible flat feet; Secondly, it is to examine and compare the effects of static foot posture, hip abductor/external rotator, ankle circumference and intrinsic muscle strength on the functional performance of the lower extremity (endurance, dynamic balance and single leg forward jumping performance). To our knowledge, this study will be the first randomized controlled study to examine and compare the effects of two different exercise interventions that exercise the proximal and distal regions in flatfoot rehabilitation, and the results obtained will contribute to the development of better exercise and treatment programs in this population. In individuals with flat feet, when hip abductor/external rotator strengthening exercises or 3D foot-ankle extension exercises in the PNF pattern are added to short-foot exercise, MLA structure, muscle strength and lower extremity function will be improved more, and when these exercises are combined with short-foot exercise, they are comparable to intrinsic muscle strengthening exercises alone. The investigators hypothesized that it would produce superior clinical results.

Read the detailed description

This study was designed as an experimental, 3-arm, parallel group, single-blind randomized controlled study that included a 6-week intervention period. The study will be carried out in the university physiotherapy and exercise laboratory. Flat-footed individuals aged between 18-50 years will be included in this study. G-Power (Windows version 3.1.9.7) statistical program was used to determine the number of participants. Sample size calculation was made based on a similar study in the literature that evaluated the amount of navicular drop after foot intrinsic muscle strength training (the primary outcome measure of this study). Type 1 error probability 0.01; The power was accepted as 0.90 and the number of samples was determined as at least 15 people for each group. By adding the 20% loss rate to this number, it was decided that the required number of participants would be 20 people in total for each group. Participants who were confirmed to be included in the study were evaluated by the lead investigator, who was not involved in the evaluations, using Random Allocation Software (version 2.0) in a single block format, 3-dimensional foot-ankle exercise group (foot muscle exercise group, AEG), hip abductor and external rotator strengthening exercise. will be allocated to three different groups: group (hip muscles exercise group, KEG) and control group (CG). The investigator performing the assessments will be blinded to group allocation. Recording of groups' demographic information and assessment of outcome measures will be performed by a secondary investigative physical therapist who is blinded to group information. The principal investigator physiotherapist will be responsible for training the participants to perform the exercises assigned to them, communicating with the participants to monitor exercise performance and exercise compliance, allocating the groups and ensuring blinding. Outcome measurements will be repeated at the start of treatment and at the end of treatment.

Being tested
3-dimensional foot-ankle extension exercises, Clam exercise, Short-foot exercise

What participants receive

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

  • 3-dimensional foot-ankle extension exercisesOther

    Also called Short-foot exercise

    In three-dimensional foot-ankle extension exercises, an elastic band will be used to create resistance to the movement and the intensity/severity of the exercise will be between 13 (somewhat difficult) and 15 (difficult) according to the perceived difficulty level on the Borg scale. Exercises will begin with red (light) tape; Progression will be achieved by moving to a higher level band color [green (medium) and blue (difficult) in that order] every two weeks. Exercises will be performed 3 days a week (2 days supervised, 1 day at home), in 3 sets of 10 repetitions, and a 1-minute rest period will be given between sets to reduce fatigue. Short-foot exercises will be performed in 3 sets of 15 repetitions, with a 45-second rest period between sets, every day a week (2 days/week with a physiotherapist; 5 days/week at home) for 6 weeks.

  • Clam exerciseOther

    Also called Short-foot exercise

    In three-dimensional foot-ankle extension exercises and clam exercise, an elastic band will be used to create resistance to the movement and the intensity/severity of the exercise will be between 13 (somewhat difficult) and 15 (difficult) according to the perceived difficulty level on the Borg scale. Exercises will begin with red (light) tape; Progression will be achieved by moving to a higher level band color [green (medium) and blue (difficult) in that order] every two weeks. Exercises will be performed 3 days a week (2 days supervised, 1 day at home), in 3 sets of 10 repetitions, and a 1-minute rest period will be given between sets to reduce fatigue. Short-foot exercises will be performed in 3 sets of 15 repetitions, with a 45-second rest period between sets, every day a week (2 days/week with a physiotherapist; 5 days/week at home) for 6 weeks.

  • Short-foot exerciseOther

    In clam exercise, an elastic band will be used to create resistance to the movement and the intensity/severity of the exercise will be between 13 (somewhat difficult) and 15 (difficult) according to the perceived difficulty level on the Borg scale. Exercises will begin with red (light) tape; Progression will be achieved by moving to a higher level band color [green (medium) and blue (difficult) in that order] every two weeks. Exercises will be performed 3 days a week (2 days supervised, 1 day at home), in 3 sets of 10 repetitions, and a 1-minute rest period will be given between sets to reduce fatigue. Short-foot exercises will be performed in 3 sets of 15 repetitions, with a 45-second rest period between sets, every day a week (2 days/week with a physiotherapist; 5 days/week at home) for 6 weeks.

