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

June 6, 2023 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: There are 3.1 million lateral ankle sprains in the United States per year, of which about 40% will develop persistent limitations leading to chronic ankle instability (CAI). People with CAI demonstrate altered walking gait mechanics including increased inversion (ie: the foot rolling outward) and a lateral shift in the location of the center of pressure (COP) under the foot. These changes cause people to walk on the outside of their foot and increases the risk for additional ankle sprains, abnormal cartilage strain, and early post traumatic ankle arthritis (PTOA). Evidence indicates that common treatments for CAI do not impact gait, leaving unresolved impairments that can lead to lifelong disability. Recently walking with novel sensory feedback techniques (visual, auditory, and visual stimuli) has immediately improved walking mechanics during laboratory training. However, real-world (RW) training is hypothesized to generate long-term changes by incorporating short, frequent training sessions over a variety of surfaces which are key training parameters to produce lasting change. Vibration feedback (VF) is currently the only tool capable of being deployed in the real world. Recent pilot data suggest that a single VF training session in the RW immediately improves ankle and COP position with changes lasting for up to 5 minutes. Despite these promising initial results, there remains a critical need to determine the impact of multiple real-word vibration feedback (RW-VF) sessions as an initial step to developing a protocol capable of long-term improvements.

Purpose: The purpose of this proposal is to examine the effectiveness of a new treatment approach by determining the extent to which 2-weeks of RW-VF restores gait biomechanics in those with CAI.

Design: Cohort Study Methods: Kinematic and kinetic data will be captured from 20 participants with CAI at two baseline training sessions within 48 hours of each other (B1 and B2) while the participant walks on an instrumented treadmill. These data will be used to calculate the minimal detectable change (MDC), which is the stability of the walking measures. Following B2, participants will be fitted with the VF tool and complete the first of six training sessions. During training sessions, participants will walk six standardized but unique 1-mile RW routes with VF within a two-week time period. The order of the routes will be determined by a random number generator. Three additional biomechanical walking assessments will be completed within 72 hours of (P-2), one week following the final training (F-1), and 4 weeks following the final training (F-4).

Data Analysis: The primary analysis will determine the impact of RW-VF on COP location during the stance phase of walking in people with CAI. COP location will be compared before and after treatment (B1:P-2) using paired t-tests to determine the immediate impact of RW-VF training. The change between B1 and P-2 will be compared to the MDC to rule out measurement error. Next, COP location between B1 and F-1, and B1 and F-4 will be calculated to determine the extent to which the COP change is retained and compared to the MDC to rule out measurement error. Finally, COP data from posttest and retention timepoints will be compared to a database of walking biomechanics data from healthy controls using independent t-tests to determine similarities between people with and without CAI following training. The secondary analysis will repeat the primary using ankle position in the frontal plane (inversion/ eversion) during stance.

Significance: These contributions have the potential to be significant because positive results will support a paradigm shift in treatments for people with CAI. Positive results will also lay the foundation for large scale clinical trials comparing the current standard of care to the standard of care with the addition of RW-VF training to optimize 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

CAI group:

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Criteria for precollected healthy control data Inclusion/ Exclusion Criteria

  • 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.)
  • not knowingly pregnant. Patient reported outcomes (ie: FAAM, IdFAI) were not collected as part of the previous study, therefore cannot be used as inclusion or exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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.
No Intervention: Healthy Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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).
The location of the 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. Subphases 2-10 of the data will be used for this secondary outcome.
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.
Time Frame: 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.
The location of the COP under the foot will be collected while CAI participants walk for 1-minute on an instrumented treadmill following 2-weeks of RWVF gait retraining (P-2). Previously, data were collected during 1-minute of walking on an instrumented treadmill from a healthy control cohort. Data from each stance phase of walking from both groups will be divided into 10 equal parts each representing 10% of stance and averaged across all steps. Subphases 1-10 of the data will be used for this secondary outcome to compare the COP location between groups.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Academy of Orthopaedic Physical Therapy

Investigators

  • Principal Investigator: Kimmery Migel, PT, DPT, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2022

Primary Completion (Actual)

April 6, 2023

Study Completion (Actual)

April 6, 2023

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

starting 9 months and continuing for 36 months following publication

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Ankle Instability

Clinical Trials on Real-world vibration feedback gait retraining

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe