Exergaming Using Postural Feedback From Wearable Sensors and Exercise Therapy to Improve Postural Balance in People With Nonspecific Low Back Pain: Protocol for a Factorial Pilot Randomized Controlled Trial

BACKGROUND: Physical exercise is a common treatment for people with low back pain (LBP). Wearable sensors that provide feedback on body movements and posture during exercise may enhance postural balance and motor control in people with LBP. OBJECTIVE: This study aims to investigate whether physical exercising with postural feedback (EPF) improves postural balance, motor control, and patient-reported outcomes in people with LBP. METHODS: The study was an assessor-blinded 2×2 factorial trial. We planned to recruit 80 participants with nonspecific LBP who did not receive treatment for LBP. In addition, we aimed to recruit 40 patients with chronic, nonspecific LBP who were receiving exercise therapy (ET) at the University Hospital Zurich. Both ET patients and participants without treatment were randomized to receive either an additional EPF intervention or no additional intervention. This resulted in four different combinations of interventions: ET+EPF, ET, EPF, and no intervention. The participants underwent outcome assessments at inclusion (T1); 3 weeks later, at randomization (T2); after an intervention period of 3 weeks with a predefined exercise schedule for participants receiving EPF (T3); and after an additional 6 weeks, during which participants assigned to the EPF groups could exercise as much as they wished (T4). Patients receiving ET completed their regularly prescribed therapies during the study period. Balance was assessed during quiet standing on a force platform, and motor control was assessed during a lifting task and a waiter’s bow task. Physical activity was recorded using an activity tracker and the participants’ mobile phones during the study. The predefined EPF schedule consisted of nine sessions of 20 minutes of exercise with a tablet and inertial measurement unit sensors at home. Participants performed a series of trunk and hip movements and received feedback on their movements in a gamified environment displayed on the tablet. RESULTS: The first participant was recruited in May 2019. Data collection was completed in October 2020, with 3 patients and 32 eligible people without therapy who passed the eligibility check. CONCLUSIONS: Although it will not be possible to investigate differences in patients and people without other therapies, we expect this pilot study to provide insights into the potential of EPF to improve balance in people with LBP and adherence to such interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26982