Ankle SprainNCT01210612

The Effect of Five-Toed Socks on Postural Control Among Active Individuals Who Have Chronic Ankle Instabilities

A study testing Unilateral CAI in people with Ankle Sprain, run by University of Toledo Health Science Campus at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Ankle Sprain
What is being tested?: Unilateral CAI
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: Sep 2010to Dec 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

member of university community
All subjects will be physically active (at least 30 minutes of sustained exercise 3 times/week

Who cannot join

history of: knee or hip musculoskeletal injury or surgery
history of: fracture or dislocation of the testing ankle or leg
neurological problems
vestibular disorders or concussions within the last 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Toledo
Toledo, Ohio, 43614

Other trials in United States

About this study

Lateral ankle sprain (LAS) is one of the most common injuries in sports. There is a unique style of socks that have become popular in Japan among athletes that could also improve postural control. The purpose of the study is to determine the effectiveness of five-toed socks on dynamic postural control in individuals with and without chronic ankle instability.

Read the detailed description

Lateral ankle sprain (LAS) is one of the most common injuries in sports. Ankle braces and orthotic insoles also have been shown to influence the neuromuscular control system by enhancing the proprioceptive and cutaneous afferent inputs to the central nerve system; thereby improving postural control. There is a unique style of socks that have become popular in Japan among athletes that could also improve postural control by enhancing cutaneous afferent inputs from the plantar surface of the foot and toes. The purpose of the study is to determine the effectiveness of five-toed socks on dynamic postural control in individuals with and without chronic ankle instability.

Conditions: Ankle Sprain
Being tested: Unilateral CAI
Medical subject headings: Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Unilateral CAIDevice
five-toed socks usage

Study groups in NCT01210612
Study group	Role	What they receive
Without Unilateral CAI	Active comparator	Individuals with no history of chronic ankle instability (CAI) Receives: Device: Unilateral CAI
With Unilateral CAI	Experimental	Individuals with a history of chronic ankle instability (CAI) that is affecting only one limb Receives: Device: Unilateral CAI

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Outcome Measurement for This Study Was to Determine Differences in Center of Pressure (COP) and Static Postural Control Patterns in Individuals With and Without CAI During the Single Limb Balance Test.
Participants were recruited to complete three testing sessions, separated by approximately one week. The participants were tested while wearing five-toed socks. Static postural control was assessed on a force plate (model 4060NC; Bertec Corp. Inc., Columbus, OH) with the subject in a single-limb stance. Center of Pressure (COP) data were sampled at 50Hz. The subjects completed three 15-second trials with a one-minute rest between trials. Motion Monitor software (Innovative Sports Training, Inc., Chicago, IL) collected COP data during the single-limb stance test. The primary outcome was COP-Velocity (cm/sec).
Measured: 3 weeks

Secondary outcomes (1)

Reaching Distances
The secondary outcome measurement for this study will be to determine differences in the mean value of the three reaching distances (the anterior, posterior lateral, and posterior medial direction) of the SEBT in individuals with and without chronic ankle instability. The reaching distances (cm) from the three directions were averaged together and then normalized to the leg length of the stance leg (cm). The outcome variable, normalized maximum reaching distance (MAXD), was represented as a percentage value representing the distance as a % of leg length.
Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Dec 2010

First posted28 Sep 2010 (estimated)
Study startSep 2010
Primary completionSep 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ankle SprainStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01210612
Sponsor's protocol ID: UTHSC-12
Status last verified: Jul 2024
First submitted: 23 Jun 2010
Last updated: 13 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Recruiting
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains

All Ankle Sprain trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Five-Toed Socks on Postural Control Among Active Individuals Who Have Chronic Ankle Instabilities
ClinicalTrials.gov ID: NCT01210612
Acronym / sponsor ID: UTHSC-12
Conditions: Ankle Sprain
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: University of Toledo Health Science CampusUniversity, hospital or other
Study start: Sep 2010
Primary completion: Sep 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 28 Sep 2010 (estimated)
Results: Posted 13 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Without Unilateral CAI	Active comparator	Device: Unilateral CAIIndividuals with no history of chronic ankle instability (CAI)
With Unilateral CAI	Experimental	Device: Unilateral CAIIndividuals with a history of chronic ankle instability (CAI) that is affecting only one limb

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

member of university community
All subjects will be physically active (at least 30 minutes of sustained exercise 3 times/week

Key exclusion criteria (4 listed)

history of: knee or hip musculoskeletal injury or surgery
history of: fracture or dislocation of the testing ankle or leg
neurological problems
vestibular disorders or concussions within the last 6 months

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
Unilateral CAIfive-toed socks usage	Device	With Unilateral CAI, Without Unilateral CAI

Primary outcome

The Primary Outcome Measurement for This Study Was to Determine Differences in Center of Pressure (COP) and Static Postural Control Patterns in Individuals With and Without CAI During the Single Limb Balance Test.
Time frame: 3 weeks
Participants were recruited to complete three testing sessions, separated by approximately one week. The participants were tested while wearing five-toed socks. Static postural control was assessed on a force plate (model 4060NC; Bertec Corp. Inc., Columbus, OH) with the subject in a single-limb stance. Center of Pressure (COP) data were sampled at 50Hz. The subjects completed three 15-second trials with a one-minute rest between trials. Motion Monitor software (Innovative Sports Training, Inc., Chicago, IL) collected COP data during the single-limb stance test. The primary outcome was COP-Velocity (cm/sec).

1 secondary outcome

Reaching Distances
Time frame: 3 weeks

Results and safety

Results posted to the registry on 13 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
With Unilateral CAI	23	23
Without Unilateral CAI	30	28

Primary outcome: The Primary Outcome Measurement for This Study Was to Determine Differences in Center of Pressure (COP) and Static Postural Control Patterns in Individuals With and Without CAI During the Single Limb Balance Test.

Time frame: 3 weeks. Mean (Standard Deviation). Unit: COP-Velocity (cm/sec)

Measure	With Unilateral CAI n = 23	Without Unilateral CAI n = 28
Eyes Open	0.61 (0.27)	0.55 (0.21)
Eyes Closed	1.31 (0.38)	1.26 (0.34)

Population analysed: In published data by the lab director in which the dependant variable was normalized reaching distance on the SEBT, CAI subjects experienced a significantly reduced anterior reaching direction on their injured side compared to the Control group. Based on these data, to achieve a power level of 0.80, fifteen subjects in each group will be needed.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
With Unilateral CAI	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Without Unilateral CAI	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): The day-to-day diurnal effect has been recognized as an important factor to consider when measuring postural control. We, however, did not consider day-to-day influences in postural control. This may have influenced the data we have collected.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ankle Sprain

Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Recruiting
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains

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.

Phillip Gribble principal investigator

University of Toledo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Unilateral CAI in people with Ankle Sprain, run by University of Toledo Health Science Campus 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 2 inclusion and 4 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 13 Aug 2024. 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?

Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Primary Outcome Measurement for This Study Was to Determine Differences in Center of Pressure (COP) and Static Postural Control Patterns in Individuals With and Without CAI During the Single Limb Balance Test. (time frame: 3 weeks). 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 NCT01210612.

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 13 Aug 2024; AzTrials last refreshed its copy on 5 Nov 2026.