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

Ankle Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03507803
• Other study ID #: 20446
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2018
• Est. completion date: March 2020

Study information

• Verified date: May 2018
• Source: University of Virginia
• Contact: Rachel M Koldenhoven, MEd
• Phone: 434-924-6184
• Email: rmk7ye[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• >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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (17)

Bonnel F, Toullec E, Mabit C, Tourné 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Feger MA, Hertel J. Surface electromyography and plantar pressure changes with novel gait training device in participants with chronic ankle instability. Clin Biomech (Bristol, Avon). 2016 Aug;37:117-124. doi: 10.1016/j.clinbiomech.2016.07.002. Epub 2016 Jul 7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline Ankle Sagittal Plane Angle During Gait	Ankle sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.	Baseline, 4 weeks
Secondary	Change from Baseline Ankle Transverse Plane Angle During Gait	Ankle transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.	Baseline, 4 weeks
Secondary	Change from Baseline Hip Frontal Plane Angle During Gait	Hip frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.	Baseline, 4 weeks
Secondary	Change from Baseline Hip Sagittal Plane Angle During Gait	Hip sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.	Baseline, 4 weeks
Secondary	Change from Baseline Hip Transverse Plane Angle During Gait	Hip transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.	Baseline, 4 weeks
Secondary	Change from Baseline Knee Frontal Plane Angle During Gait	Knee frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.	Baseline, 4 weeks
Secondary	Change from Baseline Knee Sagittal Plane Angle During Gait	Knee sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.	Baseline, 4 weeks
Secondary	Change from Baseline Knee Transverse Plane Angle During Gait	Knee transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.	Baseline, 4 weeks
Secondary	Change from Baseline Range of motion	Ankle range of motion will be assessed using a plastic goniometer	Baseline, 4 weeks
Secondary	Change from Baseline Balance	Single limb balance with eyes open and eye closed conditions will be assessed using a Tekscan pressure mat	Baseline, 4 weeks
Secondary	Change from Baseline Strength	Ankle and hip strength will be assessed using a handheld dynamometer in N	Baseline, 4 weeks
Secondary	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.	Baseline, 4 weeks
Secondary	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.	Baseline, 4 weeks
Secondary	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.	Baseline, 4 weeks
Secondary	Change from Baseline International Physical Activity Questionnaire	The International Physical Activity Questionnaire total score will be assessed. Higher scores represent increased physical activity.	Baseline, 4 weeks
Secondary	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.	Baseline, 4 weeks
Secondary	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.	Baseline, 4 weeks
Secondary	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.	4 weeks
Secondary	Change from Baseline Physical Activity	Fitbit Charge HR monitors will be worn by all participants for 4 weeks. Average daily steps will be analyzed.	Baseline, 4 weeks