Ankle SprainsPhase 3NCT03507803
Effects of Gait Biofeedback and Impairment-based Rehabilitation in Individuals With Chronic Ankle Instability
A Phase 3 study testing Gait Biofeedback in people with Ankle Sprains and Ankle Injuries, run by University of Virginia at 1 site in United States.
Trial summary
Individuals with chronic ankle instability (CAI) have demonstrated altered gait patterns. Gait training may be necessary to address these alterations as protocols focusing solely on strength or balance have not been shown to impact walking gait. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Ankle Sprains, Ankle Injuries
- What is being tested?
- Gait Biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2018to Mar 2020
- Phase
- Phase 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- >1 Ankle Sprain (>12 months prior)
- Physically active (>1.5 hr/week)
- > 10 on Identification of Functional Ankle Instability (IdFAI)
- < 90 Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)
- < 85 FAAM Sport
Who cannot join
- Hx of LE fracture
- Hx of LE surgery
- Hx of ankle sprain within last 6 weeks
- Participating in physical therapy for ankle
- Multiple Sclerosis
- Marfan's Syndrome
Show all 11Show fewer
- Lumbosacral Radiculopathy
- Ehlers-Danlos Syndrome
- Diabetes Mellitus
- Pregnant (self-reported)
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22904
Rachel M Koldenhoven, MEd, 434-924-6184, rmk7ye@virginia.edu
About this study
Individuals with chronic ankle instability (CAI) have demonstrated altered gait patterns. Gait training may be necessary to address these alterations as protocols focusing solely on strength or balance have not been shown to impact walking gait. Biofeedback about the foot position during walking may help improve gait biomechanics. The purpose is to determine whether a 4-week rehabilitation program that includes biofeedback has beneficial effects on self-reported function and ankle gait kinematics compared to rehabilitation alone in people with CAI. The design is a single-blinded randomized controlled trial. Participants will complete baseline self-reported function questionnaires and walking gait trials and then be randomized to complete 4- weeks of supervised rehabilitation with or without audiovisual biofeedback. Follow up emails will ask for participant information about ankle health and to complete questionnaires about their ankle for 6 months and 12 months after completing rehabilitation.
Read the detailed description
This study will require 10 visits for all participants. Both groups will participate in baseline and follow-up gait assessments involving walking on a treadmill at 1.34 m/s. Follow-up visits will be conducted within 72 hours of the participant's final rehabilitation session. Using a rigid cluster marker setup, reflective markers will be placed on the upper back, sacrum, and bilaterally on the thigh, shank, rearfoot, and forefoot. A 5-minute familiarization period will be completed to ensure participants are comfortable and walking as normally as possible. Following the familiarization period, 1-minute of continuous gait data will be collected. The data collected during baseline and follow-up gait assessments will be used to analyze the primary and secondary outcome measures for kinematics. Participants will also complete the patient reported outcomes (FAAM ADL \& Sport Subscale) at the baseline and follow-up visits.
Impairment-based Rehabilitation:
Four weeks of supervised rehabilitation (8 sessions) will be provided to both groups. This rehabilitation paradigm has been previously reported by Donovan and Hertel. Impairment-based rehabilitation involves identifying and treating deficits in 4 broad domains including range of motion (ROM), strength, balance, and functional exercises by using an "asses, treat, re-assess" approach. Previously reported intervention methods will be used in this study. The clinician administering the rehabilitation will be blinded to the subjects' intervention group status.
Intervention:
Gait training using visual feedback for frontal plane ankle position at initial contact (IC) will be projected onto a screen in front of the treadmill.
Gait Training Protocol:
The goal of this protocol is to improve the position of the ankle at IC using visual feedback gait training over the course of 4 weeks. The intervention group will participate in 2 sessions of gait training per week for 4 weeks using intermittent feedback described by Noehren et al. The Motion Monitor is a software system uses body movements to provide visual feedback to the participant by using information from retroreflective markers on the body that are captured by the cameras. The software will use the position of the rearfoot marker cluster in relation to the shank marker cluster to determine the rearfoot inversion angle at IC and provide visual biofeedback information for the next step. Visual feedback in the shape of a line will be displayed as an image projected onto a screen in front of the treadmill representing frontal plane inversion angle. The line will adjust (similar to a teeter-totter) according to the position of the foot and will change color accordingly. When the ankle position is too inverted, the line will turn red and an audio tone will be heard by the participant. When the ankle position is in a good position, the line will turn green and the tone will not be heard.
