Dataset Information

RCT protocol for driving performance in people with Parkinson's using autonomous in-vehicle technologies.

ABSTRACT:

Introduction

Driving is an essential facilitator of independence, community participation, and quality of life. Drivers with Parkinson's Disease (PD) make more driving errors and fail on-road evaluations more than healthy controls. In-vehicle technologies may mitigate PD-related driving impairments and associated driving errors. Establishing a rigorous study protocol will increase the internal validity and the transparency of the scientific work.

Methods

We present a protocol to assess the efficacy of autonomous in-vehicle technologies (Level 1) on the driving performance of drivers with PD via a randomized crossover design with random allocation. Drivers with a PD diagnosis based on established clinical criteria (N = 105), referred by neurologists, are exposed to two driving conditions (technology activated or not) on a standardized road course as they drove a 2019 Toyota Camry. The researchers collected demographic, clinical, on-road data observational and kinematic, and video data to understand several primary outcome variables, i.e., number of speeding, lane maintenance, signaling, and total driving errors.

Discussion

The protocol may enhance participant adherence, decrease attrition, provide early and accurate identification of eligible participants, ensure data integrity, and improve the study flow. One limitation is that the protocol may change due to unforeseen circumstances and assumptions upon implementation. A strength is that the protocol ensures the study team executes the planned research in a systematic and consistent way.Following, adapting, and refining the protocol will enhance the scientific investigation to quantify the nuances of driving among those with PD in the era of automated in-vehicle technologies.

Trial registration

ClinicalTrials.gov NCT04660500.

SUBMITTER: Classen S

PROVIDER: S-EPMC9256542 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BACKGROUND:Parkinson's disease is one of the most frequent causes of disability among the older adults. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease. Therefore, physiotherapy becomes an important intervention for the management of motor disorders. Originally, these rehabilitative approaches were based on empirical experiences, but several scientific evidences suggests that neuronal plasticity is exercise-dependent. In this context, robotic rehabilitation plays an important role because it allows to perform task-oriented exercises and to increase the number of repetitions and their intensity. This protocol study aims to evaluate the effectiveness of robotic-based intervention of the older adults with Parkinson's disease, designed to improve the gait and to reduce the risk of falling. METHODS:This study is a single-blinded randomized controlled trial. The primary outcomes are: risk of falling, gait performance and fear of falling measured through Performance-Oriented Mobility Assessment (POMA), instrumental gait analysis and Short Falls Efficacy Scale - International (FES-I), respectively. One hundred ninety-five patients with PD will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation using Tymo system or Walker View in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6?months, 1?year and 2?years from the end of the treatment. A 10-treatment session will be conducted, divided into 2 training sessions per week, for 5?weeks. The control group will perform traditional therapy sessions lasting 50?min. The technological intervention group will carry out 30?min of traditional therapy and 20?min of treatment with a robotic system. DISCUSSION:The final goals of the present study are to propose a new approach in the PD rehabilitation, focused on the use of robotic device, and to check the results not only at the end of the treatment but also in the long term. TRIAL REGISTRATION:NCT04087031, registration date September 12, 2019.

Project description:BackgroundMany community-dwelling individuals living with a disability use mobility assistive technologies (MATs). MAT devices are generally beneficial for individuals with mobility impairments. However, less is known about the specific factors that may foster or deter mobility and community participation.ObjectiveThe purpose of this protocol is to describe the methodology for a study including three main objectives: (1) to understand the places people using MAT go and the things they do, (2) to identify perceived barriers and facilitators as well as users' desired environmental modifications, and (3) to understand subjective and objective issues related to environmental accessibility.MethodsA mixed-methods study was conducted in Vancouver and in Quebec City. Qualitative interviews were conducted to address all three objectives. In addition, Objective 1 was achieved through collection of global positioning system (GPS) data and activity diaries with 36 participants per site who represented six types of MAT users (ie, cane, walker, crutches, manual wheelchair, power wheelchair, and scooter). All participants were invited to take part in all aspects of data collection. PhotoVoice was used to address Objectives 2 and 3. Two environmental audits were used to address Objective 2. The Stakeholders' Walkability/Wheelability Audit in Neighbourhood (SWAN) measured perceptions related to a variety of community environmental features associated with mobility and participation. A total of 24 participants were recruited to each study site for SWAN data collection. The Measure of Environmental Accessibility (MEA) was also used to objectively measure access to exterior and interior environments selected earlier in the project by the participants that could benefit from improvements.ResultsFunding for this study was obtained from the Social Sciences and Humanities Research Council of Canada. Approval was obtained from the University of British Columbia Research Ethics Board and the Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale Research Ethics Board. Regarding the MEA evaluations, 19 locations (ie, buildings and exterior spaces) where obstacles have been identified by the participants of the PhotoVoice focus groups have been evaluated in Quebec City and 20 locations have been identified in the Vancouver region by the participants of the community forums. Data collection for this project was completed in December 2018. Analysis and writing of manuscripts are underway.ConclusionsThe use of a variety of methods to gather data on participation and mobility will allow a more holistic consideration of factors influencing mobility with a MAT device. This study will provide objective information about the mobility of participants and identify barriers and facilitators that impact their mobility and community participation. Through the mixed-methods approach employed in this study, we will gain a subjective evaluation of the participants' neighborhoods, including personally meaningful information on environmental features that influence participants' everyday mobility and participation. We will also gain an objective evaluation of particular obstacles that community users of MAT identify as significant barriers to their ability to access public environments. We anticipate that these findings will help to identify a broad spectrum of solutions to improve the mobility and community participation of MAT users.International registered report identifier (irrid)DERR1-10.2196/12089.

Project description:Marine protected areas (MPAs) are designed to reduce threats to biodiversity and ecosystem functioning from anthropogenic activities. Assessment of MPAs effectiveness requires synchronous sampling of protected and non-protected areas at multiple spatial and temporal scales. We used an autonomous underwater vehicle to map benthic communities in replicate 'no-take' and 'general-use' (fishing allowed) zones within three MPAs along 7o of latitude. We recorded 92 taxa and 38 morpho-groups across three large MPAs. We found that important habitat-forming biota (e.g. massive sponges) were more prevalent and abundant in no-take zones, while short ephemeral algae were more abundant in general-use zones, suggesting potential short-term effects of zoning (5-10 years). Yet, short-term effects of zoning were not detected at the community level (community structure or composition), while community structure varied significantly among MPAs. We conclude that by allowing rapid, simultaneous assessments at multiple spatial scales, autonomous underwater vehicles are useful to document changes in marine communities and identify adequate scales to manage them. This study advanced knowledge of marine benthic communities and their conservation in three ways. First, we quantified benthic biodiversity and abundance, generating the first baseline of these benthic communities against which the effectiveness of three large MPAs can be assessed. Second, we identified the taxonomic resolution necessary to assess both short and long-term effects of MPAs, concluding that coarse taxonomic resolution is sufficient given that analyses of community structure at different taxonomic levels were generally consistent. Yet, observed differences were taxa-specific and may have not been evident using our broader taxonomic classifications, a classification of mid to high taxonomic resolution may be necessary to determine zoning effects on key taxa. Third, we provide an example of statistical analyses and sampling design that once temporal sampling is incorporated will be useful to detect changes of marine benthic communities across multiple spatial and temporal scales.