Isolated Gastrocnemius TightnessNCT07828392
Isolated Gastrocnemius Tightness and Tactile Sensitivity
An observational study of Isolated Gastrocnemius Tightness and Healthy Adult Participants, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
Isolated gastrocnemius tightness is associated with various foot pathologies, particularly metatarsalgia and hallux valgus, and is also commonly observed in the general population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Isolated Gastrocnemius Tightness, Healthy Adult Participants
- What is being tested?
- Ankle Dorsiflexion Index
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2026to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: It is planned to include a total of 40 participants in this study: 20 individuals with isolated gastrocnemius tightness and 20 without.
Who may be able to join
- Adults aged 18-65 with or without isolated gastrocnemius tightness,
- Individuals able to walk without experiencing pain
Who cannot join
- Presence of neuromuscular disease,
- Conditions affecting plantar tactile sensation, such as diabetes,
- History of prior surgical procedures distal to the knee joint,
- Any current or previous symptoms related to the foot or ankle region,
- Presence of joint hypermobility,
- Individuals who do not volunteer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nigde Omer Halisdemir University
Niğde
Rabia ZORLULAR, +5424362082, rabiaeraslan118@gmail.com
About this study
Official title: Plantar Tactile Sensitivity Individuals With Isolated Gastrocnemius Tightness
Isolated gastrocnemius tightness is associated with various foot pathologies, particularly metatarsalgia and hallux valgus, and is also commonly observed in the general population. Limited ankle dorsiflexion, typically resulting from tightness of the gastrocnemius-soleus complex, may alter normal gait mechanics and lead to compensatory movement patterns that increase mechanical stress on the lower extremity. It is planned to include a total of 40 participants in this study: 20 individuals with isolated gastrocnemius tightness and 20 without. The participants' plantar tactile sensitivity and postural control characteristics will be compared.
Read the detailed description
Isolated gastrocnemius tightness has been widely studied in the adult population and is associated with various foot and ankle pathologies, such as plantar fasciitis, plantar ulcers, achilles tendinopathy, pes planus, and posterior tibial tendon dysfunction. However, no study evaluating plantar tactile sensation in individuals with isolated gastrocnemius tightness has been found in the existing literature. The findings of this study are expected to contribute to the existing literature regarding the relationship between isolated gastrocnemius tightness and plantar tactile sensation and postural control. Evaluating plantar tactile sensitivity and postural control together may help elucidate not only the mechanical effects of isolated gastrocnemius tightness on joint range of motion but also its potential effects related to sensory and postural control. This study plans to include 40 participants: 20 with isolated gastrocnemius tightness and 20 without. The participants' plantar tactile sensitivity and postural control characteristics will be compared.
- Being tested
- Ankle Dorsiflexion Index
- Keywords
- Isolated gastrocnemius tightness, tactile sensitivity, postural control, foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Dorsiflexion IndexBehavioural
First, the participant will be asked to move their knee forward-while keeping the heel of the tested foot in full contact with the ground and the foot aligned forward-until reaching the maximum dorsiflexion position possible without the heel lifting off the ground.
Ankle dorsiflexion range of motion will be measured with the knee flexed at a minimum of 20°. Subsequently, the same assessment will be repeated with the knee in full extension (0°). Under both conditions, the maximum angular change occurring during the forward movement of the tibia relative to the starting position will be recorded as the ankle dorsiflexion range of motion.
The difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the Ankle Dorsiflexion Index
| Study group | Role | What they receive |
|---|---|---|
| individuals with isolated gastrocnemius tightness | The difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the ankle dorsiflexion index (ADI):
•Ankle dorsiflexion index = Dorsiflexion with knee at 20° flexion - dorsiflexion with knee in full extension The threshold value of ADI ≥10°, commonly used in the literature for classifying isolated gastrocnemius tightness, will be taken into account. Receives: Behavioral: Ankle Dorsiflexion Index | |
| individuals without isolated gastrocnemius tightness | The difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the Ankle Dorsiflexion Index:
For individuals without isolated gastrocnemius tightness, a threshold value of <10° for the Ankle Dorsiflexion Index will be considered. Receives: Behavioral: Ankle Dorsiflexion Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle dorsiflexion index
First, the participant will be asked to move their knee forward-while keeping the heel of the tested foot in full contact with the ground and the foot aligned forward-until reaching the maximum dorsiflexion position possible without the heel lifting off the ground.
