Effects of Two Compression Socks on Balance and Ankle Stability in Healthy Adults (Not provided)

September 3, 2026 updated by: William J. Hanney, University of Central Florida

The Effect of a Novel Sock on Ankle Stability, Balance, and Muscle Contraction Time

This randomized study will compare a novel tensioning compression sock with a commercially available elastic foot and ankle compression sock in healthy adults. Participants will wear their assigned sock during waking hours for at least 6 hours per day for 7 days. Balance, ankle stability, grip strength, and tibialis anterior muscle contraction characteristics will be assessed at baseline and after the 7-day intervention. Participants will also report comfort and confidence in balance and stability after the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will attend two in-person visits separated by 7 days. After consent, screening, and baseline testing, participants will be randomized using a computer-generated sequence concealed in sequentially numbered opaque envelopes. Participants will receive either the Trak Ground Wear C001 High-Performance Compression Sock or a commercially available elastic foot and ankle compression sock and will wear it for at least 6 hours per day during waking hours. Assessments include the Y-Balance Test, Side Hop Test, Biodex Balance System, handgrip dynamometry, and tensiomyography of the tibialis anterior. A post-intervention questionnaire will assess perceived comfort, balance confidence, stability, and willingness to wear the assigned sock.

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.
Interventional

Enrollment (Estimated)

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.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18 years or older
  • Able to perform sit-to-stand, jumping, and single-leg standing without pain or discomfort
  • Able to read, write, and speak sufficient English to complete the study questionnaire
  • Shoe size within the study sock range: men's sizes 4-14 or women's sizes 6-13

Exclusion Criteria:

  • Feelings of ankle instability
  • An ankle injury within the previous 12 months
  • Previous surgery on either lower extremity
  • History of torn ligaments or cartilage at the hip, knee, or ankle
  • Radicular symptoms in either lower extremity
  • Allergy to sock materials (80 percent nylon, 14 percent polyester, or 6 percent elastane)
  • Unable to consent
  • Pregnant
  • Prisoner

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Novel Tensioning Compression Sock
Participants wear the Trak Ground Wear C001 High-Performance Compression Sock during waking hours for at least 6 hours per day for 7 days.
Other: Novel Tensioning Compression Sock
Participants assigned to the control group will receive a commercially available elastic foot and ankle compression sock. Participants will be instructed to wear their assigned sock during waking hours for a minimum of 6 hours per day over the 7-day intervention period.
Active Comparator: Elastic Compression Sock
Participants wear a commercially available elastic foot and ankle compression sock during waking hours for at least 6 hours per day for 7 days.
Other: Elastic Compression Sock
Participants assigned to the control group will receive a commercially available elastic foot and ankle compression sock. Participants will be instructed to wear their assigned sock during waking hours for a minimum of 6 hours per day over the 7-day intervention period.

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
Y-Balance Test
Time Frame: 7 days
Mean Change From Baseline in Y-Balance Test Reach Distance at day 7 . Three recorded trials are completed in the anterior, posteromedial, and posterolateral directions on each limb and averaged.
7 days

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
Side Hop Test
Time Frame: 7 days
Change From Baseline in Side Hop Test Score at day 7. Participants perform repeated single-leg side hops across lines 40 centimeters apart for 30 seconds; the highest of two trials is recorded.
7 days
Biodex Balance System
Time Frame: 7 days
Mean Change From Baseline in Biodex Athlete Single Leg Stability Score at day 7. Three 20-second trials are completed on each lower extremity.
7 days
Grip Strength
Time Frame: 7 days
Mean Change From Baseline in Handgrip Strength at Day 7. Two maximal contractions are performed with each hand; the highest value for each hand is recorded.
7 days
Tensiomyography
Time Frame: 7 days
Mean Change From Baseline in Tibialis Anterior Contraction Time at Day 7. Two tensiomyography measurements are obtained for each limb and averaged.
7 days
Confidence Survey
Time Frame: 7 days
Participant-Reported Comfort, Balance Confidence, Stability, and Willingness to Wear the Assigned Sock at Day 7.
7 days

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.
University of Central Florida

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: William J Hanney, PhD, UCF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

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.
October 26, 2026

Primary Completion (Estimated)

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.
October 26, 2027

Study Completion (Estimated)

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.
October 26, 2027

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).
September 3, 2026

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.
September 3, 2026

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.
September 10, 2026

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.
September 10, 2026

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.
September 3, 2026

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.
September 1, 2026

More Information

Terms related to this study

Keywords

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.
  • 9151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared outside the research team. Results will be reported only in aggregate.

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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