Condition or disease | Intervention/treatment | Phase |
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Parkinson Disease Virtual Reality Gait Disorders, Neurologic Long Range Autocorrelations | Device: Virtual reality headset | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Immersive Virtual Reality on Treadmill to Ecologically Assess Parkinson's Disease Patients' Gait |
Actual Study Start Date : | April 10, 2019 |
Actual Primary Completion Date : | September 19, 2019 |
Actual Study Completion Date : | September 19, 2019 |
Arm | Intervention/treatment |
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Experimental: Parkinson's Disease patients
Parkinson's Disease patients will walk in three conditions for +- 15 minutes per condition: walking over ground, walking on a treadmill, walking on a treadmill in virtual reality
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Device: Virtual reality headset
All participants will walk in the three conditions described earlier in this form
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
PD patients:
Exclusion Criteria:
PD Patients:
Belgium | |
Cliniques Universitaires Saint Luc | |
Brussel, Belgium, 1200 |
Principal Investigator: | Thierry Lejeune, PhD | Cliniques universitaires Saint-Luc |
Tracking Information | |||||
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First Submitted Date ICMJE | May 9, 2019 | ||||
First Posted Date ICMJE | July 15, 2019 | ||||
Last Update Posted Date | May 6, 2020 | ||||
Actual Study Start Date ICMJE | April 10, 2019 | ||||
Actual Primary Completion Date | September 19, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Long-Range Autocorrelations [ Time Frame: Change from baseline in long-range autocorrelations during each intervention condition (3 x 10 min walking) ] Long-Range Autocorrelations
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effects of iVR Treadmill on Gait in PD | ||||
Official Title ICMJE | Immersive Virtual Reality on Treadmill to Ecologically Assess Parkinson's Disease Patients' Gait | ||||
Brief Summary | Parkinson's Disease (PD) patients suffer from gait impairments responsible for falls and bad quality of life: reduced speed and stride length, randomness in stride duration variability (reduced Long-Range Autocorrelations (LRA)). This pilot study will compare the spatio-temporal walking parameters and LRA of PD patients tested under three conditions: walking over ground, walking on a treadmill and walking on a treadmill in virtual reality. The aim is to determine the effect on gait of an optical flow recreated in virtual reality, by means of a virtual reality headset, on a treadmill. | ||||
Detailed Description |
2.1 Participants : 10 patients suffering from idiopathic Parkinson's Disease will be recruited from the local community and from the Neurology and the Physical and Rehabilitation Medicine outpatient clinics of the Cliniques universitaires Saint-Luc (Woluwe-Saint-Lambert, Belgium). 2.2 Functional assessment: Before the expermientations starts, all participants will undergo a non harmful assessment including clinical tests and questionnaires PD patients: Age, height, weight, sex, most affected side, Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS), Mini Balance Evaluation Systems Test (Mini-BESTest), Simplified version of the Activities-specific Balance Confidence Scale (ABC-Scale), modified Hoehn & Yahr scale, Mini Mental State Examination (MMSE). 2.3 Procedure : Every participants will walk in three conditions in a randomized order. Each condition lasted ±15 minutes in order to get 512 gait cycles mandatory to assess the presence of LRA. The first condition consists in Over ground Walking (OW). Participants will be asked to walk on an rectangular track with rounded corner of 63.2 meters in CUSL at their comfortable walking speed. The second condition is Treadmill Walking (TW). Patients will walk on the treadmill at their comfortable walking speed assessed before the condition with a 10 Meter Walk Test. During this condition, patients will wear a non weight-bearing safety harness (Petzl, Volt, France). The last condition consists in walking on a treadmill, at the same speed as during TW, patients still wearing the non weight-bearing harness, while wearing a VR headset (VRTW). The VR headset (HTC, Vive, Taïwan) consists of a kind of mask that the person comes to put on his face. Two Fresnel lenses are in front of the person's eyes and the person looks at a display that allows stereoscopic 3D through these lenses. The patient is then immersed in an immersive virtual environment, cut off from the outside world. For this experiment, a VR environment has been created by means of Unity software and using C# code. While walking on the treadmill, the participants will see a quiet hallway surrounding them. The participants will perceive an optic flow while walking on the treadmill. The speed of the optic flow perceived inside the headset by the patient will be matched with the speed of the treadmill to create the illusion of walking on an actual hallway. A cybersickness questionnaire (Simulator Sickness Questionnaire, SSQ) will be completed before and just after VRTW. Indeed, the use of a VR headset can cause dizziness, nausea, headaches and other symptoms in some patients. We want to evaluate whether or not the use of an optical flow displayed in VR on a treadmill leads to cybersickness. 2.4 Data acquisition: Two Inertial Measurement Units (IMU) (IMeasureU Research, VICON, USA) will be taped on patients' both lateral malleoli. IMUs will be taped on the leg on the side most affected by the disease. This system allowed to record ankle accelerations at 500 Hz. The data will then be put on a computer and each peak of acceleration, corresponding to each heel strike, will be detected by software internally developed to determine all stride durations. 2.5 Gait assessment: Data will be extracted from 512 consecutive gait cycles which is required to measure gait variability. 2.5.1 Spatiotemporal gait variables: Mean gait speed, gait cadence and stride length will be measured as follow: Mean gait speed (m.s-1) = Total walking distance (m)/ Acquisition duration (s) Gait cadence (#steps.min-1) = Total number of steps (#)/Acquisition duration (min) Step length (m) = Gait speed (m/s)*60/Gait cadence (steps/min) 2.5.2 Stride duration variability : Stride duration variability can be assessed 2 ways: in terms of magnitude or in terms of organization (how stride duration evolves across consecutive gait cycles). 2.5.2.1 Magnitude of the stride duration variability : To determine the effect of the RAS on the magnitude of the stride duration variability during 512 gait cycles, the mean, the standard deviation (SD) and the coefficient of variation (CV = [SD/mean] * 100) will be assessed. 2.5.2.2 Temporal organization of the stride duration variability (LRA) : Temporal organization of stride duration variability will be assessed by LRA computation using the evenly spaced averaged version of the Detrended Fluctuation Analysis (DFA) to obtain α exponent. The presence of LRA can be shown with α exponent values between 0.5 and 1. Data will be treated by the mean of CVI Labwindows (C++). 2.6 Statistical analyses : Statistical analyses will be conducted using Sigmaplot 13. If the normality test is passed, a one-way repeated measures ANOVA will be applied to determine the effect of the various walking condition on spatiotemporal gait parameters (gait speed, gait cadence, stride length) and on linear and nonlinear measures of stride duration variability (CV, SD, H and α exponents). When a significant difference between groups is detected with the ANOVA, a post hoc test will be performed to compare each mean with the other means to isolate the groups from each other. A paired t-test will also be conducted to determine a possible change in score on the SSQ questionnaire after TW and after VRTW. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE |
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Intervention ICMJE | Device: Virtual reality headset
All participants will walk in the three conditions described earlier in this form
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Study Arms ICMJE | Experimental: Parkinson's Disease patients
Parkinson's Disease patients will walk in three conditions for +- 15 minutes per condition: walking over ground, walking on a treadmill, walking on a treadmill in virtual reality
Intervention: Device: Virtual reality headset
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
10 | ||||
Original Estimated Enrollment ICMJE |
40 | ||||
Actual Study Completion Date ICMJE | September 19, 2019 | ||||
Actual Primary Completion Date | September 19, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: PD patients:
Exclusion Criteria: PD Patients:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04019158 | ||||
Other Study ID Numbers ICMJE | NMSK - Lheureux 02 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||||
Study Sponsor ICMJE | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||||
Verification Date | May 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |