NCT05277181

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 14, 2023

Status Verified

June 1, 2023

Enrollment Period

2.3 years

First QC Date

March 3, 2022

Last Update Submit

August 10, 2023

Conditions

Keywords

GaitWalkingRunningWearable Technology

Outcome Measures

Primary Outcomes (7)

  • Ground Contact Time

    (ms, mean ± standard deviation)

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

  • Tibial Acceleration

    (g, mean ± standard deviation)

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

  • Step Time

    (ms, mean ± standard deviation)

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

  • Step Length

    (cm, mean ± standard deviation)

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

  • Step Frequency

    (n, mean ± standard deviation)

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

  • Foot-strike Pattern

    (°, mean ± standard deviation)

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

  • Flight Time

    (ms, mean ± standard deviation)

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

Study Arms (1)

Runners

Recreational 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).

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, NE7 7XA, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 14, 2022

Study Start

November 1, 2021

Primary Completion

February 1, 2024

Study Completion

April 1, 2024

Last Updated

August 14, 2023

Record last verified: 2023-06

Locations