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Virtual visual cues to reduce freezing in Parkinson’s disease: an explorative study

Virtual visual cues to reduce freezing in Parkinson’s disease: an explorative study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21397
Enrollment
35
Registered
2017-02-16
Start date
2017-04-01
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

the main objective of this study is to validate a VR foot pedalling paradigm to study visual cueing and freezing of gait in patients with PD-FOG, to allow for its use in future neuroimaging studies.

Sponsors

University of Twente
Lead Sponsor

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

MeasureTime 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

MeasureTime 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).

Contacts

Public ContactSabine Janssen
s.janssen-2@utwente.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)