Trial Outcomes & Findings for The Effect of Five-Toed Socks on Postural Control Among Active Individuals Who Have Chronic Ankle Instabilities (NCT NCT01210612)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

3 weeks

Results posted on

2024-08-13

Participant Flow

Dates of the recruitment period was from January 2009 to September 2010. Data was collected at Athletic Training Research Laboratory located in room 1406A Health Science and Human Service Building, University of Toledo, Toledo, OH 43606. Subjects were approached in groups during classes at the University of Toledo.

Enrolled participants were selected based on the inclusion and exclusion criteria in this study, therefore no participants were excluded following participant enrollment, but prior to group assignment.

Participant milestones

Participant milestones
Measure	With Unilateral CAI five-toed socks : five-toed socks usage	Without Unilateral CAI five-toed socks : five-toed socks usage
Overall Study STARTED	23	30
Overall Study COMPLETED	23	28
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	With Unilateral CAI five-toed socks : five-toed socks usage	Without Unilateral CAI five-toed socks : five-toed socks usage
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	With Unilateral CAI n=23 Participants five-toed socks : five-toed socks usage	Without Unilateral CAI n=30 Participants five-toed socks : five-toed socks usage	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	30 Participants n=7 Participants	53 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	22.3 years STANDARD_DEVIATION 3.3 • n=5 Participants	22.7 years STANDARD_DEVIATION 3.0 • n=7 Participants	22.5 years STANDARD_DEVIATION 3.2 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	30 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: 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.

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).

Outcome measures

Outcome measures
Measure	With Unilateral CAI n=23 Participants Participants with unilateral CAI while wearing five-toed socks	Without Unilateral CAI n=28 Participants Participants without unilateral CAI while wearing five-toed socks
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. Eyes Open	0.61 COP-Velocity (cm/sec) Standard Deviation 0.27	0.55 COP-Velocity (cm/sec) Standard Deviation 0.21
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. Eyes Closed	1.31 COP-Velocity (cm/sec) Standard Deviation 0.38	1.26 COP-Velocity (cm/sec) Standard Deviation 0.34

SECONDARY outcome

Timeframe: 3 weeks

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.

Outcome measures

Outcome measures
Measure	With Unilateral CAI n=23 Participants Participants with unilateral CAI while wearing five-toed socks	Without Unilateral CAI n=28 Participants Participants without unilateral CAI while wearing five-toed socks
Reaching Distances	66.1 MAXD (% of leg length) Standard Deviation 6.4	71.4 MAXD (% of leg length) Standard Deviation 5.8

Adverse Events

With Unilateral CAI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Without Unilateral CAI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Phillip Gribble

University of Toledo Health Science Campus

Phone: (419) 530-2691

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place