Study groups in NCT06313125
Study groupRoleWhat they receive
Foot-ankle exercise groupExperimentalIn the foot-ankle exercise group, three-dimensional foot-ankle extension exercises will be applied in the Proprioceptive Neuromuscular Facilitation (PNF) pattern, in diagonal 1 and 2 directions and short-foot exercise.
Receives: Other: 3-dimensional foot-ankle extension exercises; Other: Short-foot exercise
Hip exercise groupActive comparatorClam exercise will be given to this group as a hip abductor and external rotator strengthening exercise. In addition, short-foot exercise will be applied.
Receives: Other: Clam exercise; Other: Short-foot exercise
Control groupActive comparatorThe control group will do only short-foot exercise.
Receives: Other: Short-foot exercise

What is being measured

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

  1. Medial longitudinal arch height-Navicular Drop Test

    To detect flatfoot MLA height will be evaluated by the Navicular Drop Test. According to this test result, if the MLA height is between 5-9 mm, the foot is in neutral position; If it is 4 mm or lower, the foot is in supination; If the value is 10 mm or more, a classification can be made as the foot is in pronation. This result will also be used when determining the inclusion criteria, and values of 10 mm and above will be interpreted as low arc.

    Measured: 6 weeks

Secondary outcomes (3)
  1. Static foot posture-Foot Posture Index-6

    Static foot posture will be evaluated by the Foot Posture Index-6 survey. While the participant is standing in a comfortable position, first the talus head will be palpated, then the foot will be observed from 3 directions and the remaining items will be evaluated.

    Measured: 6 weeks

  2. Foot structure-Photopodometric analysis

    Photopodoscopic analysis will be performed with a podoscope device and the Clarke's angle and the Staheli index will be calculated to decide on pronation or supination. The Wejsflog index, hallux valgus angle (ALPHA), and the angle of the varus deformity of the fifth toe (BETA) will be obtained by photophodometer analysis method to detect changes in foot structure. For this, a podoscope (Podo4Foot® CAM) and a special software program (Multireha® software, KOORDYNACJA AS, Radom, Poland) will be used.

    Measured: 6 weeks

  3. Recording demographic and clinical information on the evaluation form

    Participants' age (years), gender (female/male), body weight (kg), height (cm), body mass index (kg/m2), dominant side lower extremity (right/left), regular sports habits, injury/surgical history and back or lower extremity complaints will be recorded in the evaluation form prepared by the research administrators. Participants will be asked with which foot they kick the ball, and the foot with which the ball is kicked will be considered the dominant lower extremity.

    Measured: 1 week

Timeline

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

  1. First posted15 Mar 2024
  2. Study start21 Feb 2024
  3. Primary completion31 Mar 2024
  4. Study completion1 May 2024

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There will be three groups in the study. Short-foot exercise for the control group; short-foot and 3-dimensional foot-ankle exercise for the foot-ankle group; short-foot and clam exercise will be applied for the hip group.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06313125
Sponsor's protocol ID
E-77082166-302.08.01-796166
Status last verified
May 2024
First submitted
2 Mar 2024
Last updated
3 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Huang C, Chen LY, Liao YH, Masodsai K, Lin YY. Effects of the Short-Foot Exercise on Foot Alignment and Muscle Hypertrophy in Flatfoot Individuals: A Meta-Analysis. Int J Environ Res Public Health. 2022 Sep 22;19(19):11994. doi: 10.3390/ijerph191911994.

    PubMed 36231295
  • 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
  • Engkananuwat P, Kanlayanaphotporn R. Gluteus medius muscle strengthening exercise effects on medial longitudinal arch height in individuals with flexible flatfoot: a randomized controlled trial. J Exerc Rehabil. 2023 Feb 23;19(1):57-66. doi: 10.12965/jer.2244572.286. eCollection 2023 Feb.

    PubMed 36910682
  • 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
  • Esen DH, Duman T, Tas S, Karatas N. Three-dimensional foot-ankle exercise versus clam exercise in addition to short-foot exercise in individuals with flexible flatfoot: a randomized controlled trial. Physiother Theory Pract. 2025 Oct;41(10):2043-2054. doi: 10.1080/09593985.2025.2492166. Epub 2025 Apr 17.

    PubMed 40244701

Questions about this trial

What is this clinical trial studying?

A study testing 3-dimensional foot-ankle extension exercises, Clam exercise and Short-foot exercise in people with Flat Foot [Pes Planus] (Acquired), Unspecified Foot, run by Mustafa Kemal 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 3 inclusion and 9 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 3 Jun 2024. 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?

Medial longitudinal arch height-Navicular Drop Test (time frame: 6 weeks). 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 NCT06313125, which also lists 5 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 3 Jun 2024.

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