- Conditions
- Ankle Sprains, Ankle Injuries
- Being tested
- Gait Biofeedback
- Keywords
- Gait training, Walking
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait BiofeedbackOther
Feedback will appear on screen in front of participants during walking. If their foot is too inverted (determined by researcher) the object on the screen will turn red and an audio tone will be heard. If the participant corrects the foot position, the object will turn green and the audio tone will not be heard.
| Study group | Role | What they receive |
|---|---|---|
| Gait Biofeedback | Experimental | This group will receive audiovisual feedback about the position of their foot during walking. Feedback will be provided over 8 total sessions. Receives: Other: Gait Biofeedback |
| Control | No intervention | This arm will not receive any audiovisual feedback about the position of their foot during walking. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Ankle Frontal Plane Angle During Gait
Ankle frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Measured: Baseline, 4 weeks
Secondary outcomes (19)
Change from Baseline Ankle Sagittal Plane Angle During Gait
Ankle sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Measured: Baseline, 4 weeks
Change from Baseline Ankle Transverse Plane Angle During Gait
Ankle transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Measured: Baseline, 4 weeks
Change from Baseline Hip Frontal Plane Angle During Gait
Hip frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Measured: Baseline, 4 weeks
Change from Baseline Hip Sagittal Plane Angle During Gait
Hip sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Measured: Baseline, 4 weeks
Change from Baseline Hip Transverse Plane Angle During Gait
Hip transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Measured: Baseline, 4 weeks
Change from Baseline Knee Frontal Plane Angle During Gait
Knee frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Measured: Baseline, 4 weeks
Change from Baseline Knee Sagittal Plane Angle During Gait
Knee sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Measured: Baseline, 4 weeks
Change from Baseline Knee Transverse Plane Angle During Gait
Knee transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Measured: Baseline, 4 weeks
Change from Baseline Range of motion
Ankle range of motion will be assessed using a plastic goniometer
Measured: Baseline, 4 weeks
Change from Baseline Balance
Single limb balance with eyes open and eye closed conditions will be assessed using a Tekscan pressure mat
Measured: Baseline, 4 weeks
Change from Baseline Strength
Ankle and hip strength will be assessed using a handheld dynamometer in N
Measured: Baseline, 4 weeks
Change from Baseline Foot and Ankle Ability Measure (FAAM)
The Foot and Ankle Ability Measure (FAAM) for Activities of Daily Living total score will be assessed. The score will be assessed as a percentage. Scores closer to 100% indicate full ankle function. Lower percentage scores indicate ankle dysfunction.
Measured: Baseline, 4 weeks
Change from Baseline Foot and Ankle Ability Measure (FAAM) Sport
The Foot and Ankle Ability Measure (FAAM) Sport total score will be assessed. The score will be assessed as a percentage. Scores closer to 100% indicate full ankle function. Lower percentage scores indicate ankle dysfunction.
Measured: Baseline, 4 weeks
Change from Baseline Identification of Functional Ankle Instability (IdFAI)
The Identification of Functional Ankle Instability (IdFAI) total score will be assessed. Raw scores will be assessed. Higher scores indicate more ankle dysfunction. Lower scores indicate better ankle function.
Measured: Baseline, 4 weeks
Change from Baseline International Physical Activity Questionnaire
The International Physical Activity Questionnaire total score will be assessed. Higher scores represent increased physical activity.
Measured: Baseline, 4 weeks
Change from Baseline Tampa Scale if Kinesiophobia (TSK)
The Tampa Scale if Kinesiophobia (TSK) total score will be assessed. Lower scores indicate less kinesiophobia. Higher scores indicate higher amount of kinesiophobia.
Measured: Baseline, 4 weeks
Change from Baseline Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) total score will be assessed. The range will be from 0 to 100. Higher score indicates worse ankle pain. Lower score indicates better ankle pain.
