Parkinson's disease
Conditions
Interventions
Reality DTx®, a class I CE marked medical device, is a software application for
AR headsets, such as HoloLens 2 and Magic Leap 2. The intended use of the
Reality DTx® software is to provide visual a
Sponsors
Vrije Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 21 years or older - Have command of the Dutch language - Diagnosed with PD according to the UK PD Brain Bank criteria (stages 1-3 on the Hoehn and Yahr scale) Additionally for persons with PD in the clinical feasibility study a person must experience: - Bothersome gait or balance impairments (i.e., negatively affecting their ability to perform their usual daily activities)
Exclusion criteria
Exclusion criteria: - Inability to comply with the protocol, i.e. additional neurological diseases and/or orthopaedic problems seriously interfering with gait function, insufficient physical capacity (e.g., frequent faller) or severe cognitive impairments (as observed by the researcher or clinician) - Severe visual or hearing impairments (after corrective aids) - Inability to walk independently for 30 minutes (in bouts of 5-10 minutes) - Severe visual hallucinations or illusions Additionally for persons with PD in the clinical feasibility study: - No stable dosage of medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters for the data quality study are outcome measures of gait and balance derived from AR headsets and a validated reference systems. The main study parameters for the intensity study are intensity of the gait-and-balance exercises using percentage of maximal heart rate and rating of perceived exertion. The main study parameters of the clinical feasibility study to evaluate home-based gamified cueing-assisted personalized AR gait-and-balance exercises with Reality DTx® are feasibility (in terms of safety, adherence, performance and user experience) and effectiveness (in terms of gait-and-balance outcome measures of standard clinical tests). | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
Netherlands
Contacts
Public ContactD.J. Geerse
Vrije Universiteit
Outcome results
None listed