Immediate effects of hip strap and foot orthoses on self-reported measures and lower limb kinematics during functional tasks in individuals with patellofemoral osteoarthritis: protocol for a randomised crossover clinical trial.

BACKGROUND: Elevated patellofemoral joint stress has been associated with patellofemoral osteoarthritis (PFOA). Changes in lower limb kinematics, such as excessive femoral adduction and internal rotation and excessive rearfoot eversion during the stance phase of functional activities, may increase patellofemoral stress. There is a lack of studies that assess the effects of interventions for controlling femur and subtalar joint movements during functional activities on self-reported measures in individuals with PFOA. Thus, the primary aim of the study is to determine the immediate effects of the hip strap and foot orthoses during level-ground walking and the single-leg squat test on self-reported outcomes. The secondary aim is to investigate whether the hip strap and foot orthoses result in the kinematic changes that these devices are purported to cause. METHODS: Twenty-nine individuals with PFOA aged 50 years or older will take part in the study. The main outcome is pain intensity. The secondary outcomes are other self-reported measures (global rating of change, acceptable state of symptoms, ease of performance, and confidence) and lower limb kinematics (peak femoral adduction and internal rotation, and peak rearfoot eversion). These outcomes will be assessed during functional tasks performed under three conditions: (i) control condition, (ii) hip strap intervention, and (iii) foot orthoses intervention. To investigate whether these interventions result in the lower limb kinematic changes that they are purported to cause, three-dimensional kinematics of the femur and rearfoot will be captured during each task. Linear mixed models with two fixed factors will be used to test associations between the interventions (control, hip strap, and foot orthoses) and conditions (level-ground walking and single-leg squat test) as well as interactions between the interventions and conditions. DISCUSSION: To the best of the authors' knowledge, this is the first study to evaluate the immediate effects of the hip strap and foot orthoses on self-reported measures and lower limb kinematics during functional tasks in individuals with PFOA. The findings of this study will enable future trials to investigate the effects of these interventions in rehabilitation programmes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04332900 . Registered on 3 April 2020.