Wearable Technology as an Objective Tool for Measuring Running Gait

Sponsor
Northumbria University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05277181
Collaborator
DANU Sports Ltd (Other)
40
1
22
1.8

Study Details

Study Description

Brief Summary

The investigators aim to use a repeated measures observational study utilising a battery of multimodal assessment tools (3D motion capture, video analysis, wearable technology) in order to validate the DANU Sports Socks. The investigators aim to recruit 40 recreational runners (male and female) from the North East of England. The multimodal battery assessment used in this study will compare metrics between gold-standard traditional assessment methods and more novel wearable technology methods.

Following assessment of the validity and reliability of the DANU Sports Socks, the investigators will use the multi-modal sensor to quantify changes in running gait that may occur with injury, fatigue or performance level will permit quantification of running demands in a runner's natural environment, thereby providing insight into injury mechanisms and objective explanations for performance outcomes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Background:

    Objective measurement of running gait is an important clinical tool for injury assessment and provides metrics that can be used to enhance performance. Running gait assessment has traditionally been performed using subjective observation or expensive laboratory-based objective technologies, such as 3D motion capture or force plates. However, recent developments in wearable technology allow for continuous monitoring and analysis of running mechanics in any environment, but technologies used for assessment must be valid and reliable. The objective of this study is to investigate the validity, reliability and subsequently the applied use of a commercial wearable technology (DANU Sports System) for running gait assessment. Following assessment of the validity and reliability of the DANU Sports Socks, the investigators use the multi-modal sensor to quantify changes in running gait that may occur with injury, fatigue or performance level will permit quantification of running demands in a runner's natural environment, thereby providing insight into injury mechanisms and objective explanations for performance outcomes.

    Methods:

    With institutional ethics approval (Ref: 33358), 40 healthy adult athletes (aged 18-70 years) will wear a commercial wearable technology (DANU Sports System) and be tracked with gold-standard laboratory reference systems (OptoGait, 3D motion capture and force plates) during running. Participants will repeat testing in two sessions, one week apart in the biomechanics laboratory at Northumbria University. Testing will involve treadmill running (5-minute trials at 3 controlled speeds) and intermittent over-ground running (10 trials per foot at controlled speeds), completed in a standardised shoe. For the applied aspect of the study, researchers will ask participants to complete a battery of tests, as well as their normal training regimes in the DANU Sports System. Running gait outcomes will include ground reaction forces, ground contact time, flight time, cadence, stride length, stride time and stride velocity. Wearable system validity and reliability will be examined using intra-class correlation coefficients and Bland-Altman plots to compare to laboratory reference standards.

    For the applied aspect of the study, 40 healthy adult athletes (aged 18-70 years) will wear a commercial wearable technology (DANU Sports System). Participants from varying sports and of different performance levels will be recruited. Researchers will ask participants to complete a battery of tests (balance, jumps, walking and running), as well as their normal training/running regimes in the DANU Sports System.

    Conclusions:

    This study outlines a protocol for a multimodal approach for the use of wearable technology to augment traditional approaches to running gait analysis, which may better inform sports medicine and sports performance practice. Findings may shed light on the new ways of working with wearable technology for running gait analysis. Multimodal approaches may enhance understanding of running biomechanics and provide scalable, more objective assessment. Overall, wearable technology is rapidly becoming a feasible means to quantify running biomechanics in a more ecologically valid manner, with applications in sports medicine and sports performance. Regardless, practitioners should ensure that the use of wearable technology is evidence-based and fully investigate the accuracy, reliability, and value of any wearable device prior to incorporating them into practice. If accurate and reliable, the DANU Sports System would be a comprehensive tool for sports and clinical practitioners as it combines accelerometry and pressure sensors in the form of a sock.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Wearable Technology as an Objective Tool for Measuring Running Gait
    Actual Study Start Date :
    Nov 1, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Recreational runners

    Recreational runners will be recruited and assessed over one season (June 2021 to January 2023). Participants will be asked to complete a battery of sub-maximal exercise tests. Exercises will include, balance, jump, walking and running tasks. Participants will be stratified according to gender (males n≈20, and females n≈20). Participants may also be further stratified based on injury status (i.e. injury history and location) and performance level (i.e. 5km personal best time).

    Runners

    Recreational runners will be recruited and assessed over one season (June 2021 to January 2023). Participants will be asked to complete a battery of sub-maximal exercise tests. Exercises will include, balance, jump, walking and running tasks. Participants will be stratified according to gender (males n≈20, and females n≈20). Participants may also be further stratified based on injury status (i.e. injury history and location) and performance level (i.e. 5km personal best time).

    Sports Participants

    Recreational, amateur, trained and elite sports people will be recruited and assessed over one season (June 2021 to January 2023). Participants will be asked to complete a battery of sub-maximal exercise tests. Exercises will include, balance, jump, walking and running tasks. Participants will be stratified according to gender (males n≈20, and females n≈20). Participants may also be further stratified based on injury status (i.e. injury history and location) and performance level (i.e. 5km personal best time, sports performance level).

    Outcome Measures

    Primary Outcome Measures

    1. Ground Contact Time [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (ms, mean ± standard deviation)

    2. Stance Time [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (ms, mean ± standard deviation)

    3. Swing Time [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (ms, mean ± standard deviation)

    4. Stride Time [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (ms, mean ± standard deviation)

    5. Stride Length [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (cm, mean ± standard deviation)

    6. Stride Velocity [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (cm-1, mean ± standard deviation)

    7. Step Frequency [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (n, mean ± standard deviation)

    8. Foot-strike Pattern [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (°, mean ± standard deviation)

    9. Flight Time [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (ms, mean ± standard deviation)

    Secondary Outcome Measures

    1. Tibial Acceleration [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (g, mean ± standard deviation)

    2. Peak Pressure [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (kPa, mean ± standard deviation)

    3. Contact Area [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

    4. Pressure-Time Integral [Participants will be asked to attend two laboratory sessions 7 - 14 days apart.]

      (kPa/s, mean ± standard deviation)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Fluent in the English language

    • Aged 18 - 70 years

    • Take part in running of some form (i.e. on it's own or as part of a sport)

    Exclusion Criteria:
    • History of physical, cognitive impairment that would significantly impact mobility and or ability to follow instructions/ tasks

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northumbria University Newcastle upon Tyne United Kingdom NE7 7XA

    Sponsors and Collaborators

    • Northumbria University
    • DANU Sports Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Northumbria University
    ClinicalTrials.gov Identifier:
    NCT05277181
    Other Study ID Numbers:
    • DSRS_01
    First Posted:
    Mar 14, 2022
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Northumbria University

    Study Results

    No Results Posted as of Apr 12, 2022