NCT06590987: CAPARE

Cueing-assisted Gamified Augmented-reality Gait-and-balance Rehabilitation at Home for People With Parkinson's Disease

Completed NA Last updated 6 April 2025

What this trial tests

NA trial testing Strolll AR in Parkinson Disease in 100 participants. Completed in 27 February 2025.

Timeline

18 April 2024

Primary endpoint
21 February 2025

27 February 2025

Quick facts

Lead sponsor	VU University of Amsterdam
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	18 April 2024
Primary completion	21 February 2025
Estimated completion	27 February 2025
Sites	1 location across Netherlands

Drugs / interventions tested

• Strolll AR

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

VU University of Amsterdam

Who can join

21 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Physiotherapy in the clinic is highly recommended for improving gait, balance and falls risk in people with Parkinson's disease. In addition, technology may help boost unsupervised exercise hours at home. Strolll is an augmented-reality (AR) neurorehabilitation platform for delivering gait-and-balance exercises onto AR glasses that can be performed under direct supervision of the therapist in the clinic, but also independently at home. Strolll AR also has the option to integrate AR cueing in gait-and-balance exercises to assist people with more severe mobility impairments in performing the exercises. The objective of this pragmatic randomized controlled trial (RCT) on Strolll AR is to examine its clinical feasibility and effectiveness for improving indicators of gait, balance and falls risk. A secondary objective is to evaluate procedures for tailoring assistive AR cues.

Methods: 80-100 people with Parkinson's disease (Hoehn and Yahr stages 1-3) with gait and/or balance impairments will participate in this study. This study is a pragmatic RCT in which all participants follow the same procedure. After a baseline assessment (T0), participants will start with a 6-week usual care control period, followed by a midterm assessment (T1). Subsequently, participants will undergo two weeks of in-clinic familiarization with Strolll AR. Then, participants will start with the 6-week Strolll AR intervention at home, followed by a final in-clinic assessment (T2). The primary study parameters are feasibility (i.e., safety, adherence, performance and user experience) and effectiveness for improving indicators of gait, balance and falls risk. For the statistical analyses on effectiveness, participants will be allocated to control (using T0-T1 change data) or intervention (using T1-T2 change data) groups using multiple (n=20) randomizations. Recruitment started in May 2024 and the last T2 assessment is expected in January 2025.

Discussion: The design of this particular pragmatic RCT will demonstrate feasibility and effectiveness in a real-world setting and in a representative population. Strolll AR may facilitate the transition from supervised care in the clinic to independent care at home, providing a platform for delivering individualized treatment, assisted with AR cues when deemed beneficial, for improving gait, balance and falls risk in people with Parkinson's disease.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cueing-assisted gamified augmented-reality gait-and-balance rehabilitation at home for people with Parkinson's disease: protocol of a pragmatic randomized controlled trial implemented in the clinical pathway.
   Geerse DJ, Hoogendoorn EM, van Doorn PF, van Bergem JS, et al · · 2025 · cited 2× · PMID 40066314 · DOI 10.3389/fneur.2025.1512409
2. Cueing-assisted gamified augmented-reality home rehabilitation for gait and balance in people with Parkinson disease: feasibility and effectiveness in the clinical pathway.
   Hoogendoorn EM, Geerse DJ, van Dam AT, van Hall SJ, et al · · 2026 · PMID 41665260 · DOI 10.1093/ptj/pzag012