The Impact of Real-World Vibration Feedback Gait Retraining on Gait Biomechanics in People With Chronic Ankle Instability

NCT05327244 | Completed

• 1 other identifier: 22-0399
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

People with chronic ankle instability (CAI) demonstrate altered gait or walking mechanics which cause people to walk on the outside of their foot and increases the risk of additional ankle sprains, abnormal cartilage strain, and early joint degeneration. Evidence indicates that common treatments for CAI do not impact gait, leaving unresolved impairments that can lead to lifelong disability. Recent lab-based gait retraining with visual and auditory feedback has immediately improved walking mechanics. However, real-world training is hypothesized to generate long-term changes by incorporating short, frequent training sessions over a variety of surfaces. These are key training parameters to produce lasting change. Pilot data using real-world vibration feedback (RW-VF) suggest that a single session immediately improves walking mechanics with changes lasting for up to 5 minutes. Despite promising initial results, there remains a critical need to determine the impact of multiple RW-VF sessions as an initial step to developing a protocol capable of long-term improvements. The purpose of this proposal is to determine the extent to which 2-weeks of RW-VF restores gait biomechanics in those with CAI. Twenty people with CAI will be enrolled and complete a two-week gait retraining protocol with vibration feedback. Walking mechanics before, immediately after, and 1 week and 4 weeks following the training will be compared. These contributions can be significant as positive results will support a paradigm shift in treatments for people with CAI and lay the foundation for large scale clinical trials aimed at optimizing long term gains. The outcomes of future research have the potential to advance evidenced based rehabilitation interventions not only for people with CAI but also for people who have sustained a variety of musculoskeletal injuries as there is strong evidence that other lower extremity pathologies cause lifelong limitations, including changes in walking mechanics which lead to degenerative changes to other joints.

Conditions

Chronic Ankle Instability

Keywords

ankle; walking; biofeedback

Outcome Measures

Primary Outcomes (1)

• Immediate and retained changes in the center of pressure location under the foot at initial contact within the chronic ankle instability group in response to 2-weeks of RWVF gait retraining.

  The location of the center of pressure (COP) under the foot will be collected while participants walk for 1-minute on an instrumented treadmill at each assessment in this repeated measures study (baseline, P-2, F-1, F-4). Data from each stance phase of walking will be divided into 10 equal parts each representing 10% of stance and averaged across all steps. Subphase 1 of the data will be used for the primary outcome as it represents initial contact of gait.

  COP location during walking will be measured at baseline, within 72 hours of completing the intervention (P-2), 1 week after the intervention (F-1), 1 month after the intervention (F-4).

Secondary Outcomes (2)

• Immediate and retained changes in the center of pressure location under the foot from 20% to 100% of the walking stance phase within the chronic ankle instability group in response to 2-weeks of RWVF gait retraining.

  COP location during walking will be measured at baseline, within 72 hours of completing the intervention (P-2), 1 week after the intervention (F-1), 1 month after the intervention (F-4).

• Differences between the COP location in people with CAI following 2-weeks of RWVF gait retraining and the COP location in healthy controls.

  The COP location during walking will be measured following 2-weeks of training (P-2) in the CAI cohort and compared to pre-collected, de-identified healthy control data from a single session.

Study Arms (2)

Intervention

EXPERIMENTAL

All CAI participants will complete the same intervention and will walk 6, 1-mile paths in the real wold (ie: around campus) with vibration feedback within 2 weeks of baseline assessment. A study team member will accompany each participant during each training.

Other: Real-world vibration feedback gait retraining

Healthy Control

NO INTERVENTION

Posttest data from CAI participants will be compared to de-identified healthy control data collected as part of a previous study. Healthy control participants completed a single research session to collect walking biomechanics using the same methods as this project. They received no further follow up or intervention and the inclusion/ exclusion criteria for this group match those of the chronic ankle instability cohort.

Interventions

Real-world vibration feedback gait retraining OTHER

Participants will walk with a vibration feedback tool attached to their shoelaces. A small force sensing resistor is taped to the foot bed of the shoe under the lateral foot and a vibration motor is placed over the outside of the ankle with a strap. When a participant walks on the outside of their foot, they will exceed the pressure threshold and activate the feedback which signifies an incorrect foot placement. The feedback is intended to prompt a correct foot placement on the subsequent step. Participants will use the same feedback tool for 6 real world training sessions.

Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• between the ages of 18 - 35 years
• will have a history of at least 1 significant lateral ankle sprain which occurred at least 12 months prior to enrollment defines as a sprain which caused at least 1 day of interrupted physical activity
• have a history of recurrent sprains and/or episodes of "giving way"
• have a sense of ankle instability measured by a score of ≥ 11 on the Identification of Functional Ankle Instability (IdFAI)
• have self-reported functional limitations measured by a score of \< 90% of the Foot and Ankle Ability Measure (FAAM)-Activities of Daily Living subscale and \< 80% on the FAAM-Sport subscale.

You may not qualify if:

• evidence of bilateral CAI using the criteria above
• history of previous surgery in either lower extremity
• history of a fracture requiring realignment in either lower extremity
• an acute (\< 12 weeks from enrollment) injury to either lower extremity
• any condition known to affect gait such as peripheral neuropathy, diabetes, neurological disorders, or neurodegenerative diseases
• knowingly pregnant.
• between the ages of 18-35 years
• no previous history of lower extremity surgery
• no lower extremity injury history in the past 6 months
• no history of neurological disorders (i.e.: stroke, cerebral palsy, multiple sclerosis, etc.)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Academy of Orthopaedic Physical Therapy: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (12)

• 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

• Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.

  PMID: 24377963 BACKGROUND

• Wikstrom EA, Song K, Tennant JN, Dederer KM, Paranjape C, Pietrosimone B. T1rho MRI of the talar articular cartilage is increased in those with chronic ankle instability. Osteoarthritis Cartilage. 2019 Apr;27(4):646-649. doi: 10.1016/j.joca.2018.12.019. Epub 2019 Jan 8.

  PMID: 30634032 BACKGROUND

• Gribble PA, Bleakley CM, Caulfield BM, Docherty CL, Fourchet F, Fong DT, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, Verhagen EA, Vicenzino BT, Wikstrom EA, Delahunt E. Evidence review for the 2016 International Ankle Consortium consensus statement on the prevalence, impact and long-term consequences of lateral ankle sprains. Br J Sports Med. 2016 Dec;50(24):1496-1505. doi: 10.1136/bjsports-2016-096189. Epub 2016 Jun 3.

  PMID: 27259753 BACKGROUND

• Torp DM, Thomas AC, Donovan L. External feedback during walking improves measures of plantar pressure in individuals with chronic ankle instability. Gait Posture. 2019 Jan;67:236-241. doi: 10.1016/j.gaitpost.2018.10.023. Epub 2018 Oct 21.

  PMID: 30380508 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

• 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

• Yen SC, Corkery MB, Donohoe A, Grogan M, Wu YN. Feedback and Feedforward Control During Walking in Individuals With Chronic Ankle Instability. J Orthop Sports Phys Ther. 2016 Sep;46(9):775-83. doi: 10.2519/jospt.2016.6403. Epub 2016 Aug 5.

  PMID: 27494057 BACKGROUND

• Feger MA, Hart JM, Saliba S, Abel MF, Hertel J. Gait training for chronic ankle instability improves neuromechanics during walking. J Orthop Res. 2018 Jan;36(1):515-524. doi: 10.1002/jor.23639. Epub 2017 Aug 11.

  PMID: 28653780 BACKGROUND

• Erhart-Hledik JC, Asay JL, Clancy C, Chu CR, Andriacchi TP. Effects of active feedback gait retraining to produce a medial weight transfer at the foot in subjects with symptomatic medial knee osteoarthritis. J Orthop Res. 2017 Oct;35(10):2251-2259. doi: 10.1002/jor.23527. Epub 2017 Feb 9.

  PMID: 28120496 BACKGROUND

• Migel KG, Wikstrom EA. The effect of laboratory and real world gait training with vibration feedback on center of pressure during gait in people with chronic ankle instability. Gait Posture. 2021 Mar;85:238-243. doi: 10.1016/j.gaitpost.2021.02.011. Epub 2021 Feb 17.

  PMID: 33621942 BACKGROUND

• Migel KG, Wikstrom EA. Immediate effects of vibration biofeedback on ankle kinematics in people with chronic ankle instability. Clin Biomech (Bristol). 2021 Dec;90:105495. doi: 10.1016/j.clinbiomech.2021.105495. Epub 2021 Sep 25.

  PMID: 34601325 BACKGROUND

Study Officials

• Kimmery Migel, PT, DPT

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All CAI participants will be assigned to the intervention arm and will all receive the same treatment (6 sessions of RWVF gait retraining in 2-weeks). Posttest data from CAI participants in arm 1 will be compared to data from pre-collected de-identified healthy control data.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 14, 2022
• Study Start: June 9, 2022
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: starting 9 months and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)