Measured: Baseline, 4 weeks
The Global Rating of Change (GROC) Score
The Global Rating of Change (GROC) score will be assessed at the follow-up visit. A positive and higher score indicates the patient feels better than they did when they began the study. A score of 0 indicates no change from baseline. A negative and lower score indicates the patient feels worse than they did when they began the study.
Measured: 4 weeks
Change from Baseline Physical Activity
Fitbit Charge HR monitors will be worn by all participants for 4 weeks. Average daily steps will be analyzed.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start15 Feb 2018
- Primary completionMar 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized at the baseline visit to either the intervention or control group. The intervention group will receive gait biofeedback. Participants will remain within their designated allocation for the entire study.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
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 N Hertel, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507803
- Sponsor's protocol ID
- 20446
- Status last verified
- May 2018
- First submitted
- 15 Feb 2018
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537.
PubMed 20926721Delahunt E, Coughlan GF, Caulfield B, Nightingale EJ, Lin CW, Hiller CE. Inclusion criteria when investigating insufficiencies in chronic ankle instability. Med Sci Sports Exerc. 2010 Nov;42(11):2106-21. doi: 10.1249/MSS.0b013e3181de7a8a.
PubMed 20351590Mok KM, Fong DT, Krosshaug T, Engebretsen L, Hung AS, Yung PS, Chan KM. Kinematics analysis of ankle inversion ligamentous sprain injuries in sports: 2 cases during the 2008 Beijing Olympics. Am J Sports Med. 2011 Jul;39(7):1548-52. doi: 10.1177/0363546511399384. Epub 2011 Apr 1. No abstract available.
PubMed 21460069Fong DT, Ha SC, Mok KM, Chan CW, Chan KM. Kinematics analysis of ankle inversion ligamentous sprain injuries in sports: five cases from televised tennis competitions. Am J Sports Med. 2012 Nov;40(11):2627-32. doi: 10.1177/0363546512458259. Epub 2012 Sep 11.
PubMed 22967824Bonnel F, Toullec E, Mabit C, Tourne Y; Sofcot. Chronic ankle instability: biomechanics and pathomechanics of ligaments injury and associated lesions. Orthop Traumatol Surg Res. 2010 Jun;96(4):424-32. doi: 10.1016/j.otsr.2010.04.003. Epub 2010 May 20.
PubMed 20493797Chinn L, Dicharry J, Hertel J. Ankle kinematics of individuals with chronic ankle instability while walking and jogging on a treadmill in shoes. Phys Ther Sport. 2013 Nov;14(4):232-9. doi: 10.1016/j.ptsp.2012.10.001. Epub 2013 Apr 25.
PubMed 23623243Doherty C, Bleakley C, Hertel J, Caulfield B, Ryan J, Delahunt E. Recovery From a First-Time Lateral Ankle Sprain and the Predictors of Chronic Ankle Instability: A Prospective Cohort Analysis. Am J Sports Med. 2016 Apr;44(4):995-1003. doi: 10.1177/0363546516628870. Epub 2016 Feb 24.
PubMed 26912285Donovan L, Hart JM, Saliba SA, Park J, Feger MA, Herb CC, Hertel J. Rehabilitation for Chronic Ankle Instability With or Without Destabilization Devices: A Randomized Controlled Trial. J Athl Train. 2016 Mar;51(3):233-51. doi: 10.4085/1062-6050-51.3.09. Epub 2016 Mar 2.
PubMed 26934211Donovan L, Hart JM, Saliba S, Park J, Feger MA, Herb CC, Hertel J. Effects of ankle destabilization devices and rehabilitation on gait biomechanics in chronic ankle instability patients: A randomized controlled trial. Phys Ther Sport. 2016 Sep;21:46-56. doi: 10.1016/j.ptsp.2016.02.006. Epub 2016 Feb 27.
PubMed 27428534Donovan L, Hertel J. A new paradigm for rehabilitation of patients with chronic ankle instability. Phys Sportsmed. 2012 Nov;40(4):41-51. doi: 10.3810/psm.2012.11.1987.
PubMed 23306414Feger MA, Hertel J. Surface electromyography and plantar pressure changes with novel gait training device in participants with chronic ankle instability. Clin Biomech (Bristol). 2016 Aug;37:117-124. doi: 10.1016/j.clinbiomech.2016.07.002. Epub 2016 Jul 7.
