Effects of Gait Biofeedback and Impairment-based Rehabilitation in Individuals With Chronic Ankle Instability

NCT03507803 | Unknown Phase 3

• 1 other identifier: 20446
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ankle Sprains; Ankle Injuries

Keywords

Gait training; Walking

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Ankle Frontal Plane Angle During Gait

  Ankle frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.

  Baseline, 4 weeks

Secondary Outcomes (19)

• Change from Baseline Ankle Sagittal Plane Angle During Gait

  Baseline, 4 weeks

• Change from Baseline Ankle Transverse Plane Angle During Gait

  Baseline, 4 weeks

• Change from Baseline Hip Frontal Plane Angle During Gait

  Baseline, 4 weeks

• Change from Baseline Hip Sagittal Plane Angle During Gait

  Baseline, 4 weeks

• Change from Baseline Hip Transverse Plane Angle During Gait

  Baseline, 4 weeks

Study Arms (2)

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.

Other: Gait Biofeedback

Control

NO INTERVENTION

This arm will not receive any audiovisual feedback about the position of their foot during walking.

Interventions

Gait Biofeedback OTHER

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.

Gait Biofeedback

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \>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

You may not qualify if:

• 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
• Lumbosacral Radiculopathy
• Ehlers-Danlos Syndrome
• Diabetes Mellitus
• Pregnant (self-reported)
• Unable to provide informed consent

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

RECRUITING

Related Publications (17)

• 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.

  PMID: 20926721 BACKGROUND

• 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.

  PMID: 20351590 BACKGROUND

• 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.

  PMID: 21460069 BACKGROUND

• 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.

  PMID: 22967824 BACKGROUND

• 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.

  PMID: 20493797 BACKGROUND

• 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.

  PMID: 23623243 BACKGROUND

• 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.

  PMID: 26912285 BACKGROUND

• 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.

  PMID: 26934211 BACKGROUND

• 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.

  PMID: 27428534 BACKGROUND

• 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.

  PMID: 23306414 BACKGROUND

• 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.

  PMID: 27423026 BACKGROUND

• 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.

  PMID: 27004629 BACKGROUND

• 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.

  PMID: 26856315 BACKGROUND

• 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.

  PMID: 26296816 BACKGROUND

• 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.

  PMID: 20584755 BACKGROUND

• 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.

  PMID: 19447844 BACKGROUND

• 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.

  PMID: 26616188 BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Jay N Hertel, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel M Koldenhoven, MEd

CONTACT

434-924-6184; rmk7ye@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Clinician involved in rehabilitation will not know if participant has been enrolled in the gait biofeedback arm or the control (no biofeedback) arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: April 25, 2018
• Study Start: February 15, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 16, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)