Virtual Reality for Anxiety Management in Persons With Amyotrophic Lateral Sclerosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHorizon Health Network

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality Guided Breathing Exercise

    Behavioral

    Home-based guided breathing exercise using a virtual reality system application.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Virtual Reality relaxation therapyExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
At baseline and repeated at 4 weeks, 8 weeks and 12 weeks.

Secondary outcomes

1

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

Time frame
Baseline and 12 weeks.
2

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.

Time frame
Baseline, 4 weeks, 8 weeks and 12 weeks.
3

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

Time frame
Completed at 12 week assessment only.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: