Ankle StabilityNCT06871085
Novel Sock Design on Ankle and Postural Stability
A study testing Stability Sock in people with Ankle Stability and Postural Stability, run by University of Central Florida at 1 site in United States.
Trial summary
This study uses a prospective cohort study design using a convenience sample to explore the sock's impact on various aspects of ankle function and overall stability. A secondary objective is measuring subjective changes in reported confidence levels in performing balance and stability exercises with and without sock Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Stability, Postural Stability
- What is being tested?
- Stability Sock
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 25 Aug 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum of 18 years old or older
- Able to perform the following actions with no pain or discomfort: sit-to-stand, jump, one leg stand
- Must read, write, and speak sufficient English in order to complete subjective questionnaire
Who cannot join
- Had a previous foot or leg injury
- Had a foot condition at the time of their participation in the study
- Had feelings of instability at the ankle
- Had an ankle injury within the past 12 months
- Had surgery on either lower extremity in the past
- Had any torn ligaments or cartilage at the hip, knee, or ankle
Show all 12Show fewer
- Experienced radicular symptoms down either lower extremity
- Had any allergies to the sock material used in the study
- 80% nylon
- 14% polyester
- 6% elastane
- Is currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: Effectiveness of a Novel Sock Design on Ankle and Postural Stability
This study uses a prospective cohort study design using a convenience sample to explore the sock's impact on various aspects of ankle function and overall stability. A secondary objective is measuring subjective changes in reported confidence levels in performing balance and stability exercises with and without sock
Read the detailed description
Study Design: This study uses a prospective cohort design to assess the effects of wearing the novel sock on ankle stability, muscle activation, and functional performance.
Participant Consent:
All participants will provide informed consent before beginning the study. They will be given the opportunity to ask questions about the procedures and consent will be documented by both the participant and the researcher. This process will take about 5 minutes.
Participant Screening:
Each participant will undergo screening based on the inclusion/exclusion criteria. They must be 18 years or older, with no recent ankle injury or surgery and no reported feelings of ankle instability or allergies to the sock material.
A medical history questionnaire will be completed by each participant to confirm their eligibility. This process will take about 5 minutes.
Warm-up and Familiarization:
Participants will undergo the previously described warm-up, including 10 repetitions of specific exercises (toe spreads, toe raises, heel raises) and walking 120 meters to familiarize themselves with the sock. Warm-up will take 30 seconds for each exercise, and walking for familiarization will take about 1 minute.
Functional Assessments:
All assessments will be performed with and without the sock. The performance of the assessments with or without the socks will be randomized with each participant. Once randomized, all assessments will be performed and then the patient will either put on or take off the sock and perform the assessments again.
Grip Strength:
Grip strength will be measured using a hand dynamometer. Participants will sit in a chair with no armrests, feet flat on the floor, and squeeze the dynamometer with each hand while their forearm is positioned in a neutral position.
Two trials will be conducted per hand, alternating hands with a 1-minute rest between each trial. The average of the two trials will be recorded. This assessment will take about 5 minutes.
Single Leg Stance:
This test measures static balance. Participants will be asked to stand on one leg, starting with the right leg. Timing will start when the participant lifts one foot off the ground and will stop when balance is lost or the foot touches the ground again.
Each leg will be tested, and the average time from two trials will be recorded. This assessment will take about 5 minutes.
Y-Balance Test (YBT):
The YBT will be used to measure dynamic balance. Participants will stand on one leg and use the other leg to push a reach indicator in three different directions (anterior, posteromedial, and posterolateral).
Six practice trials will be done, followed by three measured trials per leg. The distances reached will be recorded, and the average of the last three trials of each leg will be taken This assessment will take about 8 minutes.
Functional Reach Standing:
Participants will stand with their arm extended at 90 degrees and reach as far forward as possible without stepping. The distance reached will be measured and recorded using a yardstick.
This test measures postural control and stability. This assessment will take about 2 minutes.
Single Leg Hop:
This test will measure dynamic balance and power. Participants will perform three types of hops: forward, lateral, and triple hops, landing on one leg. Each landing will be observed and assessed for balance. Participants will perform one practice attempt, then three trials for each test. The average of the three attempts will be recorded.
The distance for each hop and any balance errors will be recorded. This assessment will take about 8 minutes.
Balance Error Scoring System (BESS):
Participants will perform balance stances (double leg, single leg, and tandem) on both a flat surface and foam pad for 20 seconds each. The researcher will record any balance errors such as eye opening or stepping off the testing surface. This assessment will take about 3 minutes.
Fingertip to Floor Test (FFT) Participants will stand with their feet together on a 21.2 cm box and try to bend forward to reach as far down towards the floor as possible without bending their knees. Distance of fingertips from the ground will be recorded, if their fingertips touch the floor their radial styloid process will be used instead to measure the distance from the floor, using a ruler in centimeters. 1 practice trial will be conducted followed by 1 test trial. This test will take about 2 minutes to complete.
After all tests have been performed with and without the novel sock, the participants will be asked to complete a google form questionnaire about their perceptions of their performance with and without the sock.
- Conditions
- Ankle Stability, Postural Stability
- Being tested
- Stability Sock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stability SockDevice
Use of a stability sock
| Study group | Role | What they receive |
|---|---|---|
| Sock | Experimental | Ankle and postural stability will be evaluated with and without use of a novel stability sock Receives: Device: Stability Sock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength:
Grip strength will be measured using a hand dynamometer. Participants will sit in a chair with no armrests, feet flat on the floor, and squeeze the dynamometer with each hand while their forearm is positioned in a neutral position.
Two trials will be conducted per hand, alternating hands with a 1-minute rest between each trial. The average of the two trials will be recorded. This assessment will take about 5 minutes.
Measured: Immediately after intervention
Single Leg Stance
This test measures static balance. Participants will be asked to stand on one leg, starting with the right leg. Timing will start when the participant lifts one foot off the ground and will stop when balance is lost or the foot touches the ground again.
Each leg will be tested, and the average time from two trials will be recorded. This assessment will take about 5 minutes.
Measured: Immediately after intervention
Y-Balance Test (YBT)
The YBT will be used to measure dynamic balance. Participants will stand on one leg and use the other leg to push a reach indicator in three different directions (anterior, posteromedial, and posterolateral).
Six practice trials will be done, followed by three measured trials per leg. The distances reached will be recorded, and the average of the last three trials of each leg will be taken This assessment will take about 8 minutes.
Measured: Immediately after intervention
Functional Reach Standing
Participants will stand with their arm extended at 90 degrees and reach as far forward as possible without stepping. The distance reached will be measured and recorded using a yardstick.
This test measures postural control and stability. This assessment will take about 2 minutes.
Measured: Immediately after intervention
Single Leg Hop
This test will measure dynamic balance and power. Participants will perform three types of hops: forward, lateral, and triple hops, landing on one leg. Each landing will be observed and assessed for balance. Participants will perform one practice attempt, then three trials for each test. The average of the three attempts will be recorded.
The distance for each hop and any balance errors will be recorded. This assessment will take about 8 minutes.
Measured: Immediately after intervention
Balance Error Scoring System (BESS)
Participants will perform balance stances (double leg, single leg, and tandem) on both a flat surface and foam pad for 20 seconds each. The researcher will record any balance errors such as eye opening or stepping off the testing surface. This assessment will take about 3 minutes.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start3 Mar 2025
- Primary completion25 Aug 2026
- Study completion25 Aug 2026
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 Ankle StabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William J. Hanney, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871085
- Sponsor's protocol ID
- STUDY00007246
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available upon request
Publications
Taylor JB, Wright ES, Waxman JP, Schmitz RJ, Groves JD, Shultz SJ. Ankle Dorsiflexion Affects Hip and Knee Biomechanics During Landing. Sports Health. 2022 May-Jun;14(3):328-335. doi: 10.1177/19417381211019683. Epub 2021 Jun 6.
