Comparison of Exercise Effects in Individuals With Flatfoot

May 31, 2024 updated by: Dilek Hande Esen, Mustafa Kemal University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06540
        • Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Foot-ankle exercise group
In 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.
Other: 3-dimensional foot-ankle extension exercises
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.
Other Names:
  • Short-foot exercise
Other: Short-foot exercise
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.
Active Comparator: Hip exercise group
Clam exercise will be given to this group as a hip abductor and external rotator strengthening exercise. In addition, short-foot exercise will be applied.
Other: Short-foot exercise
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.
Other: Clam 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.
Other Names:
  • Short-foot exercise
Active Comparator: Control group
The control group will do only short-foot exercise.
Other: Short-foot exercise
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Medial longitudinal arch height-Navicular Drop Test
Time Frame: 6 weeks
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Static foot posture-Foot Posture Index-6
Time Frame: 6 weeks
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.
6 weeks
Foot structure-Photopodometric analysis
Time Frame: 6 weeks
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.
6 weeks
Recording demographic and clinical information on the evaluation form
Time Frame: 1 week
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mustafa Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-77082166-302.08.01-796166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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