Abstract
IMPORTANCE: Physical therapy is moving toward digitally supported, independent, home-based care to improve therapy accessibility and adherence. OBJECTIVE: This trial evaluated the clinical feasibility and potential effectiveness of Strolll, an augmented reality (AR) neurorehabilitation platform offering gamified gait-and-balance exercises with optional assistive AR cueing for individuals with Parkinson disease, implemented in real-world clinical practice. DESIGN AND SETTING: In this pragmatic clinical trial, 15 Dutch health care practices were onboarded, 28 therapists trained, and 100 individuals with Parkinson disease (Hoehn and Yahr stages 1-3) included. All participants followed the T0-usual-care-control-T1-Strolll-intervention-T2 procedure. INTERVENTION: The Strolll intervention consisted of 2-week supervised in-clinic training followed by 6 weeks, 5 sessions per week of 30 active minutes each, independent home-based training. RESULTS: No serious adverse events occurred; only 2 non-injurious falls were reported in >60.000 exercise minutes. Adherence was high (96% session adherence, 91% active minutes/session adherence). Therapists prescribed the program progressively, with significantly higher game-play levels over time. Participants' exercise performance increased over time. Participants and therapists rated user experience and technology acceptance positively. Timed "Up & Go" test and 10-meter walk test (10MWT) (fast speed) scores improved significantly after the intervention period only. Five times sit-to-stand test, 10MWT (comfortable speed), and Mini Balance Evaluation Systems Test scores improved after both usual-care and intervention periods. Falls Efficacy Scale-International scores showed no significant improvements. AR cueing was deemed beneficial for a subset of participants. CONCLUSIONS: Strolll is a safe, adherable, progressive, usable, and well-accepted therapist-managed, home-based intervention for people with Parkinson disease, with the potential to improve gait, balance, and fall-risk indicators. Findings on the integration of AR cueing highlight the importance of an individualized approach. RELEVANCE: Implementing AR rehabilitation technologies like Strolll in the clinical pathway is feasible, offering a safe and scalable way for individuals to train independently, potentially improving accessibility of care and broadening its use to physical activity promotion. CLINICAL TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov (NCT06590987).