Technology in Motion (TIM) - Project Holocue Towards on-demand and assist-as-needed patient-tailored cues to alleviate and prevent freezing of gait

Completed

Conditions: Parkinson's Disease
10028037

Registration Number: NL-OMON50616

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 66

Inclusion Criteria

Healthy controls: 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: 18 years or older,
male/female, have command of the Dutch language, diagnosed with PD according to
the UK PD Brain Bank criteria, experience FOG in the dopaminergic ON state.

Exclusion Criteria

Healthy controls: neurological diseases and/or orthopedic 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: additional neurological diseases and/or orthopedic 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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Spatiotemporal gait parameters (e.g., walking speed, cadence, step length, step<br /><br>time) calculated from the walking data of the Hololens and a reference motion<br /><br>capture system for healthy controls and of the Hololens during walking, pre-FOG<br /><br>and FOG episodes for PD patients. Additional main study parameters for the<br /><br>Holocue efficacy study 1, Holocue efficacy study 2 and technical<br /><br>validation study are the number and duration of FOG episodes (as annotated by<br /><br>the research assistants, as measured with the Hololens and as predicted by the<br /><br>generic and patient-tailored classification algorithms). Other study parameters<br /><br>include clinical test scores, demographic and clinical parameters, and<br /><br>parameters related to usability and patient friendliness.</p><br>

Secondary Outcome Measures