Ankle InjuryPhase 1NCT00432705
Changes in Unstable Ankles After Balance Training
A Phase 1 study testing Checking stability of ankle in people with Ankle Injury, run by University of North Carolina, Charlotte.
Trial summary
This study is evaluating reflex board training to see if it will help people who frequently roll their ankles. We are investigating several tests that evaluate the ability of the neuromuscular system to control ankle movement. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Injury
- What is being tested?
- Checking stability of ankle
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Sep 2007
- Phase
- Phase 1
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- chronically unstable ankles with a history of at least 2 ankle sprains in the past year, M/F 18-30, healthy
Who cannot join
- ankle sprain within past 6 months, any chronic lower extremity injury or condition, neurological condition, balance-inner ear or vestibular condition, any other condition that would interfere with testing
About this study
Official title: Modulation of Sensorimotor Measures in Chronically Unstable Ankles
This study is evaluating reflex board training to see if it will help people who frequently roll their ankles. We are investigating several tests that evaluate the ability of the neuromuscular system to control ankle movement. This study is in 2 parts:Part 1 looks at changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex training. It is thought that the reflex training will improve measures of static and dynamic balance as well as spinal reflex measures.
Read the detailed description
Research has utilized multiple measures in an effort to detect chronic ankle instability (CAI). Recently, investigations have focused on assessment of sensorimotor function in those who suffer from CAI. These measures have included traditional and functional postural control variables, as well as measures of joint position sense, neuromuscular control and recruitment, and nerve conduction velocity. This study seeks to modulate sensorimotor measures through both short- and long-term reflex training. This information may help to better assess sensorimotor deficits associated with CAI, to focus future research, evaluate rehabilitation protocols and to improve our understanding of this chronic disability.
- Conditions
- Ankle Injury
- Being tested
- Checking stability of ankle
- Keywords
- ankle, sensorimotor, reflex, training
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checking stability of ankleProcedure or surgery
Also called Flexibility study
Flexing and walking
What is being measured
The primary outcome is the main question the study is designed to answer.
postural control
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuryStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Charlotte
- Sponsor type
- University, hospital or other
- Investigators
- JoEllen M. Sefton, MS, ATC, CMT, Principal investigator, UNC Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432705
- Sponsor's protocol ID
- 05-11-34-CAI-B
- Status last verified
- Jul 2009
- First submitted
- 6 Feb 2007
- Last updated
- 22 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Sensorimotor Measures in Chronically Unstable Ankles
- ClinicalTrials.gov ID
- NCT00432705
- Acronym / sponsor ID
- 05-11-34-CAI-B
- Conditions
- Ankle Injury
- Keywords
- ankle, sensorimotor, reflex, training
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of North Carolina, CharlotteUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 8 Feb 2007 (estimated)
- 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.
This study is evaluating reflex board training to see if it will help people who frequently roll their ankles. We are investigating several tests that evaluate the ability of the neuromuscular system to control ankle movement. This study is in 2 parts:Part 1 looks at changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex training. It is thought that the reflex training will improve measures of static and dynamic balance as well as spinal reflex measures.
Detailed description
Research has utilized multiple measures in an effort to detect chronic ankle instability (CAI). Recently, investigations have focused on assessment of sensorimotor function in those who suffer from CAI. These measures have included traditional and functional postural control variables, as well as measures of joint position sense, neuromuscular control and recruitment, and nerve conduction velocity. This study seeks to modulate sensorimotor measures through both short- and long-term reflex training. This information may help to better assess sensorimotor deficits associated with CAI, to focus future research, evaluate rehabilitation protocols and to improve our understanding of this chronic disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- chronically unstable ankles with a history of at least 2 ankle sprains in the past year, M/F 18-30, healthy
Key exclusion criteria (1 listed)
- ankle sprain within past 6 months, any chronic lower extremity injury or condition, neurological condition, balance-inner ear or vestibular condition, any other condition that would interfere with testing
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 |
|---|---|---|
| Checking stability of ankleAlso: Flexibility studyFlexing and walking | Procedure or surgery | – |
Primary outcome
postural control
Time frame: 12 months
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 22 Jul 2009.
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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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.
JoEllen M. Sefton, MS, ATC, CMT principal investigator
UNC Charlotte
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Checking stability of ankle in people with Ankle Injury, run by University of North Carolina, Charlotte.
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 1 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 22 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postural control (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2009.