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

NCT06590987 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Strolll AR

Strolll AR is an augmented-reality (AR) neurorehabilitation platform for delivering gait and balance exercises (assisted with cues when deemed beneficial) for Parkinson's disease onto state-of-the-art AR glasses.

Sponsors & Collaborators

  • VU University of Amsterdam

    lead OTHER

Principal Investigators

  • Melvyn Roerdink, PhD · Department of Human Movement Sciences, Vrije Universiteit Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-18
Primary Completion
2025-02-21
Completion
2025-02-27

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06590987 on ClinicalTrials.gov