PubMed 27423026Donovan L, Feger MA, Hart JM, Saliba S, Park J, Hertel J. Effects of an auditory biofeedback device on plantar pressure in patients with chronic ankle instability. Gait Posture. 2016 Feb;44:29-36. doi: 10.1016/j.gaitpost.2015.10.013. Epub 2015 Oct 27.
PubMed 27004629Koldenhoven RM, Feger MA, Fraser JJ, Saliba S, Hertel J. Surface electromyography and plantar pressure during walking in young adults with chronic ankle instability. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1060-70. doi: 10.1007/s00167-016-4015-3. Epub 2016 Feb 8.
PubMed 26856315Doherty C, Bleakley C, Hertel J, Caulfield B, Ryan J, Delahunt E. Locomotive biomechanics in persons with chronic ankle instability and lateral ankle sprain copers. J Sci Med Sport. 2016 Jul;19(7):524-30. doi: 10.1016/j.jsams.2015.07.010. Epub 2015 Jul 10.
PubMed 26296816Noehren B, Scholz J, Davis I. The effect of real-time gait retraining on hip kinematics, pain and function in subjects with patellofemoral pain syndrome. Br J Sports Med. 2011 Jul;45(9):691-6. doi: 10.1136/bjsm.2009.069112. Epub 2010 Jun 28.
PubMed 20584755
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gait Biofeedback and Impairment-based Rehabilitation in Individuals With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03507803
- Acronym / sponsor ID
- 20446
- Conditions
- Ankle Sprains, Ankle Injuries
- Keywords
- Gait training, Walking
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 25 Apr 2018 (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.
Individuals with chronic ankle instability (CAI) have demonstrated altered gait patterns. Gait training may be necessary to address these alterations as protocols focusing solely on strength or balance have not been shown to impact walking gait. Biofeedback about the foot position during walking may help improve gait biomechanics. The purpose is to determine whether a 4-week rehabilitation program that includes biofeedback has beneficial effects on self-reported function and ankle gait kinematics compared to rehabilitation alone in people with CAI. The design is a single-blinded randomized controlled trial. Participants will complete baseline self-reported function questionnaires and walking gait trials and then be randomized to complete 4- weeks of supervised rehabilitation with or without audiovisual biofeedback. Follow up emails will ask for participant information about ankle health and to complete questionnaires about their ankle for 6 months and 12 months after completing rehabilitation.
Detailed description
This study will require 10 visits for all participants. Both groups will participate in baseline and follow-up gait assessments involving walking on a treadmill at 1.34 m/s. Follow-up visits will be conducted within 72 hours of the participant's final rehabilitation session. Using a rigid cluster marker setup, reflective markers will be placed on the upper back, sacrum, and bilaterally on the thigh, shank, rearfoot, and forefoot. A 5-minute familiarization period will be completed to ensure participants are comfortable and walking as normally as possible. Following the familiarization period, 1-minute of continuous gait data will be collected. The data collected during baseline and follow-up gait assessments will be used to analyze the primary and secondary outcome measures for kinematics. Participants will also complete the patient reported outcomes (FAAM ADL \& Sport Subscale) at the baseline and follow-up visits.
Impairment-based Rehabilitation:
Four weeks of supervised rehabilitation (8 sessions) will be provided to both groups. This rehabilitation paradigm has been previously reported by Donovan and Hertel. Impairment-based rehabilitation involves identifying and treating deficits in 4 broad domains including range of motion (ROM), strength, balance, and functional exercises by using an "asses, treat, re-assess" approach. Previously reported intervention methods will be used in this study. The clinician administering the rehabilitation will be blinded to the subjects' intervention group status.
Intervention:
Gait training using visual feedback for frontal plane ankle position at initial contact (IC) will be projected onto a screen in front of the treadmill.