Ankle dorsiflexion range of motion will be measured with the knee flexed at a minimum of 20°. Subsequently, the same assessment will be repeated with the knee in full extension (0°). Under both conditions, the maximum angular change occurring during the forward movement of the tibia relative to the starting position will be recorded as the ankle dorsiflexion range of motion.
The difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the ankle dorsiflexion index.
Measured: 6 months
Assessment of postural control
Postural control will be assessed using a force plate (KINVENT, France). Data will be transmitted to the force plate application via a Bluetooth connection. Prior to the actual measurements, participants will be informed about the force platform and the test conditions, and a practice trial will be conducted to familiarize them with the tests. Static postural control will be assessed under three different conditions: (1) standing on both feet with eyes open, (2) standing on both feet with eyes closed, and (3) standing on one foot with eyes open. In the assessment of postural control, the primary Center of Pressure parameters-mean Center of Pressure velocity, Center of Pressure path length, and sway area-were evaluated.
Measured: 6 months
Plantar tactile sensitivity
Plantar tactile sensitivity will be assessed using Semmes-Weinstein monofilaments. During the assessment, participants will be positioned prone, with their feet hanging freely off the edge of the examination table and not touching any surface. The assessment will begin with the monofilament that applies the lowest force, and the procedure will progress to progressively thicker monofilaments until the participant perceives the stimulus. The lowest Semmes-Weinstein monofilament value perceived in these areas will be recorded as the plantar tactile sensation threshold. Lower perceived pressure values indicate higher tactile sensitivity in the sole of the participant's foot.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start8 Sep 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Isolated 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia ZORLULAR, Nigde Omer Halisdemir University
- Investigators
- Rabia ZORLULAR, Principal investigator, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828392
- Sponsor's protocol ID
- Isolated Gastrocnemius
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MARINACCIO L. [Frequency and clinical and histological significance of diseases of the uterus; critical and statistical observations on biopsies]. G Clin Med. 1953 Jul;34(7):788-823. No abstract available. Undetermined Language.
PubMed 13095768DeBack V. We have a part to play in changing the world: a conversation with Dr Vivien DeBack. Int Nurs Rev. 2002 Dec;49(4):199-201. doi: 10.1046/j.1466-7657.2002.00150.x. No abstract available.
PubMed 12492940
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar Tactile Sensitivity Individuals With Isolated Gastrocnemius Tightness
- ClinicalTrials.gov ID
- NCT07828392
- Acronym / sponsor ID
- Isolated Gastrocnemius
- Keywords
- Isolated gastrocnemius tightness, tactile sensitivity, postural control, foot
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Sep 2026 (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.
Isolated gastrocnemius tightness is associated with various foot pathologies, particularly metatarsalgia and hallux valgus, and is also commonly observed in the general population. Limited ankle dorsiflexion, typically resulting from tightness of the gastrocnemius-soleus complex, may alter normal gait mechanics and lead to compensatory movement patterns that increase mechanical stress on the lower extremity. It is planned to include a total of 40 participants in this study: 20 individuals with isolated gastrocnemius tightness and 20 without. The participants' plantar tactile sensitivity and postural control characteristics will be compared.
Detailed description
Isolated gastrocnemius tightness has been widely studied in the adult population and is associated with various foot and ankle pathologies, such as plantar fasciitis, plantar ulcers, achilles tendinopathy, pes planus, and posterior tibial tendon dysfunction. However, no study evaluating plantar tactile sensation in individuals with isolated gastrocnemius tightness has been found in the existing literature. The findings of this study are expected to contribute to the existing literature regarding the relationship between isolated gastrocnemius tightness and plantar tactile sensation and postural control. Evaluating plantar tactile sensitivity and postural control together may help elucidate not only the mechanical effects of isolated gastrocnemius tightness on joint range of motion but also its potential effects related to sensory and postural control. This study plans to include 40 participants: 20 with isolated gastrocnemius tightness and 20 without. The participants' plantar tactile sensitivity and postural control characteristics will be compared.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individuals with isolated gastrocnemius tightness | – | Behavioral: Ankle Dorsiflexion IndexThe difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the ankle dorsiflexion index (ADI): •Ankle dorsiflexion index = Dorsiflexion with knee at 20° flexion - dorsiflexion with knee in full extension The threshold value of ADI ≥10°, commonly used in the literature for classifying isolated gastrocnemius tightness, will be taken into account. |
| individuals without isolated gastrocnemius tightness | – | Behavioral: Ankle Dorsiflexion IndexThe difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the Ankle Dorsiflexion Index: For individuals without isolated gastrocnemius tightness, a threshold value of <10° for the Ankle Dorsiflexion Index will be considered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to include a total of 40 participants in this study: 20 individuals with isolated gastrocnemius tightness and 20 without.
