|- candidate number||21694|
|- NTR Number||NTR5157|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-feb-2015|
|- Secondary IDs||NL50755.044.15 METC Twente|
|- Public Title||SmartGlasses for freezing of gait in Parkinson’s disease|
|- Scientific Title||SmartGlasses for freezing of gait in Parkinson’s disease|
|- hypothesis||We have developed a cueing application (app) for the Google Glass platform that can guide gait in PD-patients. Our initial observations showed that external cueing with the Google Glass application decreased the number and duration of FOG episodes compared to walking tasks without Google Glass, when tested in a laboratory setting. In principle therefore, smart glasses technology could be used to implement cueing strategies and as such facilitate goal-based therapy training to improve gait and gait-related activities of patients with PD. It remains the question whether the positive impact of external cueing by smart glasses in a laboratory setting generalizes to daily life. Therefore, in the current study we will test the ability of the Google Glass to provide patients with successful cueing, during three one week periods of home-based measurements. We expect that cueing by Google Glass decreases the occurrence of FOG compared to conservative cues (such as a metronome or walker with laser-device) and a baseline period without cueing. |
|- Healt Condition(s) or Problem(s) studied||Parkinson's disease, Gait pattern|
|- Inclusion criteria||• Men/women of age > 18 years with idiopathic Parkinson’s disease, as diagnosed by the UK Brain Bank Criteria (Hughes et al. , 1992). |
• Written informed consent.
• Presence of FOG (defined as a score of 1 on question 1 "Have you experienced FOG in the past month" from the NFOGQ).
• Disabling/regular FOG (defined as a score of 3 "Very often, more than one time a day" on question 2 "How often do you experience FOG" from the NFOGQ).
• Patients need to use conservative cues in daily life.
|- Exclusion criteria||• Presence of stroke in history or a psychiatric disease.|
• Severe visual impairments.
• Severe co-morbidity (such as orthopedic problems) limiting ambulation.
• Severe cognitive impairments (MMSE<24).
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-apr-2015|
|- planned closingdate||1-jul-2017|
|- Target number of participants||26|
|- Interventions||• The main objective of this study is to assess the functional efficacy of external cueing, provided by Google Glass, on walking performance and occurrence of FOG. For this purpose, we will perform home-based gait registrations using an ambulatory activity monitor (XSens), to compare the occurrence of FOG during three consecutive periods of one week; 1) in the absence of cueing, 2) in the presence of conservative cueing devices (such as a metronome); 3) in the presence of cueing by Google Glass. We will apply a previously validated algorithm on the data of the activity monitor to detect the occurrence and duration of FOG episodes (Delval et al., 2010). The number and duration of FOG episodes will be examined.|
|- Primary outcome||• The statistical design will focus on the comparison of the number of FOG episodes between the three one-week periods with and without cueing. Application of a previously validated algorithm to detect FOG episodes and comparison of the three periods will determine the functional efficacy of the Google Glass on FOG in the home environment.|
|- Secondary outcome||• Evolution of walking activity over days, falls and presence of FOG episodes will be examined with the help of the patients' diaries. |
• Effect on quality of life (PDQ39), walking speed (10 meter walking test and Timed-Up and Go-test) and activities of daily living (Nottingham Extended Activities of Daily Living Index).
• Patients subjective impression of external cueing by Google Glass and conservative cues on a 5 points Likert scale (major impairment - minor impairment - no effect - minor improvement - major improvement).
• The Frontal Assessment Battery score will be used as a covariate in all performed analyses.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Jorik Nonnekes|
|- CONTACT for SCIENTIFIC QUERIES|| Jorik Nonnekes|
|- Sponsor/Initiator ||University of Twente|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||18-feb-2015 - 31-mei-2015|