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Trial registered on ANZCTR


Registration number
ACTRN12621001525875
Ethics application status
Approved
Date submitted
14/09/2021
Date registered
9/11/2021
Date last updated
10/05/2023
Date data sharing statement initially provided
9/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility trial of flat, flexible school shoes for management of adolescent patellofemoral pain
Scientific title
A feasibility trial of flat, flexible school shoes for management of adolescent patellofemoral pain
Secondary ID [1] 305304 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral pain 323621 0
Condition category
Condition code
Musculoskeletal 321155 321155 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 321158 321158 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Flat, flexible shoes:
Participants will receive a commercially available flat flexible shoe that conforms to school uniform guidelines (e.g. Vivobarefoot Primus Lite or RA II). The shoe will be lightweight, have minimal stability features, a low stack height and no heel-toe offset. Participants will attend a 30 minute baseline session with research staff to have the shoes individually fitted. Participants will wear this shoe as per school requirements throughout the 12-week intervention period. A graduated exposure to the shoe based on days per week will be used. Participants will be instructed to wear the shoes for 2 school days in the first week, 3 school days in weeks 2-3, and every day that school shoes are worn in weeks 4-12 (except for sports uniform day). Written instructions for this exposure and adaption, specific to this study, will be provided. Participants will be asked to record their daily hours of wear in a weekly logbook.
Intervention code [1] 321715 0
Treatment: Devices
Comparator / control treatment
Regular school shoe:
Participants will be provided with a new pair of standard school shoes (e.g. Clarks Daytona) and instructed to wear them at all times they would usually wear their school shoe. Participants will be asked to record their daily hours of wear in a weekly logbook.
Control group
Active

Outcomes
Primary outcome [1] 328950 0
Feasibility is a composite outcome, and will be assessed by evaluating:
(i) willingness of participants to enrol (from recruitment database);
(ii) number of eligible participants (from recruitment database);
(iii) recruitment rate (from recruitment database);
(iv) adherence with allocated intervention and log book completion (from participant logbooks);
(v) adverse effects (from participant logbooks); and
(vi) drop-out rate (from trial database).
Participants will be asked to complete their log-books (electronic or paper), assisted by their parent/guardian as required and checked for completion. Participants will record their footwear worn and any adverse effects. Possible adverse events include blisters, calf or Achilles tendon pain, or heel or arch pain.
Timepoint [1] 328950 0
Assessed at completion of data collection
Secondary outcome [1] 400917 0
Worst pain severity will be measured using a 100mm visual analogue scales (where 0mm = no pain and 100mm = worst pain imaginable). Participants will be asked to rate their worst pain in the preceding week.
Timepoint [1] 400917 0
Baseline and 6 and 12 weeks post-intervention commencement.
Secondary outcome [2] 400918 0
Global rating of change (GROC) will be measured on an 7-point Likert scale (‘completely recovered’, ‘strongly recovered’, ‘slightly recovered’, ‘same’, ‘slightly worse’, ‘much worse’ and ‘worse than ever’).
Timepoint [2] 400918 0
Baseline and 6 and 12 weeks post-intervention commencement.
Secondary outcome [3] 400919 0
Participants will complete the Knee Injury and Osteoarthritis Outcome Score (KOOS) patellofemoral subscale (KOOS-PF).
Timepoint [3] 400919 0
Baseline and 6 and 12 weeks post-intervention commencement.
Secondary outcome [4] 400920 0
Participants will complete the Child Version of the Knee injury and Osteoarthritis Outcome Score (KOOS-Child).
Timepoint [4] 400920 0
Baseline and 6 and 12 weeks post-intervention commencement.
Secondary outcome [5] 400921 0
The Anterior Knee Pain Scale will be used to measure symptoms and function.
Timepoint [5] 400921 0
Baseline and 6 and 12 weeks post-intervention commencement.
Secondary outcome [6] 400922 0
Participants will complete the Youth quality of life- short form (YQOL-SF) as a measure of their quality of life
Timepoint [6] 400922 0
Baseline and 6 and 12 weeks post-intervention commencement.
Secondary outcome [7] 400923 0
Use of co-interventions: Participants will be asked to keep a daily record of any other interventions utilised throughout the study (outside of their allocated intervention) (e.g. pain medication, physiotherapy).
Timepoint [7] 400923 0
Baseline and 6 and 12 weeks post-intervention commencement.
Secondary outcome [8] 400924 0
Lower limb kinematics and kinetics: Participant's lower limb kinematics and kinetics will be assessed during walking and running using an 8 camera motion analysis and instrumented treadmill.
Timepoint [8] 400924 0
Baseline and 12 weeks post intervention commencement.
Secondary outcome [9] 402557 0
Pain severity will be measured using a 100mm visual analogue scales (where 0mm = no pain and 100mm = worst pain imaginable). Participants will be asked to rate their average pain in the preceding week.
Timepoint [9] 402557 0
Baseline and 6 and 12 weeks post intervention commencement.

