Parkinson's Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • age > 18 years Participants in the PD-FOG group should additionally meet the following criteria: • idiopathic Parkinson’s Disease fulfilling the UK Brain Bank criteria • experiencing freezing of gait minimally twice a day. This is defined as a score of 1 on question 1 “have you experienced freezing of gait in the past month” on the New Freezing of Gait Questionnaire (NFOGQ), and at least one freezing of gait episode has been observed by a parkinsonnet-registered physiotherapist, neurologist or one of our clinical researchers.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Significant cognitive impairments. This is defined as a score on the mini mental state examination (MMSE (30)) equal to or smaller than 14, or a score on the frontal assessment battery (FAB(31)) of equal to or smaller than 13. • Comorbidities that cause severe gait impairment (e.g. severe arthrosis or neuropathy) • Inability to lie supine for the duration of the test period • Inability to walk 150 meters unaided • Severe visual impairments preventing the participant from using the virtual reality display
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are ‘freezing severity’, ‘step time variability variability’, ‘modal footstep latency’, ‘motor initiation’ and ‘stopping performance ‘. The study parameters are contrasted between: 1) Cue responsiveness (during VR foot pedalling and overground walking), and 2) the correlation between freezing during overground walking and VR foot pedalling; both uncued and visually cued. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: association of freezing during VR pedalling with subjective FOG severity, and user experience with the paradigm. Other study parameters measured are: age, Hoehn-Yahr-stage, UPDRS part III score, and scores on the mini mental state examination (MMSE) and frontal assessment battery (FAB). | — |