Key inclusion criteria (2 listed)
- Adults aged 18-65 with or without isolated gastrocnemius tightness,
- Individuals able to walk without experiencing pain
Key exclusion criteria (6 listed)
- Presence of neuromuscular disease,
- Conditions affecting plantar tactile sensation, such as diabetes,
- History of prior surgical procedures distal to the knee joint,
- Any current or previous symptoms related to the foot or ankle region,
- Presence of joint hypermobility,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle Dorsiflexion IndexFirst, the participant will be asked to move their knee forward-while keeping the heel of the tested foot in full contact with the ground and the foot aligned forward-until reaching the maximum dorsiflexion position possible without the heel lifting off the ground. Ankle dorsiflexion range of motion will be measured with the knee flexed at a minimum of 20°. Subsequently, the same assessment will be repeated with the knee in full extension (0°). Under both conditions, the maximum angular change occurring during the forward movement of the tibia relative to the starting position will be recorded as the ankle dorsiflexion range of motion. The difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the Ankle Dorsiflexion Index | Behavioural | individuals with isolated gastrocnemius tightness, individuals without isolated gastrocnemius tightness |
Primary outcome
Ankle dorsiflexion index
Time frame: 6 months
First, the participant will be asked to move their knee forward-while keeping the heel of the tested foot in full contact with the ground and the foot aligned forward-until reaching the maximum dorsiflexion position possible without the heel lifting off the ground. Ankle dorsiflexion range of motion will be measured with the knee flexed at a minimum of 20°. Subsequently, the same assessment will be repeated with the knee in full extension (0°). Under both conditions, the maximum angular change occurring during the forward movement of the tibia relative to the starting position will be recorded as the ankle dorsiflexion range of motion. The difference between the mean dorsiflexion values obtained with the knee flexed at a minimum of 20° and in full extension will be calculated as the ankle dorsiflexion index.
Assessment of postural control
Time frame: 6 months
Postural control will be assessed using a force plate (KINVENT, France). Data will be transmitted to the force plate application via a Bluetooth connection. Prior to the actual measurements, participants will be informed about the force platform and the test conditions, and a practice trial will be conducted to familiarize them with the tests. Static postural control will be assessed under three different conditions: (1) standing on both feet with eyes open, (2) standing on both feet with eyes closed, and (3) standing on one foot with eyes open. In the assessment of postural control, the primary Center of Pressure parameters-mean Center of Pressure velocity, Center of Pressure path length, and sway area-were evaluated.
Plantar tactile sensitivity
Time frame: 6 months
Plantar tactile sensitivity will be assessed using Semmes-Weinstein monofilaments. During the assessment, participants will be positioned prone, with their feet hanging freely off the edge of the examination table and not touching any surface. The assessment will begin with the monofilament that applies the lowest force, and the procedure will progress to progressively thicker monofilaments until the participant perceives the stimulus. The lowest Semmes-Weinstein monofilament value perceived in these areas will be recorded as the plantar tactile sensation threshold. Lower perceived pressure values indicate higher tactile sensitivity in the sole of the participant's foot.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Results publication: PubMed 13095768MARINACCIO L. [Frequency and clinical and histological significance of diseases of the uterus; critical and statistical observations on biopsies]. G Clin Med. 1953 Jul;34(7):788-823. No abstract available. Undetermined Language.
- Results publication: PubMed 12492940DeBack V. We have a part to play in changing the world: a conversation with Dr Vivien DeBack. Int Nurs Rev. 2002 Dec;49(4):199-201. doi: 10.1046/j.1466-7657.2002.00150.x. No abstract available.
- Individual participant dataSharing planned: No
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.
Rabia ZORLULAR principal investigator
Nigde Omer Halisdemir 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 Isolated Gastrocnemius Tightness and Healthy Adult Participants, run by Nigde Omer Halisdemir 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rabia ZORLULAR (+5424362082, rabiaeraslan118@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle dorsiflexion index (time frame: 6 months). The study lists 3 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 NCT07828392, which also lists 2 linked publications.
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 9 Oct 2026.