Just... Breathe: Virtual Reality Guided Breathing Exercise for Anxiety Management in Amyotrophic Lateral Sclerosis
Phase: NA
Conditions: ALS (Amyotrophic Lateral Sclerosis)
Sponsor: Horizon Health Network

 
 
 
 
 
 
 
 
 
 
Just... Breathe: Virtual Reality Guided Breathing Exercise for Anxiety Management in Amyotrophic 
Lateral Sclerosis 
 
 
 
Principal Investigator: 
Dr. Colleen M. O’Connell 
Research Chief 
Stan Cassidy Centre for Rehabilitation 
drcolleenoconnell@horizonnb.ca 
 
Co-Principal Investigator: 
Kerri Schellenberg 
Associate Professor of Neurology 
University of Saskatchewan 
kerri.schellenberg@usask.ca 
 
Co-Investigator(s): 
Lauren E. Casey 
Research Department 
Stan Cassidy Centre for Rehabilitation 
Lauren.casey@horizonnb.ca 
 
Shane A. McCullum 
Research Department 
Stan Cassidy Centre for Rehabilitation 
Shane.a.mccullum@horizonnb.ca 
 
JoAnne Savoie 
Psychologist 
Stan Cassidy Centre for Rehabilitation 
Joanne.savoie2@horizonnb.ca  
 
 
 
 
Version: July 17th, 2025 
 
 

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Additional Co-Investigators: 
 
1. Suzanne Salsman, MD, Research Director, Division of Physical Medicine and Rehabilitation; Assistant 
Professor, Department of Medicine, Dalhousie University; Suzanne.Salsman@nshealth.ca  
2. Benjamin Ritsma, MD, Assistant Professor, Queen’s University; Clinical Director, Rehabilitation 
Providence Care Hospital, Kingston, Ontario, Canada; ritsmab@providencecare.ca  
3. Marvin Chum, MD, Associate Professor of Neurology, Department of Medicine, McMaster University; 
mchum@stjoes.ca  
 
 
 

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PROTOCOL SUMMARY  
 
 
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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Just... Breathe: Virtual Reality Guided Breathing Exercise for Anxiety Management in Amyotrophic 
Lateral Sclerosis 
 
Background 
Amyotrophic lateral sclerosis (ALS) is a neuromuscular disease characterized by death of motor neurons, 
resulting in weakness1. Aside from motor-related progressive impairment, persons with ALS (pwALS) 
experience a burden of non-motor symptoms which have major influences on quality of life (QOL)2. This 
includes anxiety, found to be only second to function as greatest influence on QOL3, and autonomic dysfunctions 
such as dyspnea, heart rate variability, and dizziness. Such autonomic dysfunctions are also symptoms often 
experienced with anxiety4. The prevalence of anxiety in persons with ALS ranges from 20.5-67.6%, is shown to 
fluctuate over the course of the illness, and is recognized to have a negative effect on the quality of life of not 
only those affected, but also their caregivers2,5. A study by Marconi and colleagues6 identified that late-stage 
ALS patients exhibited high levels of anxiety, while a study by Vignola et al.7 found higher anxiety levels during 
the diagnostic and early stages of the disease. Despite its high prevalence and presence over the course of illness, 
anxiety is not always a properly addressed aspect of ALS, with limited literature regarding interventions8. As 
anxiety has been shown to have a causal relationship that can lead to decreased quality of life3,9, further research 
is essential to find methods to reduce anxiety and subsequently improve QOL for persons with ALS.  
Quality of life (QOL) is defined by the World Health Organization as an “individual’s perception of their 
position in life in the context of the culture and value systems in which they live and in relation to their goals, 
expectations, standards and concerns” (“WHO | WHOQOL”). Included in this definition is the person’s physical 
health, psychological state, personal beliefs, social relationships, and relationships with salient features of the 
environment. High levels of physical disability are linked to a lower predictor of quality of life, and with a 
neuromuscular disease such as ALS, an individual’s ability to engage with their community and environment 
deteriorates, resulting in fewer opportunities to engage in leisure and recreation that have a direct implication on 
one’s quality of life11,12. Any recreation opportunity that offers an element of enjoyment and freedom should be 
explored12. 
Exploring alternative technologies to improve access to anxiety management strategies for pwALS is a worthy 
endeavor. Virtual Reality (VR) is a technology increasingly used for mental health treatment and within clinical 
research13. The virtual reality aspect allows for the person to be fully immersed in a relaxing environment with 
visual and auditory stimuli which has relaxation effects similar to meditation14. Anxiety treatment interventions 
utilizing VR can include exposure therapy or applied relaxation techniques, two of the more promising 
treatments for generalized anxiety disorder, often promoting similar results to such traditional techniques15-18. 
VR facilitates the applied relaxation intervention by visually presenting key relaxing images to the subjects19. 
The visual presentation of a virtual calm scenario can facilitate a persons' practice and mastery of relaxation, 
making the experience more vivid and real than the one that most individuals can create using their own 
imagination and memory19. 
Despite the increasing use of VR in the treatment of various mental health diagnoses, the use of VR in pwALS is 
innovative20. Currently, there is very limited research available exploring the effects of using VR relaxation 

