Chronic Ankle InstabilityPhase 2/3NCT02533037
Effects Of Rehabilitation Incorporating Gait Training On Clinical Measures Associated With Chronic Ankle Instability
A Phase 2/3 study testing Traditional Instability Tools and Ankle Destabilization Shoes in people with Chronic Ankle Instability, run by University of Virginia.
Trial summary
This is a randomized controlled trial (RCT) regarding the conservative treatment of chronic ankle instability (CAI) with an impairment based rehabilitation program. Individuals with CAI have deficits in neuromuscular control and altered gait patterns. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Traditional Instability Tools and Ankle Destabilization Shoes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Jul 2014
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- CAI with a history of recurrent ankle sprains, with the first sprain occurring longer than 12 months ago. Participants will have lingering symptoms, and disability, but have not actively sought treatment for their CAI
- All participants will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week.
Who cannot join
- Neurological or vestibular disorders affecting balance
- Currently seeking medical care for CAI
- History of prior ankle surgery
- History of ankle sprain within the past 6 weeks
- History of ankle fracture
- Diabetes mellitus
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- Current self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function
- Lumbosacral radiculopathy
- Pregnant
- Soft tissue disorders including Marfan's syndrome and Ehlers-Dandros syndrome
About this study
This is a randomized controlled trial (RCT) regarding the conservative treatment of chronic ankle instability (CAI) with an impairment based rehabilitation program. Individuals with CAI have deficits in neuromuscular control and altered gait patterns. Ankle destabilization shoes are used clinically and may improve neuromuscular control by increasing lower extremity muscle activation, which may improve gait patterns. The investigators' purpose is to determine whether a 4-week rehabilitation program that includes ankle destabilization shoes (experimental) has beneficial effects on self-reported function and ankle gait kinematics compared to traditional rehabilitation without destabilization shoes (control) in CAI patients. In addition, the investigators will compare ankle strength and balance between CAI patients and healthy individuals with no history of ankle injury prior to the 4-week rehabilitation. The investigators hypothesize the experimental group will have greater improvement in self-reported function and frontal and sagittal plane kinematics during walking compared to the control group. In addition, the investigators hypothesize that patients with CAI will have a decrease in ankle strength and balance when compared to healthy individuals. The design is a single-blinded randomized controlled trial. Forty CAI patients will complete baseline self-reported function questionnaires and walking gait trials and then be randomized into control and experimental groups. Both groups will complete 4-weeks of supervised rehabilitation with or without destabilization shoes and then repeat the questionnaires and walking trials.
- Conditions
- Chronic Ankle Instability
- Being tested
- Traditional Instability Tools, Ankle Destabilization Shoes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Instability ToolsOther
Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools.
Ankle Destabilization ShoesOther
Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use ankle destabilization shoes.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Instability Tools | Active comparator | Participants will use traditional instability tools during the impairment-based rehabilitation intervention. Receives: Other: Traditional Instability Tools |
| Ankle destabilization shoes | Experimental | Participants will use ankle destabilization shoes during the impairment-based rehabilitation intervention. Receives: Other: Ankle Destabilization Shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure questionnaire
Scores range from 100%(no decrease in function) to 0%(complete loss of function)
Measured: after 4-weeks of rehabilitation
Secondary outcomes (8)
Changes from baseline in ankle range of motion measured in degrees
Four different ankle ranges of motion will be measured using a bubble inclinometer
Measured: after 4-weeks of rehabilitation
Changes from baseline in ankle maximum voluntary isometric strength
Ankle maximum voluntary isometric strength will be measured during five different ankle positions using a hand-held dynamometer.
Measured: after 4-weeks of rehabilitation
Changes from baseline in balance
Static balance will be measured by participants standing on one limb on a forceplate to measure the participant's center of pressure.
Measured: after 4-weeks of rehabilitation
Changes from baseline in lower extremity electromyography during ankle maximal voluntary isometric strength testing
Lower extremity electormyography during maximal isometric strength testing will be measured using surface EMG electrodes over the peroneus brevis, peroneus longus, anterior tibialis, and medial gastrocnemius muscles.
Measured: after 4-weeks of rehabilitation
Changes from baseline in lower extremity electromyography during balance
Lower extremity electormyography during balance testing will be measured using surface EMG electrodes over the peroneus brevis, peroneus longus, anterior tibialis, and medial gastrocnemius muscles.