Eligibility
Key inclusion criteria
(i) Aged 12-18 years; (ii) anterior knee pain of non-traumatic origin for at least 6 weeks duration; (iii) pain that is rated at least 3 on an 11-point numerical rating scale (0=no pain, 10=maximal pain); and (iv) knee pain aggravated by activities that load the patellofemoral joint (e.g. squatting, stair climbing)
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Concomitant pain at sites other than the anterior knee; (ii) history of knee, hip or spine surgery, or other suspected knee joint pathology (e.g. Osgood Schlatter’s Disease); (iii) planned lower limb surgery (e.g. arthroscopy); (iv) neurological condition or systemic arthritis; (v) currently wearing a flat,flexible shoe for school; and (vi) any foot condition precluding the use of flat, flexible shoes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed. The assessor who determines eligibility will be unaware of which group the participant will be allocated to, and will remain blinded to group allocation throughout the study period. Allocation will be determined by an independent investigator, who will hold the allocation sequence and communicate each participant's group allocation to an unblinded assessor.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study will use simple randomisation, with the sequence generated by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A formal sample size calculation is not appropriate for feasibility trials. A sample of 24 participants will enable us to observe feasibility outcomes. Descriptive statistics will be used for the primary outcomes of feasibility. Estimates of i) group means and standard deviation of the secondary clinical outcomes, and ii) between-group differences in secondary clinical outcomes, with accompanying 95% confidence intervals, will be calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2022
Actual
6/05/2022
Date of last participant enrolment
Anticipated
Actual
3/02/2023
Date of last data collection
Anticipated
Actual
25/04/2023
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 35292 0
3216 - Waurn Ponds

Funding & Sponsors
Funding source category [1] 309674 0
University
Name [1] 309674 0
Deakin Univeristy
Country [1] 309674 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Road
Waurn Ponds
Victoria 3216 Australia
Country
Australia
Secondary sponsor category [1] 310693 0
Individual
Name [1] 310693 0
Dr Jason Bonacci
Address [1] 310693 0
Centre for Sports Research
Deakin University
75 Pigdons Road
Waurn Ponds
Victoria 3216 Australia
Country [1] 310693 0
Australia
Secondary sponsor category [2] 310695 0
Individual
Name [2] 310695 0
Dr Aaron Fox
Address [2] 310695 0
Centre for Sports Research
Deakin University
75 Pigdons Road
Waurn Ponds
Victoria 3216 Australia
Country [2] 310695 0
Australia
Secondary sponsor category [3] 310696 0
Individual
Name [3] 310696 0
Dr Natalie Saunders
Address [3] 310696 0
Centre for Sports Research
Deakin University
75 Pigdons Road
Waurn Ponds
Victoria 3216 Australia
Country [3] 310696 0
Australia
Secondary sponsor category [4] 310697 0
Individual
Name [4] 310697 0
Professor Bill Vicenzino
Address [4] 310697 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4072
Country [4] 310697 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309442 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 309442 0
Ethics committee country [1] 309442 0
Australia
Date submitted for ethics approval [1] 309442 0
Approval date [1] 309442 0
16/07/2021
Ethics approval number [1] 309442 0
2021-135

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

Contacts
Principal investigator
Name 114174 0
Dr Jason Bonacci
Address 114174 0
Centre for Sports Research
School of Exercise and Nutrition Sciences
Deakin University
75 Pigdons Road
Waurn Ponds
Victoria 3216
Country 114174 0
Australia
Phone 114174 0
+61 3 5227 2634
Fax 114174 0
Email 114174 0
jason.bonacci@deakin.edu.au
Contact person for public queries
Name 114175 0
Jason Bonacci
Address 114175 0
Centre for Sports Research
School of Exercise and Nutrition Sciences
Deakin University
75 Pigdons Road
Waurn Ponds
Victoria 3216
Country 114175 0
Australia
Phone 114175 0
+61 3 5227 2634
Fax 114175 0
Email 114175 0
jason.bonacci@deakin.edu.au
Contact person for scientific queries
Name 114176 0
Jason Bonacci
Address 114176 0
Centre for Sports Research
School of Exercise and Nutrition Sciences
Deakin University
75 Pigdons Road
Waurn Ponds
Victoria 3216
Country 114176 0
Australia
Phone 114176 0
+61 3 5227 2634
Fax 114176 0
Email 114176 0
jason.bonacci@deakin.edu.au

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 individual participant data collected during the trial
When will data be available (start and end dates)?
After publication, no end date determined
Available to whom?
Access to this data will be determined on a case-by-case basis at the discretion of Primary Investigator
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access to the data will be subject to approval by Principal Investigator (email: jason.bonacci@deakin.edu.au), with a requirement to sign a data access agreement.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFlat flexible school shoes for adolescents with patellofemoral pain: a randomised, assessor-blinded, parallel-group feasibility trial.2023https://dx.doi.org/10.1136/bmjsem-2023-001717
N.B. These documents automatically identified may not have been verified by the study sponsor.