PubMed 34096370
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel Sock Design on Ankle and Postural Stability
- ClinicalTrials.gov ID
- NCT06871085
- Acronym / sponsor ID
- STUDY00007246
- Conditions
- Ankle Stability, Postural Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 11 Mar 2025 (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.
This study uses a prospective cohort study design using a convenience sample to explore the sock's impact on various aspects of ankle function and overall stability. A secondary objective is measuring subjective changes in reported confidence levels in performing balance and stability exercises with and without sock
Detailed description
Study Design: This study uses a prospective cohort design to assess the effects of wearing the novel sock on ankle stability, muscle activation, and functional performance.
Participant Consent:
All participants will provide informed consent before beginning the study. They will be given the opportunity to ask questions about the procedures and consent will be documented by both the participant and the researcher. This process will take about 5 minutes.
Participant Screening:
Each participant will undergo screening based on the inclusion/exclusion criteria. They must be 18 years or older, with no recent ankle injury or surgery and no reported feelings of ankle instability or allergies to the sock material.
A medical history questionnaire will be completed by each participant to confirm their eligibility. This process will take about 5 minutes.
Warm-up and Familiarization:
Participants will undergo the previously described warm-up, including 10 repetitions of specific exercises (toe spreads, toe raises, heel raises) and walking 120 meters to familiarize themselves with the sock. Warm-up will take 30 seconds for each exercise, and walking for familiarization will take about 1 minute.
Functional Assessments:
All assessments will be performed with and without the sock. The performance of the assessments with or without the socks will be randomized with each participant. Once randomized, all assessments will be performed and then the patient will either put on or take off the sock and perform the assessments again.
Grip Strength:
Grip strength will be measured using a hand dynamometer. Participants will sit in a chair with no armrests, feet flat on the floor, and squeeze the dynamometer with each hand while their forearm is positioned in a neutral position.
Two trials will be conducted per hand, alternating hands with a 1-minute rest between each trial. The average of the two trials will be recorded. This assessment will take about 5 minutes.
Single Leg Stance:
This test measures static balance. Participants will be asked to stand on one leg, starting with the right leg. Timing will start when the participant lifts one foot off the ground and will stop when balance is lost or the foot touches the ground again.
Each leg will be tested, and the average time from two trials will be recorded. This assessment will take about 5 minutes.
Y-Balance Test (YBT):
The YBT will be used to measure dynamic balance. Participants will stand on one leg and use the other leg to push a reach indicator in three different directions (anterior, posteromedial, and posterolateral).
Six practice trials will be done, followed by three measured trials per leg. The distances reached will be recorded, and the average of the last three trials of each leg will be taken This assessment will take about 8 minutes.
Functional Reach Standing:
Participants will stand with their arm extended at 90 degrees and reach as far forward as possible without stepping. The distance reached will be measured and recorded using a yardstick.
This test measures postural control and stability. This assessment will take about 2 minutes.
Single Leg Hop:
This test will measure dynamic balance and power. Participants will perform three types of hops: forward, lateral, and triple hops, landing on one leg. Each landing will be observed and assessed for balance. Participants will perform one practice attempt, then three trials for each test. The average of the three attempts will be recorded.
The distance for each hop and any balance errors will be recorded. This assessment will take about 8 minutes.
Balance Error Scoring System (BESS):
Participants will perform balance stances (double leg, single leg, and tandem) on both a flat surface and foam pad for 20 seconds each. The researcher will record any balance errors such as eye opening or stepping off the testing surface. This assessment will take about 3 minutes.