Measured: after 4-weeks of rehabilitation
Changes from baseline in lower extremity kinematics during walking
Ankle, knee, and hip motion during walking measured by a 3D motion capture system
Measured: after 4-weeks of rehabilitation
Changes from baseline in lower extremity kinetics during walking
Ankle, knee, and hip moments during walking measured by a 3D motion capture system
Measured: after 4-weeks of rehabilitation
Changes from baseline in lower extremity surface electromyography during walking
Lower extremity electormyography during walking will be measured using surface EMG electrodes over the peroneus brevis, peroneus longus, anterior tibialis, and medial gastrocnemius muscles.
Measured: after 4-weeks of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Hertel, PhD, ATC, University of Virginia
- Investigators
- Jay Hertel, PhD, ATC, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533037
- Sponsor's protocol ID
- 16992
- Status last verified
- Aug 2015
- First submitted
- 21 Aug 2015
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Rehabilitation Incorporating Gait Training On Clinical Measures Associated With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT02533037
- Acronym / sponsor ID
- 16992
- Conditions
- Chronic Ankle Instability
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Aug 2015 (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 is a randomized controlled trial (RCT) regarding the conservative treatment of chronic ankle instability (CAI) with an impairment based rehabilitation program. Individuals with CAI have deficits in neuromuscular control and altered gait patterns. Ankle destabilization shoes are used clinically and may improve neuromuscular control by increasing lower extremity muscle activation, which may improve gait patterns. The investigators' purpose is to determine whether a 4-week rehabilitation program that includes ankle destabilization shoes (experimental) has beneficial effects on self-reported function and ankle gait kinematics compared to traditional rehabilitation without destabilization shoes (control) in CAI patients. In addition, the investigators will compare ankle strength and balance between CAI patients and healthy individuals with no history of ankle injury prior to the 4-week rehabilitation. The investigators hypothesize the experimental group will have greater improvement in self-reported function and frontal and sagittal plane kinematics during walking compared to the control group. In addition, the investigators hypothesize that patients with CAI will have a decrease in ankle strength and balance when compared to healthy individuals. The design is a single-blinded randomized controlled trial. Forty CAI patients will complete baseline self-reported function questionnaires and walking gait trials and then be randomized into control and experimental groups. Both groups will complete 4-weeks of supervised rehabilitation with or without destabilization shoes and then repeat the questionnaires and walking trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Instability Tools | Active comparator | Other: Traditional Instability ToolsParticipants will use traditional instability tools during the impairment-based rehabilitation intervention. |
| Ankle destabilization shoes | Experimental | Other: Ankle Destabilization ShoesParticipants will use ankle destabilization shoes during the impairment-based rehabilitation intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- CAI with a history of recurrent ankle sprains, with the first sprain occurring longer than 12 months ago. Participants will have lingering symptoms, and disability, but have not actively sought treatment for their CAI
- All participants will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week.
Key exclusion criteria (10 listed)
- Neurological or vestibular disorders affecting balance
- Currently seeking medical care for CAI
- History of prior ankle surgery
- History of ankle sprain within the past 6 weeks
- History of ankle fracture
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 |
|---|---|---|
| Traditional Instability ToolsParticipants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools. | Other | Traditional Instability Tools |
| Ankle Destabilization ShoesParticipants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use ankle destabilization shoes. | Other | Ankle destabilization shoes |
Primary outcome
Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure questionnaire
Time frame: after 4-weeks of rehabilitation
Scores range from 100%(no decrease in function) to 0%(complete loss of function)
8 secondary outcomes
Changes from baseline in ankle range of motion measured in degrees
Time frame: after 4-weeks of rehabilitation
Changes from baseline in ankle maximum voluntary isometric strength
Time frame: after 4-weeks of rehabilitation
Changes from baseline in balance
Time frame: after 4-weeks of rehabilitation
Changes from baseline in lower extremity electromyography during ankle maximal voluntary isometric strength testing
Time frame: after 4-weeks of rehabilitation
Changes from baseline in lower extremity electromyography during balance
Time frame: after 4-weeks of rehabilitation
Changes from baseline in lower extremity kinematics during walking
Time frame: after 4-weeks of rehabilitation
Changes from baseline in lower extremity kinetics during walking
Time frame: after 4-weeks of rehabilitation
Changes from baseline in lower extremity surface electromyography during walking
Time frame: after 4-weeks of rehabilitation
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 26 Aug 2015.
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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.
Jay Hertel, PhD, ATC principal investigator
University of Virginia
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Traditional Instability Tools and Ankle Destabilization Shoes in people with Chronic Ankle Instability, run by University of Virginia.
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 2 inclusion and 10 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 26 Aug 2015. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure questionnaire (time frame: after 4-weeks of rehabilitation). 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 26 Aug 2015.