Effects of Gait Biofeedback and Impairment-based Rehabilitation in Individuals With Chronic Ankle Instability
NCT ID: NCT03507803
Last Updated: 2018-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2018-02-15
2020-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Gait Biofeedback
This group will receive audiovisual feedback about the position of their foot during walking. Feedback will be provided over 8 total sessions.
Gait Biofeedback
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.
Control
This arm will not receive any audiovisual feedback about the position of their foot during walking.
No interventions assigned to this group
Interventions
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Gait Biofeedback
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Hx of LE surgery
* Hx of ankle sprain within last 6 weeks
* Participating in physical therapy for ankle
* Multiple Sclerosis
* Marfan's Syndrome
* Lumbosacral Radiculopathy
* Ehlers-Danlos Syndrome
* Diabetes Mellitus
* Pregnant (self-reported)
* Unable to provide informed consent
18 Years
30 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Jay Hertel, PhD, ATC
Principal Investigator
Principal Investigators
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Jay N Hertel, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Delahunt 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.
Mok 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.
Fong 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.
Bonnel 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.
Chinn 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.
Doherty 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.
Donovan 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.
Donovan 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.
Donovan 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.
Feger 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.
Donovan 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.
Koldenhoven 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.
Doherty 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.
Noehren 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.
McKeon PO, Paolini G, Ingersoll CD, Kerrigan DC, Saliba EN, Bennett BC, Hertel J. Effects of balance training on gait parameters in patients with chronic ankle instability: a randomized controlled trial. Clin Rehabil. 2009 Jul;23(7):609-21. doi: 10.1177/0269215509102954. Epub 2009 May 15.
Davis IS, Futrell E. Gait Retraining: Altering the Fingerprint of Gait. Phys Med Rehabil Clin N Am. 2016 Feb;27(1):339-55. doi: 10.1016/j.pmr.2015.09.002.
Other Identifiers
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20446
Identifier Type: -
Identifier Source: org_study_id
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