Gait Training Protocol:
The goal of this protocol is to improve the position of the ankle at IC using visual feedback gait training over the course of 4 weeks. The intervention group will participate in 2 sessions of gait training per week for 4 weeks using intermittent feedback described by Noehren et al. The Motion Monitor is a software system uses body movements to provide visual feedback to the participant by using information from retroreflective markers on the body that are captured by the cameras. The software will use the position of the rearfoot marker cluster in relation to the shank marker cluster to determine the rearfoot inversion angle at IC and provide visual biofeedback information for the next step. Visual feedback in the shape of a line will be displayed as an image projected onto a screen in front of the treadmill representing frontal plane inversion angle. The line will adjust (similar to a teeter-totter) according to the position of the foot and will change color accordingly. When the ankle position is too inverted, the line will turn red and an audio tone will be heard by the participant. When the ankle position is in a good position, the line will turn green and the tone will not be heard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Participants will be randomized at the baseline visit to either the intervention or control group. The intervention group will receive gait biofeedback. Participants will remain within their designated allocation for the entire study.
| Arm | Type | Receives |
|---|---|---|
| Gait Biofeedback | Experimental | Other: Gait BiofeedbackThis group will receive audiovisual feedback about the position of their foot during walking. Feedback will be provided over 8 total sessions. |
| Control | No intervention | –This arm will not receive any audiovisual feedback about the position of their foot during walking. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- >1 Ankle Sprain (>12 months prior)
- Physically active (>1.5 hr/week)
- > 10 on Identification of Functional Ankle Instability (IdFAI)
- < 90 Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)
- < 85 FAAM Sport
Key exclusion criteria (11 listed)
- Hx of LE fracture
- Hx of LE surgery
- Hx of ankle sprain within last 6 weeks
- Participating in physical therapy for ankle
- Multiple Sclerosis
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 |
|---|---|---|
| Gait BiofeedbackFeedback will appear on screen in front of participants during walking. If their foot is too inverted (determined by researcher) the object on the screen will turn red and an audio tone will be heard. If the participant corrects the foot position, the object will turn green and the audio tone will not be heard. | Other | Gait Biofeedback |
Primary outcome
Change from Baseline Ankle Frontal Plane Angle During Gait
Time frame: Baseline, 4 weeks
Ankle frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
19 secondary outcomes
Change from Baseline Ankle Sagittal Plane Angle During Gait
Time frame: Baseline, 4 weeks
Change from Baseline Ankle Transverse Plane Angle During Gait
Time frame: Baseline, 4 weeks
Change from Baseline Hip Frontal Plane Angle During Gait
Time frame: Baseline, 4 weeks
Change from Baseline Hip Sagittal Plane Angle During Gait
Time frame: Baseline, 4 weeks
Change from Baseline Hip Transverse Plane Angle During Gait
Time frame: Baseline, 4 weeks
Change from Baseline Knee Frontal Plane Angle During Gait
Time frame: Baseline, 4 weeks
Change from Baseline Knee Sagittal Plane Angle During Gait
Time frame: Baseline, 4 weeks
Change from Baseline Knee Transverse Plane Angle During Gait
Time frame: Baseline, 4 weeks
Change from Baseline Range of motion
Time frame: Baseline, 4 weeks
Change from Baseline Balance
Time frame: Baseline, 4 weeks
Change from Baseline Strength
Time frame: Baseline, 4 weeks
Change from Baseline Foot and Ankle Ability Measure (FAAM)
Time frame: Baseline, 4 weeks
Change from Baseline Foot and Ankle Ability Measure (FAAM) Sport
Time frame: Baseline, 4 weeks
Change from Baseline Identification of Functional Ankle Instability (IdFAI)
Time frame: Baseline, 4 weeks
Change from Baseline International Physical Activity Questionnaire
Time frame: Baseline, 4 weeks
Change from Baseline Tampa Scale if Kinesiophobia (TSK)
Time frame: Baseline, 4 weeks
Change from Baseline Visual Analog Scale (VAS)
Time frame: Baseline, 4 weeks
The Global Rating of Change (GROC) Score
Time frame: 4 weeks
Change from Baseline Physical Activity
Time frame: Baseline, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Background: PubMed 20926721Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537.
- Background: PubMed 20351590Delahunt E, Coughlan GF, Caulfield B, Nightingale EJ, Lin CW, Hiller CE. Inclusion criteria when investigating insufficiencies in chronic ankle instability. Med Sci Sports Exerc. 2010 Nov;42(11):2106-21. doi: 10.1249/MSS.0b013e3181de7a8a.
