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WalkingNCT05277181

Wearable Technology as an Objective Tool for Measuring Running Gait

An observational study of Walking and Running, run by Northumbria University at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators aim to use a repeated measures observational study utilising a battery of multimodal assessment tools (e.g., 3D motion capture, 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Walking, Running, Gait
How many people
80 participants
Where
1 siteUnited Kingdom
Study dates
1 Nov 2021to Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Within the laboratory testing 40 individuals will be recruited, specifically 20 with and 20 without a history of previous lower limb injury (but fully recovered at time of assessment and able to run safely, in line with inclusion / exclusion criteria). Within the real-world environment testing 40 individuals, specifically novice/amateur (n=20) and expert/sub-elite (n=20) running performance level, based on their 5km running time (i.e., age graded performance % (35)). Participants will be stratified according to sex, dependent on the participants obtained investigators may also stratify the sample based on injury status, sports and performance level.

Who may be able to join

  • Aged 18 - 70 years. English as a first language or fluency. Able to run 5km without stopping. Take part in running of some form at least twice per week (e.g., 5km run).

Who cannot join

  • Medical history of disability that affects running gait safety or ability to follow instructions/tasks.
  • Known illness or disease that would prevent their participation in strenuous physical activities (e.g., cardio-respiratory conditions or acute COVID-19).
  • If the participant is unable to comply with the testing protocol, they will not be recruited.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • Northumbria University

    Newcastle upon Tyne, NE7 7XA

    Samuel Stuart, PhD, 0191 227 3343, sam.stuart@northumbria.ac.uk

    Sam Stuart, PhD

    Recruiting

Other trials in United Kingdom

About this study

The investigators aim to use a repeated measures observational study utilising a battery of multimodal assessment tools (e.g., 3D motion capture, 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.

Read the 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:

Laboratory Testing: With institutional ethics approval (Ref: 33358), laboratory testing will be conducted at the biomechanics laboratory Northumbria University, Newcastle upon Tyne, United Kingdom. Within the controlled laboratory environment, we will conduct a concurrent data collection with the multimodal, commercial, or research-grade wearables to determine their validation and reliability for running gait analysis compared to laboratory reference standards (3D motion capture and force plates).

Participants: Within the laboratory testing 40 individuals will be recruited. Laboratory reference set-up: A 3D motion capture and force plate system will be used as the 'gold-standard' reference measures.

Running procedures: All participants will run overground and, on a treadmill (Spirit fitness XT485). Participants will be provided with a standardised, neutral cushioning running shoe (Saucony Guide Runner) to wear during testing. For the overground segment, participants will run at a comfortable self-selected speed overground for 10m intermittently, where they will be asked to foot-strike two staggered force plates in the middle of the run (~5m point). Practice trials will be performed prior to data collection to allow participants to adjust their start position to strike the force plates correctly. A total of five successful recordings for each of the left and right leg will be captured. For the treadmill segment, participants will be asked to run at five speeds, four of these speeds will be standardised (i.e., 8, 10, 12 and 14 km/hr) and one speed will be their self-selected speed. Self-selected speed will be determined by the participant's 5km personal best. The order of speed will be consistent across participants, starting at the slowest speed and progressing to the fastest, which is to ensure the safety of participants.

Wearable device validity and reliability will be examined using intra-class correlation coefficients and Bland-Altman plots to compare to laboratory reference standards.

Real-world environment testing: Data from the novel multimodal, commercial, and research-grade wearables will be collected within real-world environments to test the clinical / performance validity of the wearables (i.e., can they differentiate or provide meaningful data on relevant populations).

Participants: Within the real-world environment testing 40 individuals, specifically novice/amateur (n=20) and expert/sub-elite (n=20) running performance level, based on their 5km running time (i.e., age graded performance %).

Wearable location: Each participant will be equipped with the DANU Sports System (socks on both feet), two Axivity AX6 sensors attached to the shoelaces and two DorsaVi ViMove2 sensors on the tibia.

Running procedures: All participants, regardless of performance level, will be asked to complete a 5km run on a standardised route in North-East England. The course will be run on a mixture of trail paths and concrete paths, with 174ft elevation gain throughout. Information about conditions (e.g., environment and shoes) and objective load data (e.g., time and pace) will be collected. Participants will wear their own running shoes.

Running gait outcomes will include ground reaction forces, ground contact time, flight time, cadence, stride length, stride time and stride velocity.

Conclusions:

This exploratory observational study will assist with understanding the role that various grades of wearable devices (research-grade, commercial, novel multimodal) can have when assessing running gait inside and outside of the laboratory environment. In addition, it will provide evidence on the relationships between demographic factors, injury status, and performance level on objectively measured running gait outcomes. The outcomes of this study 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.

Keywords
Gait, Walking, Running, Wearable Technology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05277181
Study groupRoleWhat they receive
RunnersRecreational runners will be recruited and assessed over one season (June 2021 to January 2024). Participants will be asked to complete a battery of sub-maximal walking and running trials. 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ground Contact Time

    (ms, mean ± standard deviation)

    Measured: Participants will be asked to attend two laboratory sessions 7 - 14 days apart.

  2. Tibial Acceleration

    (g, mean ± standard deviation)

    Measured: Participants will be asked to attend two laboratory sessions 7 - 14 days apart.

  3. Step Time

    (ms, mean ± standard deviation)

    Measured: Participants will be asked to attend two laboratory sessions 7 - 14 days apart.

  4. Step Length

    (cm, mean ± standard deviation)

    Measured: Participants will be asked to attend two laboratory sessions 7 - 14 days apart.

  5. Step Frequency

    (n, mean ± standard deviation)

    Measured: Participants will be asked to attend two laboratory sessions 7 - 14 days apart.

  6. Foot-strike Pattern

    (°, mean ± standard deviation)

    Measured: Participants will be asked to attend two laboratory sessions 7 - 14 days apart.

  7. Flight Time

    (ms, mean ± standard deviation)

    Measured: Participants will be asked to attend two laboratory sessions 7 - 14 days apart.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2022
  2. Study start1 Nov 2021
  3. Primary completionFeb 2024 (estimated)
  4. Study completionApr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05277181
Sponsor's protocol ID
DSRS_01
Status last verified
Jun 2023
First submitted
3 Mar 2022
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mason R, Godfrey A, Barry G, Stuart S. Wearables for running gait analysis: A study protocol. PLoS One. 2023 Sep 11;18(9):e0291289. doi: 10.1371/journal.pone.0291289. eCollection 2023.

    PubMed 37695752

Questions about this trial

What is this clinical trial studying?

An observational study of Walking and Running, run by Northumbria University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rachel Mason, MSc (01912273343, rachel2.mason@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ground Contact Time (time frame: Participants will be asked to attend two laboratory sessions 7 - 14 days apart.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05277181, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.

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