The effectiveness of customised 3D-printed insoles on perceived pain, comfort, and completion time among frequent Park Runners: Study protocol for a pragmatic randomised controlled trial (The ZOLES RCT).

Running, a popular recreational activity, often leads to the experience of pain and discomfort among participants impacting performance and participation longevity. The ZOLES trial evaluates customised 3D-printed insoles for reducing pain in frequent parkrunners aged 35 and over. An innovative process of foot-scanning and responses to questions relating to size, pain, discomfort, and previous medical conditions are combined leading to the production of personalised 3D-printed orthotics. The ZOLES trial is a pragmatic, outcome assessor blinded, randomised, controlled, superiority trial involving 200 recreational runners, randomised to receive either customised 3D-printed insoles (ZOLES) or to a "do-as-usual" control group. The study follows a robust protocol, ensuring adherence to established guidelines for clinical trials, and is based at St Mary's University, Twickenham, London. The primary outcome is change in running-related pain over a 10-week period, assessed using an 11-point Numeric Rating Scale. Secondary outcomes include overall pain and discomfort, running-related comfort, 5k-completion time, time-loss due to injuries, running exposure, and adherence to the intervention. A balanced-block randomisation process is stratified by sex and parkrun location, and an intention-to-treat analyses will be employed on all outcomes in the primary trial report. The trial includes a 52-week post-market surveillance to assess long-term effects of the customised insoles. The ZOLES trial aims to provide insights into real-world applicability and effectiveness of customised 3D-printed insoles in reducing running-related pain and enhancing overall running experience. Despite the limitation of a subjective primary outcome measure without participant blinding, the methodological rigor, including external outcome assessment and data handling, we anticipate results that are academically credible and applicable in real-world settings The results of this trial may have important implications for runners, clinicians, and the sports footwear industry, as evidence for the use of individualised insoles to improve running experience and prevention of pain may become evident. The trial was pre-registered at ClinicalTrials.gov with the trial identifier NCT06034210 on September 4, 2023, and publicly posted on September 13, 202

Validity of a low-cost inertial measurement unit for the assessment of range and quality of movement of cervical and thoracic spine

Background and aims: Patients with spinal pain frequently consult clinical practice because of movement impairments and decreased motor control, which can be challenging to assess in a clinical setting. Inertial measurement sensors may provide an opportunity for developing reliable, affordable, and simple methods for detecting and monitoring spine motion in a clinical context. This study aimed to examine the validity and reliability of an inertial sensor with a 3D camera system for measuring range of motion (ROM) and quality of movement (QOM) in single-plane neck and trunk motions.Methods: Thirty-three healthy, pain-free individuals took part in the study. Each participant performed neck (cervical flexion, extension, and lateral flexion) and trunk (thoracic flexion, extension, rotation, and lateral flexion) movements, which were recorded simultaneously using a 3D camera system and an inertial measuring unit (MOTI, Aalborg, Denmark). For ROM and QOM (quantified as the jerk index), agreement and consistency were assessed using intraclass correlation coefficients (ICC3.1), mean bias, and Bland-Altman plots.Results: The reliability of ROM was excellent for all movements (ICC3.1 between 0.91 and 1.00) and good to excellent for QOM (ICC3.1 between 0.84 to 0.95). The average bias for all motions was less than the minimum acceptable difference between devices (0.1-0.8°). According to the Bland-Altman plot, MOTI measured higher ROM and QOM than the 3D camera system for all neck and trunk motions.Conclusions: This study showed that MOTI was a reliable and valid method for assessing ROM and QOM for neck and trunk motions in experimental and clinical settings