Technology in Motion (TIM) - Project Holocue: Towards on-demand and assist-as-needed patient-tailored cues to alleviate and prevent freezing of gait
- Conditions
- Parkinson's disease
- Registration Number
- NL-OMON24506
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
Healthy subjects (n = 23)
- 18 years or older
- male/female
- have command of the Dutch language
- normal gait function
- normal cognitive function (MoCA score = 26)
- normal or corrected to normal vision
PD patients (n = 39)
- 18 years or older
- male/female
- have command of the Dutch language
- registered at the LUMC
- diagnosed with PD according to the UK PD Brain Bank criteria
- experience FOG in the dopaminergic ‘ON state’
Healthy subjects (n = 23)
- neurological diseases and/or orthopaedic problems interfering with gait function
- inability to comply with the protocol, i.e. insufficient general fitness or cognitive/communicative inability to understand instructions and participate in the measurement
PD patients (n = 39)
- additional neurological diseases and/or orthopaedic problems seriously interfering with gait function
- inability to comply with the protocol, i.e. insufficient general fitness or cognitive/communicative inability to understand instructions and participate in the measurement
- inability to walk independently, visual hallucinations or illusions
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study parameters are spatiotemporal gait parameters (e.g., walking speed, cadence, step length, step time) calculated from the walking data of the HoloLens and a reference motion capture system for healthy subjects and PD patients and of the HoloLens during walking, pre-FOG and FOG episodes for PD patients. Additional main study parameters for the ‘Holocue efficacy study 1’ and ‘Holocue efficacy study 2’ are the number and duration of FOG episodes (as annotated by the research assistants, as measured with the Hololens and as predicted by the classification algorithm).
- Secondary Outcome Measures
Name Time Method Secondary study parameters include clinical test scores, demographic and clinical parameters, and parameters related to usability and patient friendliness.