Foot Posture, Strength, Performance, and Postural Control in Isolated Gastrocnemius Tightness

July 29, 2024 updated by: Deniz Tuncer, Bezmialem Vakif University

Evaluation of Foot Posture, Muscle Strength, Functional Performance, and Postural Control in Children With Isolated Gastrocnemius Tightness

Studies on gastrocnemius tightness in healthy children are limited, but there is evidence that ankle dorsiflexion decreases with increasing age in children. It is not known whether gastrocnemius tightness is a normal finding in children, but recurrent leg pain is common in children. It is also known that flexible flatfoot is a normal observation in developing children and that the medial longitudinal arch develops during the first decade of life. Both foot morphology and ankle dorsiflexion change in developing children; however, it is not known whether there is a relationship between them or not.

In the literature, there is no study evaluating foot posture, muscle strength, functional performance, and postural control in children with isolated gastrocnemius muscle tightness. It was planned to evaluate postural control using computerized dynamic posturography (Biodex Balance System), lower extremity muscle strength using a hand-held dynamometer, foot posture using the Foot Posture Index (FPI-6), and functional performance using single-foot-double-foot jump tests in healthy children with isolated gastrocnemius muscle tightness.

Study Overview

Status

Status

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

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.

Detailed Description

Since the gastrocnemius muscle spans both joints, the kinematics of the ankle joint are influenced by knee flexion. According to Kendall & McCreary's assessment of normal joint motion angles, when the knee joint is in extension, the passive dorsiflexion angle of the ankle is approximately 20°, and with knee flexion, the angle can approach 30° due to the relaxation of the gastrocnemius. During the midstance phase of walking, the ankle joint allows for 8-10° of dorsiflexion movement. The evaluation of gastrocnemius muscle tightness is conducted using the Silfverskiold method. However, there are variations in the definitions proposed for the detection of isolated gastrocnemius tightness. In our investigation, when ankle dorsiflexion rises by at least 10° more in knee flexion than knee extension, isolated gastrocnemius tightness will be taken into account.

Isolated gastrocnemius tightness during walking can result in compensatory effects on the lower extremity and foot, causing biomechanical changes such as pes planus, talus eversion, rearfoot pronation, and various symptoms such as plantar fasciitis, leg pain, metatarsalgia, and Achilles tendinopathy. The association between increased rearfoot pronation and isolated gastrocnemius tightness has been demonstrated in the literature. Regardless of the etiology of rearfoot pronation, adaptive isolated gastrocnemius shortening will occur in conjunction with talar plantar flexion. Isolated gastrocnemius tightness causing plantar flexion at the ankle joint and pronation at the subtalar joint also hinders the normal distribution of load on the plantar surface during weight-bearing. Reviewing the literature, it is observed that the effects of isolated gastrocnemius tightness on foot posture, functional parameters, and gait dynamics, especially rearfoot pronation, are reported.

Studies on gastrocnemius tightness in healthy children are limited, but there is evidence that ankle dorsiflexion decreases with age in children. While it is unknown whether gastrocnemius shortening is a normal finding in children, recurrent leg pain is common in children. Additionally, flexible flatfoot is considered a normal observation in developing children, and it is known that the medial longitudinal arch develops in the first ten years of life. Both foot morphology and ankle dorsiflexion change in developing children, but it is unknown whether there is a relationship between the two.

In the literature, there is no study evaluating foot posture, muscle strength, functional performance, and postural control in children with isolated gastrocnemius muscle shortening. In our study, we plan to assess postural control using computerized dynamic posturography (Biodex Balance System), lower extremity muscle strength using a hand-held dynamometer, foot posture using the Foot Posture Index (FPI-6), and functional performance using single-leg and double-leg hop tests in healthy children with isolated gastrocnemius muscle shortening.

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.
Observational

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.
28

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bezmialem Vakif University

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

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will recruit 14 children aged 7-16 years who were followed up by Bezmialem Vakıf University Department of Orthopaedics and Traumatology for bilateral isolated gastrocnemius tightness who participated voluntarily. In addition, 14 healthy children of the same age group consisting of relatives of the participating families and healthy relatives of the students studying in the department will be included. The cross-sectional study will be conducted in accordance with the Declaration of Helsinki.

After obtaining informed consent from both parents and children, all evaluations and tests for the participants will be performed at Bezmialem Vakıf University Faculty of Health Sciences Paediatric and Cardiac Physiotherapy and Rehabilitation Education and Research Laboratories.

Description

Inclusion Criteria:

Study group

  • Presence of bilateral isolated gastrocnemius tightness (The test is considered positive when ankle dorsal flexion dorsiflexion increases over a minimum of 10 degrees with the knee flexed than the knee extension.
  • Being between 7-16 years of age
  • Body mass index within normal limits (18.5-24.9 kg/m2) Exclusion criteria
  • Presence of high femoral anteversion, internal tibial torsion, and metatarsus adductus
  • Presence of hypermobility (Beighton score >4 and above)
  • Leg length discrepancy
  • Presence of any neurological, rheumatic, musculoskeletal, metabolic, and connective tissue disease
  • History of pain, deformity, or surgery associated with the vertebral column and lower extremities
  • Presence of cognitive, mental, and/or severe psychiatric illness
  • Participation in any exercise program or sportive activity in the last six months

For the control group, the same inclusion/exclusion criteria will be accepted except that the bilateral Silfverskiold test is negative.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Study group
The group will include 14 children aged 7-16 who are voluntarily participating and being followed for bilateral isolated gastrocnemius tightness by the Department of Orthopedics and Traumatology at Bezmialem Vakif University.
Control group
The group will consist 14 healthy children from the same age group.

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
Postural Control Assessment
Time Frame: 1 day
Postural stability, limits of stability, and sensory integration of balance will be assessed using the Biodex Balance System®.
1 day
Lower extremity muscle strength measurement
Time Frame: 1 day
The strength of hip adductors-abductors, external-internal rotators, flexors-extensors, knee flexors-extensors, and ankle dorsiflexors-plantar flexors, invertors-evertors muscles will be evaluated isometrically using a handheld dynamometer (MicroFET 2 force gauge, Hoggan Health Industries, Salt Lake City, Utah).
1 day

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
Foot posture assessment
Time Frame: 1 day
The Foot Posture Index (FPI-6) will be used to assess foot alignment in different planes. Six analyses will be scored on a +2 to -2 scale, and the total score will be recorded.
1 day
Functional performance assessment
Time Frame: 1 day
The Single Leg and Double Leg Horizontal Jump Testswill be used to evaluate lower extremity functional performance.
1 day

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.
Bezmialem Vakif 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: Deniz Tuncer, Bezmialem Vakif University

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 1, 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.
May 30, 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.
July 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).
April 9, 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.
April 9, 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.
April 12, 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 30, 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 29, 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

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.
  • 14.06.2023-111176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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