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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Patellofemoral pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

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]

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]

Assessed at completion of data collection

Secondary outcome [1]

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]