NCT07084220

Brief Summary

Purpose of the Study: The purpose of this study is to evaluate the effects of performing various cognitive tasks on balance in individuals with chronic ankle instability and healthy controls. Three different cognitive tasks will be performed while participants balance on one limb. Chronic ankle instability is defined as having a history of at least one ankle sprain and having residual effects. The specific aims of this study are to:

  1. 1.Determine if performing the cognitive tasks effect single limb balancing.
  2. 2.Determine which cognitive task, if any, has the greatest effect on single limb balance.
  3. 3.Each trial will last 1 minute. There will be at least a 30 second rest period between trials.
  4. 4.You will perform 3 trials of each cognitive task prior to moving on to the next task. There will be a 5 minute rest between cognitive tasks.
  5. 5.You will complete all testing on one limb (counterbalanced) prior to moving to the other limb.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
Last Updated

July 24, 2025

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

July 16, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

dual-taskanklebalance

Outcome Measures

Primary Outcomes (1)

  • Balance

    Force plate derived measures (center of pressure and time to boundary) will be collected.

    30 second trials

Secondary Outcomes (1)

  • Cognitive errors

    30 seconds

Study Arms (2)

Healthy control

* No previous history of ankle sprain on either limb * A score lower than 10 on the Identification of Functional Ankle Instability * Between 18-40 years old * Lower extremity injury-free for at least 3 months * No previous history of foot or ankle surgery on either limb * No known history of known foot or ankle fracture on either limb * No known neurological or vestibular disorders, or other medical conditions affecting balance, including ear infections * Does not have diabetes mellitus * No self-reported disability due to lower extremity pathology

Chronic ankle instability

* Between 18-40 years old * Lower extremity injury-free for at least 3 months * No previous history of foot or ankle surgery on either limb * No known history of known foot or ankle fracture on either limb * No known neurological or vestibular disorders, or other medical conditions affecting balance, including ear infections * Does not have diabetes mellitus * No self-reported disability due to lower extremity pathology * A previous history of at least 1 lateral ankle sprain as reported on the Modified Ankle Instability Index * A score of 10 or higher on the Identification of Functional Ankle Instability

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

University and surrounding community

You may qualify if:

  • Between 18-40 years old
  • Lower extremity injury-free for at least 3 months
  • No previous history of foot or ankle surgery on either limb
  • No known history of known foot or ankle fracture on either limb
  • No known neurological or vestibular disorders, or other medical conditions affecting balance, including ear infections
  • Does not have diabetes mellitus
  • No self-reported disability due to lower extremity pathology
  • No previous history of ankle sprain on either limb as reported on the Modified Ankle Instability Index questionnaire
  • A score lower than 10 on the Identification of Functional Ankle Instability questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burdick Hall

Towson, Maryland, 21252, United States

Location

Related Publications (1)

  • Rahnama L, Salavati M, Akhbari B, Mazaheri M. Attentional demands and postural control in athletes with and without functional ankle instability. J Orthop Sports Phys Ther. 2010 Mar;40(3):180-7. doi: 10.2519/jospt.2010.3188.

    PMID: 20195021BACKGROUND

Study Officials

  • Lisa Custer, Ph.D, ATC

    Towson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 24, 2025

Study Start

August 18, 2019

Primary Completion

January 21, 2020

Study Completion

July 31, 2020

Last Updated

July 24, 2025

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Data is available upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 1 year after publication with no end date

Locations