Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05277181 |
| Other study ID # |
DSRS_01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
April 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Northumbria University |
| Contact |
Rachel Mason, MSc |
| Phone |
01912273343 |
| Email |
rachel2.mason[@]northumbria.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