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techniques on anxiety or QOL in pwALS. As VR is increasingly shown to provide benefits for the user, 
additional research is required to identify benefit to this population.  
 
The Present Study 
This study will identify if a simple and accessible home VR guided relaxation exercise program can improve 
subjective anxiety symptoms in persons living with ALS, subsequently improving quality of life. 
Hypothesis 
Engaging in a simple and accessible home-based virtual reality (VR) guided relaxation exercise 
program will show a reduction in subjective anxiety symptoms and subsequent improvement in quality 
of life in persons with ALS. 
 
 
 

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METHODS 
 
Participants  
At 5 sites across Canada (Fredericton NB, Halifax NS, Kingston ON, Hamilton ON, and Saskatoon SK), persons 
with Amyotrophic Lateral Sclerosis will be identified by their treating physician and invited to participate during 
a typical interdisciplinary ALS clinic visit at their respective healthcare centre.  
Sample Size and Power Analysis 
Literature with similar interventions with ALS patients shows effect sizes ranging from zero (no effect) to 
medium (f  = .25), so a median effect size of f = .175 gives good balance between null and medium effect21. With 
an alpha of .05 and 80% power, power analysis with the median effect size of f = .175 and 4 outcome 
assessments while accounting for a 20-30% attrition rate puts the required sample size at 60 participants across 
the 5 participating sites. Participants will be randomized through block randomization methods into either 
control or intervention groups (6 control and 6 intervention participants per site).  
Inclusion criteria: 
- 
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) 
Exclusion criteria: 
- 
Cognitive impairment that impacts ability to participate fully in assessments  
 
Timeframe 
 
Pending REB approvals, data sharing agreements, and equipment procurement, we anticipate starting recruitment 
in Fall 2025. We anticipate this project to be completed within 24 months. Subjects 1-30 are planned to be recruited 
and complete the study within an 8–9-month timeframe, as well as subjects 31-60, with some overlap. Considering 
time for recruitment struggles or dropouts, data analysis, and dissemination, this will bring us to 21-24 months for 
total project completion. 
 
Measures/Materials  
Participants will be provided with a VR Oculus Meta Quest 3 device with the ‘Tripp’ guided breathing 
application installed, a paired tablet for casting their screen to allow caregivers to aid the user if needed, and a 
VR usage log. Assessments used will include the State Trait Inventory for Cognitive and Somatic Anxiety 
(STICSA), ALS Functional Rating Scale – Revised (ALSFRS-R), ALS-Specific Quality of Life Short Form 
(ALSSQOL-SF), and Patient Global Impression of Improvement Scale (PGI-I). These will be used to assess 
participant anxiety, global functions, quality of life, and whether they are perceiving any changes in such areas, 
respectively. 
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 general22. The validity of the STICSA has 
been examined in many different cases23,24, as well examined with different age groups25,26. A study done with an 
elderly sample stated “The STICSA also showed evidence of discriminating anxious symptoms from physical 

