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


- candidate number26715
- NTR NumberNTR6409
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2017
- Secondary IDsNL60687.044.17 METC Twente
- Public TitleVirtual visual cues to reduce freezing in Parkinson’s disease: an explorative study
- Scientific TitleVirtual visual cues to reduce freezing in Parkinson’s disease: an explorative study
- ACRONYM-
- hypothesisFreezing of gait (FOG) is a particularly disturbing and potentially harmful symptom occurring in a majority of people with Parkinson's Disease (PD) over the course of disease. External cues, such as a metronome or bars on the floor, aid in timing and scaling of automatized movement, thereby facilitating initiation and continuation of gait. The mechanism behind visually cued movement has not been fully elucidated. The cerebellar-thalamo-cortical (CTC) network is likely involved in synchronizing movement with an external rhythm, but has not been studied in patients with PD and FOG (PD-FOG). ln this study, we aim to validate a paradigm to be used in future neuroimaging studies investigating the neuronal networks underlying visually cued movement. ln addition, this behavioural experiment explores whether moving visual cues in a virtual reality (VR) environment can improve motor timing and reduce freezing in persons with PD-FOG.
- Healt Condition(s) or Problem(s) studiedParkinson's disease, Parkinsonian gait, Freezing of gait
- Inclusion criteriaIn 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 criteriaA 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2017
- planned closingdate1-apr-2018
- Target number of participants35
- Interventionsthe 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. The secondary objective is to assess the influence of virtual visual cues on freezing and motor timing ability in persons with PD and FOG.
- Primary outcomeThe 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 outcomeSecondary 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).
- TimepointsExperiments are conducted during a single visit to the University of Twente.
- Trial web sitenone
- statusplanned
- CONTACT FOR PUBLIC QUERIES Sabine Janssen
- CONTACT for SCIENTIFIC QUERIES Sabine Janssen
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryFreezing of gait (FOG) is a particularly disturbing and potentially harmful symptom occurring in a majority of people with Parkinson's Disease (PD) over the course of disease. External cues, such as a metronome or bars on the floor, aid in timing and scaling of automatized movement, thereby facilitating initiation and continuation of gait. The mechanism behind visually cued movement has not been fully elucidated. The cerebellar-thalamo-cortical (CTC) network is likely involved in synchronizing movement with an external rhythm, but has not been studied in patients with PD and FOG (PD-FOG). ln this study, we aim to validate a paradigm to be used in future neuroimaging studies investigating the neuronal networks underlying visually cued movement. ln addition, this behavioural experiment explores whether moving visual cues in a virtual reality (VR) environment can improve motor timing and reduce freezing in persons with PD-FOG.
- Main changes (audit trail)
- RECORD16-feb-2017 - 5-jul-2017


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