Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000431729
Ethics application status
Approved
Date submitted
4/03/2022
Date registered
16/03/2022
Date last updated
16/03/2022
Date data sharing statement initially provided
16/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of running gait retraining using wearable sensors in healthy runners
Scientific title
The effects of in-field running gait retraining using wearable sensors on lower limb kinematics, kinetics, and sub-maximal running economy in healthy runners
Secondary ID [1] 306554 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overuse running-related injuries 325449 0
Tibial bone stress injuries 325558 0
Medial tibial stress syndrome 325560 0
Patellofemoral pain 325561 0
Condition category
Condition code
Musculoskeletal 322829 322829 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Real-time feedback of landing impact forces will be the intervention in this study.

The intervention will consist of a running gait retraining intervention. Runners will be provided with small wearable sensors called inertial measurement units (IMU) to wear on each ankle. The intervention group will complete eight field-based runs lasting 15 to 30 minutes over a 3-week period while wearing these IMUs and will receive real-time audible feedback of their landing impacts. A GPS watch and heart rate monitor will be provided to participants for the duration for the study and running sessions will be pre-programmed on participants' watches.

The audible feedback will be provided through in-ear headphones connected to an iOS application that is paired to the IMUs. Runners will attempt to lower their landing impacts in response to the feedback provided. Participants will hear a high-pitched sound each time they exceed their pre-determined impact threshold (20% reduction from baseline values).

Field-based running sessions will commence at 15 mins in duration and increase by 3 mins each run until a maximum of 30 minutes is reached, which will be maintained for the remaining runs. Feedback duration will be continuous for Runs 1-4 and gradually removed the final four runs with total feedback duration for Run 5 = 21 mins, Runs 6 = 15 mins, Run 7 = 9 mins, and Run 8 = 3 mins.

Participants will be instructed to complete all runs outdoors in their local area on a firm surface (i.e., not grass or sand) with minimal gradient change, where possible. Running speed will be controlled using GPS watches with pre-defined "pacing zones" (± 5% of preferred speed determined at screening) to ensure stable running speeds across each run.

Adherence to this field-based running protocol will be monitored in a study diary that participants will be required to fill out following each field-based run and using the GPS watch and heart rate monitor that records running pace, gradient, and heart rate.
Intervention code [1] 322986 0
Prevention
Comparator / control treatment
The control group will complete identical sessions to the intervention group but will wear a single sham wearable sensor on one ankle that does not provide real-time feedback. They will be blinded to the existence of a gait retraining group and informed that researchers are interested in monitoring their running mechanics during field-based running.
Control group
Active