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health symptoms”25. The STICSA has also been compared against the well-known State-Trait Anxiety Inventory 
anxiety measure, finding that STICSA has better convergent validity with measures of somatic anxiety23.  
The ALS Functional Rating Scale (ALSFRS) is a validated rating instrument for monitoring the progression of 
disability in persons with ALS27. The Revised ALSFRS (ALSFRS-R) retains the properties of the original scale 
and shows strong internal consistency and construct validity27. The scale consists of 12 items, each with 5 
possible responses rating impairment level, and covers various aspects of daily living27. ALSFRS-R scores 
correlate significantly with quality of life as measured by the Sickness Impact Profile, indicating that the quality 
of function is a strong determinant of quality of life in ALS27. It is a primary outcome measure used in clinical 
trials of ALS because it is validated, easy to administer, minimizes dropout, reduces cost, and correlates with 
survival28.  
 
The Amyotrophic Lateral Sclerosis-Specific Quality of Life instrument and its revised version (ALSSQOL and 
ALSSQOL-R) have strong psychometric properties and have demonstrated research utility29. To reduce 
assessment time, we will utilize the short-form version in this study (ALSSQOL-SF). Compared with the 
ALSSQOL-R, optimal precision was retained, and psychometric properties for the ALSSQOL-SF and its 
subscales were strong29. The 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 ALS29. Items are scored using a 0-10 rating scale29.  
 
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 therapy30. 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 worse30. The PGI-I can provide 
an overall patient-centric appraisal of their own condition30. We will be using it alongside the other measures 
mentioned above to assess change. 
 
Copies of all assessments are included in the Appendix. 
 
Procedure 
Once participants are referred from their physician to research team members, the study will proceed as follows:  
1. At baseline visit, participants will meet with a member of the research team at their respective site for 
informed consent discussion and collection of general demographic information such as sex, age, time since 
ALS diagnosis, and other diagnoses as some may affect results (i.e. diagnosed and/or treated mental health 
history). All participants will complete the STICSA, ALSFRS-R, and the ALSSQOL-SF to obtain baselines for 
state trait anxiety, current functional ability, and quality of life, respectively. If randomized to the intervention 
group, participants will complete training with the VR equipment through tutorial videos and research team 
guidance.  
2. Participants in the intervention group will receive the VR headset and instructions to take home and be asked 
to use the app 3x/week while maintaining a VR usage log. Participants in the control group will be advised to 
carry on as normal.  
3. At the end of Week 4, all participants will be contacted via telephone to repeat the STICSA and ALSSQOL-
SF, and intervention group participants will have a technology check-in.  
4. At the end of Week 8, all participants will be contacted again via telephone to repeat the STICSA and 
ALSSQOL-SF, and intervention group participants will have a technology check-in.  

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5. At the end of Week 12, participants will be seen in clinic or home for the end-of-study visit, where they will 
complete the STICSA, ALSFRS-R, ALSSQOL-SF, PGI-I, and general study wrap-up activities (i.e., equipment 
return). As a thank you for participating, those in the control group will have the opportunity to trial a VR guided 
breathing session if they wish. If in the control group and do not wish to trial VR, this step may be done over the 
phone. 
6. At participants’ next ALS clinic 3 months post-study or over the phone, a follow-up will be conducted to 
ensure participants have no major declines in function or mental status. Participants will complete the STICSA, 
ALSFRS-R, and ALSSQOL-SF. 
 
Study Design 
 
This study is a prospective randomized controlled trial (RCT). 
 
Sampling Procedures 
The primary site of this project is Stan Cassidy Centre for Rehabilitation, a tertiary neurorehabilitation centre in 
Fredericton, New Brunswick. However, participants will be recruited at additional healthcare sites in Nova 
Scotia, Ontario, and Saskatchewan. Eligible participants will be identified by their treating physician and invited 
to participate during a typical interdisciplinary ALS clinic visit at their respective healthcare centre. The 
physician will give a brief description of the project and ask permission for a research team member to contact 
them about participation and conduct informed consent discussions. Block randomization method will assign 
consenting participants at each site to either the intervention or control group.  
There will be no financial compensation for participation as there are no costs or financial burdens on 
participants in this study. As a thank you to the participants in the control group, they will be allowed to trial the 
VR guided breathing sessions after completion of their follow-up visit. 
Specification of the Variables under Investigation 
 
The independent variable in this study is the introduction or absence of the VR-guided relaxation exercise 
program. The dependent variable is participant’s subjective anxiety symptoms and consequently quality of life. 
Outcome variables will include the STICSA, ALSFRS-R, ALSSQOL-SF, and PGI-I.  
 
