Novel Sock Design on Ankle and Postural Stability

NCT06871085 | Recruiting

• 1 other identifier: STUDY00007246
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ankle Stability; Postural Stability

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Immediately after intervention

Study Arms (1)

Sock

EXPERIMENTAL

Ankle and postural stability will be evaluated with and without use of a novel stability sock

Device: Stability Sock

Interventions

Stability Sock DEVICE

Use of a stability sock

Sock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Experienced radicular symptoms down either lower extremity
• Had any allergies to the sock material used in the study
• % nylon
• % polyester
• % elastane
• Is currently pregnant

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 34096370 BACKGROUND

Central Study Contacts

William J Hanney, PhD

CONTACT

407-823-0217; william.j.hanney@ucf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: March 11, 2025
• Study Start: March 3, 2025
• Primary Completion: August 25, 2025
• Study Completion: February 2, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)