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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50616

Enrollment

Registered

2018-12-03

Start date

2019-02-06

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 controls and of the Hololens during walking, pre-FOG and FOG episodes for PD patients. Additional main study parameters for the Holocue efficacy study 1, Holocue efficacy study 2 and technical validation study are the number and duration of FOG episodes (as annotated by the research assistants, as measured with the Hololens and as predicted by the generic and patient-tailored classification algorithms). Other study parameters include clinical test scores, demographic and clinical parameters, and parameters related to usability and patient friendliness.	—

Measure

Time frame

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 controls and of the Hololens during walking, pre-FOG and FOG episodes for PD patients. Additional main study parameters for the *Holocue efficacy study 1*, *Holocue efficacy study 2* and *technical validation study* are the number and duration of FOG episodes (as annotated by the research assistants, as measured with the Hololens and as predicted by the generic and patient-tailored classification algorithms). Other study parameters include clinical test scores, demographic and clinical parameters, and parameters related to usability and patient friendliness.

—

Secondary

Measure	Time frame
Clinical test scores, demographic and clinical parameters, and parameters related to usability and patient friendliness	—

Countries

Netherlands

Outcome results