Data Collection, Storage, and Retention 
 
Data collection and assessments will be conducted by research team members, including research assistants and 
coordinators under the primary and co-applicants’ supervision, who all have training certifications in place 
regarding confidentiality, privacy, and research ethics. Baseline collection will be completed in-person after ALS 
clinics. Assessments done at Weeks 4 and 8 will be completed over the phone. Final assessment and wrap-up 
will be completed in-person either at home or in clinic, or over the phone if part of the control group who do not 
wish to come in and trial the VR. Final follow-up visit will be conducted either in clinic or over the phone. 
 
Sites may conduct assessments on paper or enter responses directly into RedCap, which is a secure, web-based 
software platform designed for building and managing online surveys and databases.. Each site will be provided 
with study access to RedCap for data entry, with analysis being completed at the lead site following completion 
of the study.  
 

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The primary study site is Stan Cassidy Centre for Rehabilitation in Fredericton, N.B. Any local paper study 
documentation will be kept in a double-locked cabinet within the SCCR Research Office accessible only to 
members of the research team at SCCR. Data at all sites will be de-identified and collected on encrypted 
computers with password protected data files and kept safely at their respective sites. Data sharing agreements 
will be drafted between the primary site and all other sites for safe transfer over email once collection is 
complete. Data analysis will be conducted by the primary site’s research team. Once completed, the data will be 
transferred onto an encrypted USB drive or computer. Any documentation and USB drive will be archived for 7 
years after the study's completion and then destroyed.  
 
Proposed Data Analysis 
Participant demographic information will be described using descriptive statistics. There will be consideration of 
demographic statistics when comparing outcome measures between groups (i.e. variations in sex, age, function) 
if the groups do not have similar profiles, though we are aiming for equivalent grouping.  
Comparative analysis looking at the interaction effect between intervention and control groups over time using a 
mixed repeated-measures analysis of variance (mixed RM-ANOVA) will be performed to determine statistical 
differences in score outcomes of the STICSA, ALSSQOL-SF, and PGI-I. Critical alpha will be set to 0.05 for all 
statistical tests. As the STICSA includes subscales measuring cognitive and somatic components of both state 
and trait anxiety, these subscales (state and trait) will be analyzed using RM-ANOVA separately in a two-factor 
model, as it has found to yield more robust, precise scoring and interpretation31. The ALSFRS-R will be used to 
assess disease progression pre- to post-study to ensure no major declines occurred during the study period and to 
gauge general functional ability of the participant population. Data visualization will be undertaken of all 
quantitative variables using histograms and other basic descriptive statistics (e.g., mean, maximum, count) and 
scatterplot graphs.  
 
 
 
 
 
 

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Conclusion 
This multi-site randomized controlled trial aims to identify if a simple and accessible at-home virtual 
reality guided relaxation exercise program can improve subjective anxiety symptoms in persons with ALS 
and subsequently improve quality of life. It is our hope that this project will not only raise mental health 
awareness in persons with ALS but also provide an accessible and affordable opportunity to manage these 
overlooked aspects of ALS. This work could potentially be applied to other diagnoses which influence 
mental health and quality of life if deemed effective.  
 
 

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major depressive disorder. Eur Psychiatry. 2018 Sep;53:17–22. 
31. Barros F, Figueiredo C, Brás S, Carvalho JM, Soares SC (2022) Multidimensional assessment of 
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https://doi.org/10.1371/journal.pone.0262960 
 
 

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Appendices 
 
• 
Appendix A: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA) 
• 
Appendix B: ALS Functional Rating Scale – Revised (ALSFRS-R) 
• 
Appendix C: ALS-Specific Quality of Life Short Form (ALSSQOL-SF) 
• 
Appendix D: Patient Global Impression of Improvement Scale (PGI-I) 
• 
Appendix E: Study Budget  
• 
Appendix F: Excel Data Collection Template (attached separately) 
 
 
 
 
 
 
 
 
 

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Appendix A – State Trait Inventory for Cognitive and Somatic Anxiety 
 
STICSA- TRAIT 
 
Below is a list of statements which can be used to describe how people feel. Beside each 
statement are four numbers which indicate how often each statement is true of you (eg, 1 = 
almost never, 4 = almost always). Please read each statement carefully and circle the number 
which best indicates how often, in general, the statement is true of you. 
 
