About this trial
Virtual Reality (VR) is gaining traction as a new and innovative leisure to augment healthcare services. Several benefits of the leisure experience, such as distraction and full sensory immersion, have demonstrated a potential to significantly impact the field of healthcare through pain reduction, anxiety reduction, and is seen as an innovative approach to motor learning. Persons with ALS (pwALS) have a high prevalence of anxiety over the course of their illness, which has a negative impact on their quality of life, and the quality of life of those closest to them. The use of VR for anxiety management and subsequent quality of life improvement has yet to be explored in the ALS population.
For individuals with ALS, VR can be both (1) an escape from the reality of living day to day with a progressive fatal diagnosis; and (2) the opportunity to potentially improve anxiety, both of which are linked to the quality of life of individuals living with ALS. Our hypothesis is that a simple and accessible home VR-guided relaxation exercise program can improve subjective anxiety symptoms in a person living with ALS and subsequently improve quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with ALS (gold coast or El-Escorial), or ALS variants of flail limb, progressive muscle atrophy, UMN or LMN predominant
Able to use VR device with no negative effects (i.e. headaches, vision changes, dizziness, nausea, disorientation)
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Virtual Reality Guided Breathing Exercise
BehavioralHome-based guided breathing exercise using a virtual reality system application.
Treatment groups
Trial outcomes
Primary outcomes
State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
The STICSA is a self-report questionnaire consisting of 42-items rated on a 4-point Likert scale from 1 (Almost never or Not at all) to 4 (Almost always or Very much so), where 21 items are rating how you feel in the present moment, and the same 21 items are rated based on how you feel in general
Secondary outcomes
ALS Functional Rating Scale - Revised (ALSFRS-R)
The ALS Functional Rating Scale (ALSFRS) is a validated rating instrument for monitoring the progression of disability in persons with ALS. The Revised ALSFRS (ALSFRS-R) retains the properties of the original scale and shows strong internal consistency and construct validity. The scale consists of 12 items, each with 5 possible responses rating impairment level, and covers various aspects of daily living
ALS-Specific Quality of Life Short Form (ALSSQOL-SF)
The Amyotrophic Lateral Sclerosis-Specific Quality of Life Short Form (ALSSQOL-SF) is a 20-item disease-specific global QOL instrument that has a short administration time suitable for clinical use, and can provide clinically useful, valid information about persons with ALS. Items are scored using a 0-10 rating scale.
Patient Global Impression of Improvement Scale (PGI-I)
Patient global impression of improvement (PGI-I) is a single-item global rating of change scale that asks an individual to rate the severity of a specific condition at baseline or to rate at endpoints the perceived change in his/her condition in response to therapy. There are seven possible responses (scored 1-7): very much better, much better, a little better, no change, a little worse, much worse, and very much worse
Locations
Sponsors and contacts
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Horizon Health Network
Lead sponsor
University of Saskatchewan
Collaborator
Nova Scotia Health Authority
Collaborator
Hamilton Health Sciences Corporation
Collaborator
Queen's University, Kingston, Ontario
Collaborator
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