Outcomes
Primary outcome [1] 330612 0
Peak axial tibial acceleration (laboratory).
Measured for left and right limbs using two IMUs during the laboratory sessions.
Timepoint [1] 330612 0
Baseline.
Follow-up, approximately 3 weeks after the Baseline following the completion of the 8 field-based runs (Primary timepoint).
Retention, approximately 4 weeks after the Follow-up.
Primary outcome [2] 330613 0
Peak axial tibial acceleration (field).
Measured for left and right limbs using two IMUs during a 10-15 minute field-based run completed outdoors on a standardised oval.
Timepoint [2] 330613 0
Baseline.
Follow-up, approximately 3 weeks after the Baseline following the completion of the 8 field-based runs (Primary timepoint).
Retention, approximately 4 weeks after the Follow-up.
Secondary outcome [1] 406972 0
Sub-Maximal Running Economy.
Measured during sub-maximal treadmill running from the expired gases collected through a metabolic analysis system (COSMED).
Timepoint [1] 406972 0
Baseline (measured directly after the screening assessment).
Follow-up, approximately 3-4 weeks after Baseline following the completion of the 8 field-based runs.
Retention, approximately 4 weeks after Follow-up.
Secondary outcome [2] 407094 0
Self-Reported Difficulty during Running (Intervention group only).
Self-reported difficulty in maintaining the target impact feedback while running will be assessed following each field-based run using a 10 cm visual analogue scale, with terminal descriptors of 0 as “no difficulty” and 10 as “unable to perform”.
Timepoint [2] 407094 0
Self-reported directly after each of the 8 field-based runs where feedback is provided.
Secondary outcome [3] 407255 0
Vertical impact peak.
Measured using an 8 camera three-dimensional motion capture system (VICON, Oxford, UK) and force instrumented treadmill (AMTI Compact Tandem, US).
Timepoint [3] 407255 0
- Baseline.
- Follow-up, approximately 3 weeks after Baseline following the completion of the 8 field-based runs.
- Retention, approximately 4 weeks after Follow-up.
Secondary outcome [4] 407256 0
Vertical loading rates (instantaneous and average).
Measured using an 8 camera three-dimensional motion capture system (VICON, Oxford, UK) and force instrumented treadmill (AMTI Compact Tandem, US).
Timepoint [4] 407256 0
- Baseline.
- Follow-up, approximately 3 weeks after Baseline following the completion of the 8 field-based runs.
- Retention, approximately 4 weeks after Follow-up.
Secondary outcome [5] 407259 0
Peak axial tibial acceleration during the 8 field-based runs where feedback is provided (Intervention group only).
Peak axial tibial acceleration will be measured for left and right limbs using two IMUs during each of the 8 field based-runs.
Timepoint [5] 407259 0
Measured during each of the 8 field-based runs where feedback will be provided.
Secondary outcome [6] 407261 0
Lumbopelvic Pain during Running.
Self-reported lumbopelvic musculoskeletal pain during running will be assessed following each field-based run using participant training manuals. Pain will be assessed using a 10 cm visual analogue scale, with terminal descriptors of 0 as “no pain” and 10 as “severe pain.”
Timepoint [6] 407261 0
Self-reported by participants directly after completion of each of the 8 field-based runs.
Secondary outcome [7] 407262 0
Thigh Pain during Running.
Self-reported thigh musculoskeletal pain during running will be assessed following each field-based run using participant training manuals. Pain will be assessed using a 10 cm visual analogue scale, with terminal descriptors of 0 as “no pain” and 10 as “severe pain.”
Timepoint [7] 407262 0
Self-reported by participants directly after completion of each of the 8 field-based runs.
Secondary outcome [8] 407263 0
Knee Pain during Running.
Self-reported knee musculoskeletal pain during running will be assessed following each field-based run using participant training manuals. Pain will be assessed using a 10 cm visual analogue scale, with terminal descriptors of 0 as “no pain” and 10 as “severe pain.”
Timepoint [8] 407263 0
Self-reported by participants directly after completion of each of the 8 field-based runs.
Secondary outcome [9] 407264 0
Shin Pain during Running.
Self-reported shin musculoskeletal pain during running will be assessed following each field-based run using participant training manuals. Pain will be assessed using a 10 cm visual analogue scale, with terminal descriptors of 0 as “no pain” and 10 as “severe pain.”
Timepoint [9] 407264 0
Self-reported by participants directly after completion of each of the 8 field-based runs.
Secondary outcome [10] 407265 0
Calf Pain during Running.
Self-reported calf musculoskeletal pain during running will be assessed following each field-based run using participant training manuals. Pain will be assessed using a 10 cm visual analogue scale, with terminal descriptors of 0 as “no pain” and 10 as “severe pain.”
Timepoint [10] 407265 0
Self-reported by participants directly after completion of each of the 8 field-based runs.
Secondary outcome [11] 407266 0
Ankle Pain during Running.
Self-reported ankle musculoskeletal pain during running will be assessed following each field-based run using participant training manuals. Pain will be assessed using a 10 cm visual analogue scale, with terminal descriptors of 0 as “no pain” and 10 as “severe pain.”
Timepoint [11] 407266 0
Self-reported by participants directly after completion of each of the 8 field-based runs.
Secondary outcome [12] 407267 0
Foot Pain during Running.
Self-reported foot musculoskeletal pain during running will be assessed following each field-based run using participant training manuals. Pain will be assessed using a 10 cm visual analogue scale, with terminal descriptors of 0 as “no pain” and 10 as “severe pain.”
Timepoint [12] 407267 0
Self-reported by participants directly after completion of each of the 8 field-based runs.
Secondary outcome [13] 407308 0
Step rate.
Measured using an 8 camera three-dimensional motion capture system (VICON, Oxford, UK) and force instrumented treadmill (AMTI Compact Tandem, US).
Timepoint [13] 407308 0
- Baseline.
- Follow-up, approximately 3 weeks after Baseline following the completion of the 8 field-based runs.
- Retention, approximately 4 weeks after Follow-up.
Secondary outcome [14] 407309 0
Stride length.
Measured using an 8 camera three-dimensional motion capture system (VICON, Oxford, UK) and force instrumented treadmill (AMTI Compact Tandem, US).
Timepoint [14] 407309 0
- Baseline.
- Follow-up, approximately 3 weeks after Baseline following the completion of the 8 field-based runs.
- Retention, approximately 4 weeks after Follow-up.
Secondary outcome [15] 407310 0
Joint angle curves at the ankle across the gait cycle.
Measured using an 8 camera three-dimensional motion capture system (VICON, Oxford, UK)
Timepoint [15] 407310 0
- Baseline.
- Follow-up, approximately 3 weeks after Baseline following the completion of the 8 field-based runs.
- Retention, approximately 4 weeks after Follow-up.
Secondary outcome [16] 407311 0
Joint angle curves at the knee across the gait cycle.
Measured using an 8 camera three-dimensional motion capture system (VICON, Oxford, UK)
Timepoint [16] 407311 0
- Baseline.
- Follow-up, approximately 3 weeks after Baseline following the completion of the 8 field-based runs.
- Retention, approximately 4 weeks after Follow-up.
Secondary outcome [17] 407312 0
Joint angle curves at the hip across the gait cycle.
Measured using an 8 camera three-dimensional motion capture system (VICON, Oxford, UK)
Timepoint [17] 407312 0
- Baseline.
- Follow-up, approximately 3 weeks after Baseline following the completion of the 8 field-based runs.
- Retention, approximately 4 weeks after Follow-up.

