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

Abstract

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

Feedback on Trunk Movements From an Electronic Game to Improve Postural Balance in People With Nonspecific Low Back Pain: Pilot Randomized Controlled Trial

“…The completed CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) checklist [ 43 ] is provided in Multimedia Appendix 1 [ 2 - 12 , 20 , 22 , 32 , 39 - 42 , 44 - 50 ]. The intervention is described according to the TIDieR (Template for Intervention Description and Replication) checklist [ 51 ].…”

“…This manuscript was based on a study protocol [ 44 ] that included a 2-arm randomized controlled trial. Figure 1 shows the assessment and intervention schedule.…”

“…The published study protocol [ 44 ] contained a further research question involving an additional patient group. We intended to compare the effect of the intervention between a group of patients and other participants who did not receive other treatments than the exercise intervention with postural feedback.…”

“…Otherwise, Wilcoxon rank-sum tests were used. The a priori power analysis is reported within the study protocol [ 44 ]. We calculated post hoc power for the primary comparison using G*Power (Heinrich Heine Universität Düsseldorf) [ 65 ].…”

The Association of Fear of Movement and Postural Sway in People with Low Back Pain

“…We describe secondary analyses of data from a randomized controlled trial which investigated the effects of an exergame for people with LBP on postural sway (Meinke et al, 2021(Meinke et al, , 2022. Data of 2 baseline assessments taken about 3 weeks apart were used (visit 1 and 2).…”