NCT06363136

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

April 9, 2024

Last Update Submit

July 29, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Postural Control Assessment

    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

    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 Outcomes (2)

  • Foot posture assessment

    1 day

  • Functional performance assessment

    1 day

Study Arms (2)

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.

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Officials

  • Deniz Tuncer

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 12, 2024

Study Start

February 1, 2024

Primary Completion

May 30, 2024

Study Completion

July 30, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations