Gastrocnemius TightnessNCT06363136
Foot Posture, Strength, Performance, and Postural Control in Isolated Gastrocnemius Tightness
An observational study of Gastrocnemius Tightness and Postural Control, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrocnemius Tightness, Postural Control, Muscle Strength
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 30 Jul 2024
- Phase
- Observational
- 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 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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)
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Postural Control Assessment
Postural stability, limits of stability, and sensory integration of balance will be assessed using the Biodex Balance System®.
Measured: 1 day
Lower extremity muscle strength measurement
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).
Measured: 1 day
Secondary outcomes (2)
Foot posture assessment
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.
Measured: 1 day
Functional performance assessment
The Single Leg and Double Leg Horizontal Jump Testswill be used to evaluate lower extremity functional performance.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Feb 2024
- Primary completion30 May 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrocnemius TightnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
- Investigators
- Deniz Tuncer, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363136
- Sponsor's protocol ID
- 14.06.2023-111176
- Status last verified
- Jul 2024
- First submitted
- 9 Apr 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eren-Zengin F, Tuncer D, Senaran H, Uzer G. Effects of isolated gastrocnemius tightness on foot posture, strength, function, and balance in children aged 7-16: a case-control study. BMC Sports Sci Med Rehabil. 2025 Oct 3;17(1):289. doi: 10.1186/s13102-025-01210-6.
PubMed 41039620
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Foot Posture, Muscle Strength, Functional Performance, and Postural Control in Children With Isolated Gastrocnemius Tightness
- ClinicalTrials.gov ID
- NCT06363136
- Acronym / sponsor ID
- 14.06.2023-111176
- Conditions
- Gastrocnemius Tightness, Postural Control, Muscle Strength, Functional Performance, Foot Posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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®.
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).
2 secondary outcomes
Foot posture assessment
Time frame: 1 day
Functional performance assessment
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 41039620Eren-Zengin F, Tuncer D, Senaran H, Uzer G. Effects of isolated gastrocnemius tightness on foot posture, strength, function, and balance in children aged 7-16: a case-control study. BMC Sports Sci Med Rehabil. 2025 Oct 3;17(1):289. doi: 10.1186/s13102-025-01210-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deniz Tuncer principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrocnemius Tightness and Postural Control, run by Bezmialem Vakif 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 12 inclusion and 0 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 30 Jul 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?
Postural Control Assessment (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT06363136, which also lists 1 linked publication.
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 30 Jul 2024.