|- candidate number||28951|
|- NTR Number||NTR7254|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-mei-2018|
|- Secondary IDs||NL66241.044.18 METC Twente|
|- Public Title||Augmented reality turning-cues in Parkinson’s Disease|
|- Scientific Title||Augmented Reality cues to reduce Freezing of Gait during turning in persons with Parkinson’s disease |
|- hypothesis||Visual cues, presented in augmented reality can reduce the severity of freezing of gait evoked during turning in patients with Parkinson’s disease. This reduction is significantly stronger for visual cues than for conventional auditory cues, as well as for a control condition without cueing.|
|- Healt Condition(s) or Problem(s) studied||Parkinson's disease, Freezing of gait, Turning problems|
|- Inclusion criteria||• Age > 18 years|
• Diagnosed with idiopathic Parkinson’s disease according to the UK Brain Bank Criteria
• Written informed consent
• Presence of FOG (defined as a score of 1 on question 1 from the NFOGQ: “have you ever experienced FOG in the past month?”)
• Disabling/regular FOG (defined as a score of 3 “Very often, more than one time a day” on question 2 from the NFOGQ: “How often do you experience FOG?”)
• Normal or corrected to normal vision.
|- Exclusion criteria||• Comorbidities that cause severe gait impairment (e.g. severe arthrosis or neuropathy)|
• Comorbidities that cause severe vision impairment (e.g. severe maculopathy)
• Severe cognitive impairments (MMSE <24) or or a score on the frontal assessment battery (FAB) of equal to or smaller than 13.
• Inability to perform a 180 degree turn around the axis unaided (e.g.: without the help of a walking aid or the direct help of a person).
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-jun-2018|
|- planned closingdate||1-jun-2019|
|- Target number of participants||16|
|- Interventions||A comparison will be made amongst 4 cueing conditions: |
Visual cueing: Using a Microsoft HoloLens, a brand of smartglasses, there are cues displayed on top of the real environment. The cues will reflect the turn-progress and balance of the participant using data from accelerometers and pressure insoles. The cues will be automatically turned off after turn completion (180 degrees).
Auditory cueing: A high-pitch high-frequency metronome will sound, assisting the participant during the turning movement. Turn progression will be registered using data from the Xsens sensors: after turning 180-degrees, the turn is completed and the cueing will stop automatically.
Combined cueing: A combination of the described auditory and visual cues will appear and will be automatically turned off after turn completion.
No cueing: the participant is wearing the HoloLens but does not receive any cues.
|- Primary outcome||The main endpoint is FOG severity, as defined by the parameters: fraction of time spent with freezing; number of freezing episodes; duration of freezing. The occurrence of FOG is determined by evaluation of the video recordings by two independent trained raters. The FOG severity will be compared amongst the different cueing conditions.|
|- Secondary outcome||A secondary endpoint is quantification of the turns with parameters of interest: lateral weight shifting; turn duration; cadence; step time; step height; footstep latency; motor initiation and stopping performance. Another secondary endpoint is the association of FOG parameters obtained from the video recordings, with FOG detection parameters calculated using data from the accelerometers.|
|- Timepoints||not applicable|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Jaap de Ruyter van Steveninck|
|- CONTACT for SCIENTIFIC QUERIES|| Jaap de Ruyter van Steveninck|
|- Sponsor/Initiator ||University of Twente|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background: Freezing 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 the disease. FOG symptoms are predominantly evoked by turning around and remain difficult to treat with pharmacological management and/or surgical treatment. The use of external cues, such as auditory, tactile or visual stimuli, have shown to be a valuable strategy to prevent or overcome freezing. There is preliminary evidence that visual cueing is effective for preventing FOG during turning, and in terms of effectiveness, visual cues might be favorable over auditory cues. However, the feasibility of mobile visual cueing, and the benefit compared to auditory cueing needs to be investigated further.|
In the current study we use smart glasses to present interactive visual cues in augmented reality, aimed at reducing freezing of gait during turning around. We compare 4 cueing conditions (visual cues; auditory cues; a combination of visual and auditory cues; and no cues) to determine optimal ambulant management of freezing symptoms.
Study design: This is an explorative behavioral study aimed at investigating the feasibility of using visual cueing in AR for alleviating FOG symptoms during turning in persons with PD. All procedures are non-invasive. The experiments require a single 2,5-3 hour visit to our laboratory in Enschede.
The turning experiments are split in two sessions, consisting of 4 blocks each. In each block, lasting maximally 4.5 minutes, the subject performs 15 trials. In every trial, the participant is required to make 180-degree turns ’on the spot’. There will be a different cueing condition per block: participants will receive either auditory cues; visual cues in AR; both auditory and visual cues; or no cues. Within each block, the cueing condition is held constant. The order of the blocks within each session (i.e. the order of the different cueing conditions) will be pseudo-randomized to control for the influence of training or tiredness.
Study population: 16 subjects that are diagnosed with Parkinson’s disease and experience regular freezing of gait (i.e. on average, more than once per day). Subjects must be able to walk without walking aid, must have normal or corrected to normal vision and must have no cognitive.
Main study parameters/endpoints: The main endpoint is FOG severity, as defined by the parameters: fraction of time spent with freezing; number of freezing episodes; duration of freezing. The occurrence of FOG is determined by evaluation of the video recordings by two independent trained raters. The FOG severity will be compared amongst the different cueing conditions.
|- Main changes (audit trail)|
|- RECORD||28-mei-2018 - 13-jun-2018|