The Effect of Different Exercises on Lower Extremity Performance in Flexible Flatfoot

July 1, 2024 updated by: Dilek Hande Esen, Mustafa Kemal University

Comparison of Effect of Ankle Exercise in PNF Pattern and Clam Exercise on Lower Extremity Muscle Strengh and Performance in Adults With Flexible Flat Feet: A Randomized Controlled Trial

In the study, the effects of two different strengthening exercises combined with short foot exercise on lower extremity functional performance and muscle strength will be examined and compared in adults aged 18-45 years with flexible flatfoot. This study was designed as an experimental, 3-arm, parallel group, double-blind randomized controlled study that included a 6-week intervention period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Participants will be randomly divided into 3 different groups (control group, foot-ankle exercise group, hip exercise group). The control group will be instructed to perform only short foot exercise; the foot-ankle exercise group will be instructed to perform 3-dimensional foot-ankle extension exercise in proprioceptive neuromuscular facilitation (PNF) pattern in addition to short foot exercise; the hip exercise group will be instructed to perform hip abductor and external rotator muscle strengthening exercise (clam exercise) in addition to short foot exercise. Foot-ankle and hip exercises will be performed against resistance with the help of an elastic band, 3 days a week under the supervision of a physiotherapist and progression will be made by changing to a higher level of difficulty band color every 2 weeks. Short foot exercise will be performed every day of the week (3 days under the supervision of a physiotherapist; the rest of the days as a home exercise program) and will be progressed by changing position (sitting, standing, on one leg respectively) every 2 weeks. All exercises will be performed for 6 weeks. Assessments will be performed at the beginning and end of the exercises by another researcher blinded to group allocation. Isometric muscle strength of the intrinsic foot, four-way ankle circumference and hip abductor-external rotator muscles, endurance of the plantar flexors, forward jump and dynamic balance performance will be evaluated respectively.

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 (Estimated)

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.
60

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 18-45 years
  • Navicular drop is 10 mm or more
  • Getting a value of +6 points or more from the Foot Posture Index-6

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
  • Describe lower extremity and/or lower back pain in the last 6 months
  • Disorders that may affect cognition and balance (otitis media, visual impairment, etc.)
  • Body mass index being above normal values (18-24.9 kg/m2)
  • Having rigid flat feet and/or hallux rigidus-limitus deformity
  • Being involved in regular sports or exercise
  • Having received any physiotherapy or rehabilitation treatment for flat feet or hips in the last year

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: PNF exercise group
All groups will be subjected to exercise training for 6 weeks: PNF exercise group will receive 3-dimensional (3D) foot-ankle extension exercise and short-foot exercise. The exercise will be performed 2 days a week under the supervision of a physiotherapist and 1 day as home exercise; KA exercise will be performed daily, 2 days under the supervision of a physiotherapist and the other days as home exercise.
Other: PNF exercise
Ankle and foot exercises practiced for 6 weeks.
Other: Short-foot exercise
Foot exercise practiced together for 6 weeks.
Experimental: Clam exercise group
All groups will be subjected to exercise training for 6 weeks: Clam exercise group will receive mussel exercise and short-foot exercise. The exercise will be performed 2 days a week under the supervision of a physiotherapist and 1 day as home exercise; KA exercise will be performed daily, 2 days under the supervision of a physiotherapist and the other days as home exercise.
Other: Short-foot exercise
Foot exercise practiced together for 6 weeks.
Other: Clam exercise
Hip exercise practiced for 6 weeks.
Active Comparator: Control group
All groups will be subjected to exercise training for 6 weeks: Control group will receive only KA exercise and this exercise will be performed daily, 2 days under the supervision of a physiotherapist and the other days as home exercise.
Other: Short-foot exercise
Foot exercise practiced together 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
Time Frame: 6 weeks
Medial longitudinal arch height will be evaluated with the navicular drop test.
6 weeks
Static foot posture
Time Frame: 6 weeks
Static foot posture will be evaluated with Foot Posture Index-6.
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
Isometric muscle strength
Time Frame: 6 weeks
Abductor hallucis, flexor digitorum brevis, flexor hallucis brevis, 4-way ankle muscles and hip abductor/external rotator isometric muscle strength will be evaluated using a digital hand-held dynamometer.
6 weeks
Lower extremity functional performance
Time Frame: 6 weeks
With plantar flexor focused endurance performance heel raise test; with dynamic balance Y balance test; Single leg forward jump performance will be evaluated with the single leg hop for distance test.
6 weeks

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dilek Esen, PhD. c, Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

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

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.
April 30, 2024

Primary Completion (Estimated)

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.
July 30, 2024

Study Completion (Estimated)

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.
September 30, 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).
June 26, 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.
June 26, 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.
July 1, 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.
July 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.
July 1, 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.
July 1, 2024

More Information

Terms related to this study

Keywords

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-77082166-604.01-930455

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

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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