- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07828392
Isolated Gastrocnemius Tightness and Tactile Sensitivity
Plantar Tactile Sensitivity Individuals With Isolated Gastrocnemius Tightness
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Niğde, Turkey (Türkiye)
- Nigde Omer Halisdemir University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18-65 with or without isolated gastrocnemius tightness,
- Individuals able to walk without experiencing pain
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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. |
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 |
|
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. |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
6 months
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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.
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6 months
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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.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabia ZORLULAR, Nigde Omer Halisdemir University
Publications and helpful links
General 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.
- DeBack 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Isolated Gastrocnemius
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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