Effectiveness and therapeutic compliance of digital therapy in shoulder rehabilitation: a randomized controlled trial

Background: Interactive videogames, virtual reality, and robotics represent a new opportunity for multimodal treatments in many rehabilitation contexts. However, several commercial videogames are designed for leisure and are not oriented toward definite rehabilitation goals. Among the many, Playball® (Playwork, Alon 10, Ness Ziona, Israel) is a therapeutic ball that measures both movement and pressure applied on it while performing rehabilitation games. This study aimed: (i) to evaluate whether the use of this novel digital therapy gaming system was clinically effective during shoulder rehabilitation; (ii) to understand whether this gaming rehabilitation program was effective in improving patients' engagement (perceived enjoyment and self-efficacy during therapy; attitude and intention to train at home) in comparison to a control non-gaming rehabilitation program. Methods: A randomized controlled experimental design was outlined. Twenty-two adults with shoulder pathologies were recruited for a rehabilitation program of ten consecutive sessions. A control (CTRL; N = 11; age: 62.0 ± 10.9 yrs) and an intervention group (PG; N = 11; age: 59.9 ± 10.2 yrs) followed a non-digital and a digital therapy, respectively. The day before (T0) and after (T1) the rehabilitation program, pain, strength, and mobility assessments were performed, together with six questionnaires: PENN shoulder Score, PACES-short, Self-efficacy, Attitudes to train at home, Intention to train at home, and System usability scale (SUS). Results: MANOVA analysis showed significant improvements in pain (p < 0.01), strength (p < 0.05), and PENN Shoulder Score (p < 0.001) in both groups. Similarly, patients' engagement improved, with significant increments in Self-efficacy (p < 0.05) and attitude (p < 0.05) scores in both groups after the rehabilitation. Pearson correlation showed significant correlations of the Δ scores (T1 - T0) between PACES and Self-efficacy (r = 0.623; p = 0.041) and between PACES and Intention to train at home (r = 0.674; p = 0.023) only in the PG. SUS score after the rehabilitation (74.54 ± 15.60) overcame the cut-off value of 68, representative of good usability of a device. Conclusions: The investigated digital therapy resulted as effective as an equivalent non-digital therapy in shoulder rehabilitation. The reported positive relationship between the subject's enjoyment during digital therapy and intention to train at home suggests promising results in possible patient's exercise engagement at home after the rehabilitation in the medical center. Retrospectively registered: NCT05230056.