 
Not at all 
A little 
Moderately 
Very much so 
1. My heart beats fast 
1 
2 
3 
4 
2. My muscles are tense 
1 
2 
3 
4 
3. I feel agonized over my 
problems 
1 
2 
3 
4 
4. I think that others won't 
approve of me 
1 
2 
3 
4 
5. I feel like I'm missing out 
on things because I can't 
make up my mind 
1 
2 
3 
4 
6. I feel dizzy 
1 
2 
3 
4 
7. My muscles feel tense 
1 
2 
3 
4 
8. I feel trembly and shaky 
1 
2 
3 
4 
9. I picture some future 
misfortune  
1 
2 
3 
4 
10. I can’t get some thought 
out of my mind 
1 
2 
3 
4 
11. I have trouble 
remembering things 
1 
2 
3 
4 

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12. My face feels hot 
1 
2 
3 
4 
13. I think the worst will 
happen 
1 
2 
3 
4 
14. My arms and legs feel stiff 
1 
2 
3 
4 
15. My throat feels dry 
1 
2 
3 
4 
16. I keep busy to avoid 
uncomfortable thoughts 
1 
2 
3 
4 
17. I cannot concentrate 
without irrelevant 
thoughts intruding 
1 
2 
3 
4 
18. I worry that I cannot 
control my thoughts as 
well as I would like to 
1 
2 
3 
4 
19. I worry that I cannot 
control my thoughts as 
well as I would like to 
1 
2 
3 
4 
20. I have butterflies in my 
stomach 
1 
2 
3 
4 
21. My palms feel clammy 
1 
2 
3 
4 
Column totals 
= 
= 
= 
= 
Total Score = 
 
 
 
 
 
 
 
 
 

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STICSA- STATE 
 
Below is a list of statements which can be used to describe how people feel. Beside each 
statement are four numbers which indicate the degree with which each statement is self-
descriptive of mood at this moment (e.g., 1 = not at all, 4 = very much so). Please read each 
statement carefully and circle the number which best indicates how you feel right now, at this 
very moment, even if this is not how you usually feel. 
 
 
Not at all 
A little 
Moderately 
Very much so 
1. My heart beats fast 
1 
2 
3 
4 
2. My muscles are tense 
1 
2 
3 
4 
3. I feel agonized over my 
problems 
1 
2 
3 
4 
4. I think that others won't 
approve of me 
1 
2 
3 
4 
5. I feel like I'm missing out 
on things because I can't 
make up my mind 
1 
2 
3 
4 
6. I feel dizzy 
1 
2 
3 
4 
7. My muscles feel tense 
1 
2 
3 
4 
8. I feel trembly and shaky 
1 
2 
3 
4 
9. I picture some future 
misfortune  
1 
2 
3 
4 
10. I can’t get some thought 
out of my mind 
1 
2 
3 
4 
11. I have trouble 
remembering things 
1 
2 
3 
4 

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12. My face feels hot 
1 
2 
3 
4 
13. I think the worst will 
happen 
1 
2 
3 
4 
14. My arms and legs feel stiff 
1 
2 
3 
4 
15. My throat feels dry 
1 
2 
3 
4 
16. I keep busy to avoid 
uncomfortable thoughts 
1 
2 
3 
4 
17. I cannot concentrate 
without irrelevant 
thoughts intruding 
1 
2 
3 
4 
18. I worry that I cannot 
control my thoughts as 
well as I would like to 
1 
2 
3 
4 
19. I worry that I cannot 
control my thoughts as 
well as I would like to 
1 
2 
3 
4 
20. I have butterflies in my 
stomach 
1 
2 
3 
4 
21. My palms feel clammy 
1 
2 
3 
4 
Column totals 
= 
= 
= 
= 
Total Score = 
 