- Background: PubMed 21460069Mok KM, Fong DT, Krosshaug T, Engebretsen L, Hung AS, Yung PS, Chan KM. Kinematics analysis of ankle inversion ligamentous sprain injuries in sports: 2 cases during the 2008 Beijing Olympics. Am J Sports Med. 2011 Jul;39(7):1548-52. doi: 10.1177/0363546511399384. Epub 2011 Apr 1. No abstract available.
- Background: PubMed 22967824Fong DT, Ha SC, Mok KM, Chan CW, Chan KM. Kinematics analysis of ankle inversion ligamentous sprain injuries in sports: five cases from televised tennis competitions. Am J Sports Med. 2012 Nov;40(11):2627-32. doi: 10.1177/0363546512458259. Epub 2012 Sep 11.
- Background: PubMed 20493797Bonnel F, Toullec E, Mabit C, Tourne Y; Sofcot. Chronic ankle instability: biomechanics and pathomechanics of ligaments injury and associated lesions. Orthop Traumatol Surg Res. 2010 Jun;96(4):424-32. doi: 10.1016/j.otsr.2010.04.003. Epub 2010 May 20.
- Background: PubMed 23623243Chinn L, Dicharry J, Hertel J. Ankle kinematics of individuals with chronic ankle instability while walking and jogging on a treadmill in shoes. Phys Ther Sport. 2013 Nov;14(4):232-9. doi: 10.1016/j.ptsp.2012.10.001. Epub 2013 Apr 25.
- Background: PubMed 26912285Doherty C, Bleakley C, Hertel J, Caulfield B, Ryan J, Delahunt E. Recovery From a First-Time Lateral Ankle Sprain and the Predictors of Chronic Ankle Instability: A Prospective Cohort Analysis. Am J Sports Med. 2016 Apr;44(4):995-1003. doi: 10.1177/0363546516628870. Epub 2016 Feb 24.
- Background: PubMed 26934211Donovan L, Hart JM, Saliba SA, Park J, Feger MA, Herb CC, Hertel J. Rehabilitation for Chronic Ankle Instability With or Without Destabilization Devices: A Randomized Controlled Trial. J Athl Train. 2016 Mar;51(3):233-51. doi: 10.4085/1062-6050-51.3.09. Epub 2016 Mar 2.
- Background: PubMed 27428534Donovan L, Hart JM, Saliba S, Park J, Feger MA, Herb CC, Hertel J. Effects of ankle destabilization devices and rehabilitation on gait biomechanics in chronic ankle instability patients: A randomized controlled trial. Phys Ther Sport. 2016 Sep;21:46-56. doi: 10.1016/j.ptsp.2016.02.006. Epub 2016 Feb 27.
- Background: PubMed 23306414Donovan L, Hertel J. A new paradigm for rehabilitation of patients with chronic ankle instability. Phys Sportsmed. 2012 Nov;40(4):41-51. doi: 10.3810/psm.2012.11.1987.
- Background: PubMed 27423026Feger MA, Hertel J. Surface electromyography and plantar pressure changes with novel gait training device in participants with chronic ankle instability. Clin Biomech (Bristol). 2016 Aug;37:117-124. doi: 10.1016/j.clinbiomech.2016.07.002. Epub 2016 Jul 7.
- Background: PubMed 27004629Donovan L, Feger MA, Hart JM, Saliba S, Park J, Hertel J. Effects of an auditory biofeedback device on plantar pressure in patients with chronic ankle instability. Gait Posture. 2016 Feb;44:29-36. doi: 10.1016/j.gaitpost.2015.10.013. Epub 2015 Oct 27.
- Individual participant dataSharing planned: No
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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 N Hertel, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gait Biofeedback in people with Ankle Sprains and Ankle Injuries, run by University of Virginia 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 May 2018. 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.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel M Koldenhoven, MEd (434-924-6184, rmk7ye@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Ankle Frontal Plane Angle During Gait (time frame: Baseline, 4 weeks). 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 NCT03507803, which also lists 17 linked publications.
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 16 May 2018.