Chronic Ankle Instability, CAINCT07084220
The Effect of Cognitive Tasks on Single Limb Balance
An observational study of Chronic Ankle Instability, CAI and Healthy Participants, run by Towson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability, CAI, Healthy Participants
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2019to 31 Jul 2020
- Phase
- Observational
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: University and surrounding community
Who may be able to join
- 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
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- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Determine if performing the cognitive tasks effect single limb balancing.
- Determine which cognitive task, if any, has the greatest effect on single limb balance.
Read more
Participants will perform single-limb balancing with eyes open on the force plate while performing one of the four cognitive tasks. You will start with the control condition, the order of cognitive tasks will be random. Testing will occur on both limbs.
- Each trial will last 1 minute. There will be at least a 30 second rest period between trials.
- 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.
- You will complete all testing on one limb (counterbalanced) prior to moving to the other limb.
- Keywords
- dual-task, ankle, balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Force plate derived measures (center of pressure and time to boundary) will be collected.
Measured: 30 second trials
Secondary outcomes (1)
Cognitive errors
The number of cognitive errors during cognitive tasks.
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start18 Aug 2019
- Primary completion21 Jan 2020
- Study completion31 Jul 2020
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 Chronic Ankle Instability, CAIStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Towson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Custer, Towson University
- Investigators
- Lisa Custer, Ph.D, ATC, Principal investigator, Towson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084220
- Sponsor's protocol ID
- 1907054099
- Status last verified
- Aug 2019
- First submitted
- 16 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is available upon request
Publications
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.
PubMed 20195021
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Tasks on Single Limb Balance
- ClinicalTrials.gov ID
- NCT07084220
- Acronym / sponsor ID
- 1907054099
- Keywords
- dual-task, ankle, balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Towson UniversityUniversity, hospital or other
- Study start
- 18 Aug 2019 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 24 Jul 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.
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:
- Determine if performing the cognitive tasks effect single limb balancing.
- Determine which cognitive task, if any, has the greatest effect on single limb balance.
Participants will perform single-limb balancing with eyes open on the force plate while performing one of the four cognitive tasks. You will start with the control condition, the order of cognitive tasks will be random. Testing will occur on both limbs.
- Each trial will last 1 minute. There will be at least a 30 second rest period between trials.
- 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.
- You will complete all testing on one limb (counterbalanced) prior to moving to the other limb.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University and surrounding community
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Balance
Time frame: 30 second trials
Force plate derived measures (center of pressure and time to boundary) will be collected.
1 secondary outcome
Cognitive errors
Time frame: 30 seconds
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 24 Jul 2025.
- Background: PubMed 20195021Rahnama 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.
- Individual participant dataSharing planned: Yes. Data is 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.
Lisa Custer, Ph.D, ATC principal investigator
Towson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ankle Instability, CAI and Healthy Participants, run by Towson University 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 9 inclusion and 1 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 24 Jul 2025. 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?
Balance (time frame: 30 second trials). 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 NCT07084220, 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 24 Jul 2025.