Fingertip to Floor Test (FFT) Participants will stand with their feet together on a 21.2 cm box and try to bend forward to reach as far down towards the floor as possible without bending their knees. Distance of fingertips from the ground will be recorded, if their fingertips touch the floor their radial styloid process will be used instead to measure the distance from the floor, using a ruler in centimeters. 1 practice trial will be conducted followed by 1 test trial. This test will take about 2 minutes to complete.
After all tests have been performed with and without the novel sock, the participants will be asked to complete a google form questionnaire about their perceptions of their performance with and without the sock.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sock | Experimental | Device: Stability SockAnkle and postural stability will be evaluated with and without use of a novel stability sock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Minimum of 18 years old or older
- Able to perform the following actions with no pain or discomfort: sit-to-stand, jump, one leg stand
- Must read, write, and speak sufficient English in order to complete subjective questionnaire
Key exclusion criteria (12 listed)
- Had a previous foot or leg injury
- Had a foot condition at the time of their participation in the study
- Had feelings of instability at the ankle
- Had an ankle injury within the past 12 months
- Had surgery on either lower extremity in the past
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 |
|---|---|---|
| Stability SockUse of a stability sock | Device | Sock |
Primary outcome
Grip Strength:
Time frame: Immediately after intervention
Grip strength will be measured using a hand dynamometer. Participants will sit in a chair with no armrests, feet flat on the floor, and squeeze the dynamometer with each hand while their forearm is positioned in a neutral position. Two trials will be conducted per hand, alternating hands with a 1-minute rest between each trial. The average of the two trials will be recorded. This assessment will take about 5 minutes.
Single Leg Stance
Time frame: Immediately after intervention
This test measures static balance. Participants will be asked to stand on one leg, starting with the right leg. Timing will start when the participant lifts one foot off the ground and will stop when balance is lost or the foot touches the ground again. Each leg will be tested, and the average time from two trials will be recorded. This assessment will take about 5 minutes.
Y-Balance Test (YBT)
Time frame: Immediately after intervention
The YBT will be used to measure dynamic balance. Participants will stand on one leg and use the other leg to push a reach indicator in three different directions (anterior, posteromedial, and posterolateral). Six practice trials will be done, followed by three measured trials per leg. The distances reached will be recorded, and the average of the last three trials of each leg will be taken This assessment will take about 8 minutes.
Functional Reach Standing
Time frame: Immediately after intervention
Participants will stand with their arm extended at 90 degrees and reach as far forward as possible without stepping. The distance reached will be measured and recorded using a yardstick. This test measures postural control and stability. This assessment will take about 2 minutes.
Single Leg Hop
Time frame: Immediately after intervention
This test will measure dynamic balance and power. Participants will perform three types of hops: forward, lateral, and triple hops, landing on one leg. Each landing will be observed and assessed for balance. Participants will perform one practice attempt, then three trials for each test. The average of the three attempts will be recorded. The distance for each hop and any balance errors will be recorded. This assessment will take about 8 minutes.
Balance Error Scoring System (BESS)
Time frame: Immediately after intervention
Participants will perform balance stances (double leg, single leg, and tandem) on both a flat surface and foam pad for 20 seconds each. The researcher will record any balance errors such as eye opening or stepping off the testing surface. This assessment will take about 3 minutes.
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 28 Aug 2026.
- Background: PubMed 34096370Taylor JB, Wright ES, Waxman JP, Schmitz RJ, Groves JD, Shultz SJ. Ankle Dorsiflexion Affects Hip and Knee Biomechanics During Landing. Sports Health. 2022 May-Jun;14(3):328-335. doi: 10.1177/19417381211019683. Epub 2021 Jun 6.
- Individual participant dataSharing planned: Yes. IPD will be available upon request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stability Sock in people with Ankle Stability and Postural Stability, run by University of Central Florida at 1 site in United States.
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 3 inclusion and 12 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 28 Aug 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 United States. 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?
Grip Strength: (time frame: Immediately after intervention). The study lists 6 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 NCT06871085, 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 28 Aug 2026.