Eligibility
Key inclusion criteria
Run at least 10 km per week on average over the previous three months.
Own or have access to an iOS 12+ smartphone (necessary for recording field-based outcomes through an iOS application).
Fluent in English.
Identified as a high impact runner (defined as having a peak tibial acceleration >9 g while running at 3.7 m/s during a screening assessment)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Recent running-related lower limb injuries (within the past six weeks).
2) History of lower limb surgery or any neurological, inflammatory, or rheumatoid disease that may affect running gait.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent researcher (not involved in data collection) will use a random number generator and blocked randomisation to ensure equal participants per group (n = 15).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be electronically stored in a password protected folder not accessible to the primary researcher. Randomisation will be stratified by sex to ensure equal representation and reduce the likelihood of influence of sex-specific variables.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The control group will be blinded to the existence of a gait retraining group and informed researchers are interested in monitoring their running mechanics during field-based running. Due to the nature of the intervention, it will be impossible to blind the intervention group.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Baseline demographics will be compared using t-tests and Chi-square tests. Per protocol analyses will be performed to assess the effect of the gait retraining group at the end of the eight field-based runs. Participants unable to complete follow-up or retention assessments due to injury will not be included in the per-protocol analysis. All dropouts and reasons for underlying dropouts will be reported. Vertical loading rates, running kinematics, running kinetics, and sub-maximal running economy will be compared between groups using a linear mixed-effects model with independent variables group, time and group*time interactions. Participant ID will be a random effect. Post-hoc comparisons will be made using pairwise t-tests with a Holm-Bonferroni adjustment for multiple comparisons. All statistical analyses will be performed in Jamovi. Statistical significance will be assumed for p <0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/03/2022
Actual
Date of last participant enrolment
Anticipated
24/10/2022
Actual
Date of last data collection
Anticipated
23/12/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310808 0
University
Name [1] 310808 0
Macquarie University
Country [1] 310808 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University, North Ryde, NSW 2109.
Country
Australia
Secondary sponsor category [1] 312169 0
None
Name [1] 312169 0
Address [1] 312169 0
Country [1] 312169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310376 0
Macquarie University Human Research Ethics Committee.
Ethics committee address [1] 310376 0
Ethics committee country [1] 310376 0
Australia
Date submitted for ethics approval [1] 310376 0
15/11/2021
Approval date [1] 310376 0
25/11/2021
Ethics approval number [1] 310376 0
520211086135306

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117434 0
Mr Eoin Doyle
Address 117434 0
Macquarie University, North Ryde, NSW 2109.
Country 117434 0
Australia
Phone 117434 0
+61298506613
Fax 117434 0
Email 117434 0
[email protected]
Contact person for public queries
Name 117435 0
Eoin Doyle
Address 117435 0
Macquarie University, North Ryde, NSW 2109.
Country 117435 0
Australia
Phone 117435 0
+61298506613
Fax 117435 0
Email 117435 0
[email protected]
Contact person for scientific queries
Name 117436 0
Eoin Doyle
Address 117436 0
Macquarie University, North Ryde, NSW 2109.
Country 117436 0
Australia
Phone 117436 0
+61298506613
Fax 117436 0
Email 117436 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified laboratory data collection sets and associated metadata.
When will data be available (start and end dates)?
Start date: Project completion.
End date: Indefinite.
Available to whom?
Available on a case-by-case basis upon reasonable request and subject to the intended secondary analysis receiving human research ethics committee approval.
Available for what types of analyses?
Scientific research only.
How or where can data be obtained?
Macquarie University Research Data Repository.
https://figshare.mq.edu.au/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15239Ethical approval  [email protected] 383594-(Uploaded-28-02-2022-14-56-03)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.