 
 
 
 
 

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February 17, 2026 
 
 
 
 
Appendix B - Amyotrophic Lateral Sclerosis Functional Rating Scale – Revised 
(ALSFRS-R)        
 
Participant ID# ___________________ 
Date: __________________________ 
                        
 
QUESTIONS 
 
1. Speech 
 4 – Normal Speech processes 
 3 – Detectable speech with disturbances 
 2 – Intelligible with repeating 
 1 – Speech combined with nonvocal 
communication  
 0 – Loss of useful speech 
 
2. Salivation 
 4 – Normal 
 3 – Slight but definite excess of saliva in mouth; 
may have nighttime drooling 
 2 – Moderately excessive saliva; may have 
minimal drooling 
 1 – Marked excess of saliva with some drooling 
 0 – Marked drooling; requires constant tissue or 
handkerchief 
 
3. Swallowing 
 4 – Normal eating habits 
 3 – Early eating problems – occasional choking 
 2 – Dietary consistency changes 
 1 – Needs supplemental tube feeding 
 0 – NPO (exclusively parenteral or enteral 
feeding) 
 
4. Handwriting 
 4 – Normal 
 3 – Slow or sloppy; all words are legible 
 2 – Not all words are legible 
 1 – Able to grip pen but unable to write 
 0 – Unable to grip pen 
 
5. Does subject have gastrostomy? 
 No – Answer 5a 
 Yes – Answer 5b 
 
 
 
 
 
 
 
 
 
 
a. Cutting Food and Handling Utensils 
(patients without gastrostomy) 
 4 – Normal 
 3 – Somewhat slow and clumsy, but no help 
needed 
 2 – Can cut most foods, although clumsy and 
slow; some help needed 
 1 – Food must be cut by someone, but can 
still feed slowly 
 0 – Needs to be fed

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5.  (cont.) 
b. Cutting Food and Handling Utensils (alternate scale for patients with gastrostomy) 
 4 – Normal 
 3 – Clumsy but able to perform all manipulations independently 
 2 – Some help needed with closures and fasteners 
 1 – Provides minimal assistance to caregivers 
 0 – Unable to perform any aspect of task 
 
6. Dressing and Hygiene 
 4 – Normal function 
 3 – Independent and complete self-care with effort or decreased efficiency 
 2 – Intermittent assistance or substitute methods 
 1 – Needs attendant for self-care 
 0 – Total dependence 
 
7. Turning in bed and adjusting bed clothes 
 4 – Normal 
 3 – Somewhat slow and clumsy, but no help needed 
 2 – Can turn alone or adjust sheets, but with great difficulty 
 1 – Can initiate, but not turn or adjust sheets alone 
 0 – Helpless 
 
8. Walking 
 4 – Normal 
 3 – Early ambulation difficulties 
 2 – Walks with assistance 
 1 – Nonambulatory functional movement only 
 0 – No purposeful leg movement 
 
9. Climbing Stairs 
 4 – Normal 
 3 – Slow 
 2 – Mild unsteadiness or fatigue 
 1 – Needs assistance 
 0 – Cannot do 
 
 
 

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Appendix C - ALS-Specific Quality of Life Short Form (ALSSQOL-SF) 
 
 
Participant ID# ____________________ 
 
Date: __________________________ 
 
 
Instructions:  
 
The questions in this questionnaire begin with a statement followed by two opposite answers. Numbers 
extend from one extreme answer to its opposite. Please circle the number between 0 and 10 which is 
most true for you. There are no right or wrong answers. Completely honest answers will be most helpful. 
 
 
 
 
 
 
 
 
 
Please assess your overall quality of life over the past week (7 days): 
 
 
Very 
bad 
 
 
 
 
 
 
 
 
 
Excellent 
Considering 
all 
parts of my life – 
physical, 
emotional, social, 
spiritual, 
and 
financial – over the 
past 
week, 
the 
quality of my life 
has been. 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 

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February 17, 2026 
 
 
 
 
 
Please rate the following symptoms and experiences according to how much of a problem each one has 
been for you. Please respond about how you have felt or what you have experienced over the past week 
using the scale provided. 
 
 
 
No 
Problem 
 
 
 
 
 
 
 
 
 
Tremendous 
Problem 
1. 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
2. 
Fatigue 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
3. 
Excessive 
Saliva 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
4. 
Speaking 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
5. 
My 
Strength 
and 
Ability to 
Move 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
6. 
Sleep 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Please rate the following statements according to how strongly you agree or how strongly you disagree 
with each of them. Please respond about how you have felt or what you have experienced over the past 
week. 
 
 
 
Strongly 
Disagree 
 
 
 
 
 
 
 
 
 
Strongly 
Agree 
7. 
I have felt 
physically 
terrible 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
8. 
The world 
has been 
caring and 
responsive 
to 
my 
needs 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
9. 
I have felt 
supported 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Please rate the following statements according to how much you have felt or experienced what is 
described. Please respond about how you have felt or what you have experienced over the past week. 
 
 
 
Not at 
all 
 
 
 
 
 
 
 
 
 
Very 
much 
10. 
I 
have 
been 
depressed 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

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February 17, 2026 
 
 
 
 
11. 
Relationships 
have 
been 
satisfying 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
12. 
My religion has 
been a source of 
strength/comfort 
to me 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
13. 
I consider myself 
to 
have 
been 
religious 
or 
spiritual 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
14. 
I 
have 
felt 
hopeless 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
15. 
I have felt sad 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
16. 
I have enjoyed 
the beauty of my 
surroundings 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
The following statements are about emotional intimacy (for example, sharing deep, private thoughts; 
feeling connected). Please think about your experiences with or how you have felt about emotional 
intimacy in the past week, and use the scales provided below to respond. 
 
 
 
Strongly 
Disagree 
 
 
 
 
 
 
 
 
 
Strongly 
Agree 
17. 
My desire 
for 
emotional 
intimacy 
has been 
strong 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
18. 
I have 
shared 
emotional 
intimacy 
with 
others  
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
The following statements are about physical intimacy (for example, touching, hugging, kissing). Please 
think about your experiences with or how you have felt about physical intimacy in the past week, and 
use the scales provided below to respond. 
 
 
 
Strongly 
Disagree 
 
 
 
 
 
 
 
 
 
Strongly 
Agree 

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February 17, 2026 
 
 
 
 
19. 
My 
desire 
for 
physical 
intimacy 
has 
been 
strong 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
20. 
I 
have 
shared 
physical 
intimacy 
with 
others 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 

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February 17, 2026 
 
 
 
 
Appendix D - Patient Global Impression of Improvement (PGI-I) Scale 
 
 
Participant ID# ____________________ 
 
Date: 
 
 
1. What best describes how your anxiety is now, compared to how it was before you started the VR guided 
breathing sessions?  
 
o Very much better 
o Much better 
o A little better 
o No change 
o A little worse 
o Much worse 
o Very much worse 
 
2. What best describes how your quality of life is now, compared to how it was before you started the VR 
guided breathing sessions?  
 
o Very much better 
o Much better 
o A little better 
o No change 
o A little worse 
o Much worse 
o Very much worse 
 
 

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Appendix E – Study Budget: 
Item 
Description 
Itemized Total 
OPERATING EXPENSES: 
 
 
 
Salaries: 
Principal and Co-Investigators 
 
$40,000 
 
 
Lead Site Research Manager 
$20,000 
 
Lead Site Study Coordinator 
$20,000  
 
Participating site local research 
coordinators 
 
$7,500 per participating study site (4 
sites total) per year (2 years) = 
$60,000 
CAPITAL EXPENSES: 
 
 
Equipment: 
 
Virtual Reality Oculus Meta 
Quest 3 Devices (2 devices per 
site = 10 total) 
$8000 
 
VR Attachments 
$500 
 
Tripp Application Yearly 
Subscription (for 2 years) 
$1,200 
 
Tablets (1 per VR device = 10 
tablets total) 
$4000 
 
Grand Total 
$153,700 

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February 17, 2026 
 
 
 
 
Funded awards: 
Name of Award 
Amount Awarded 
Budgeted Items 
SCCR (lead site) Canadian 
Neuromuscular Disease 
Registry Grant 
$60,000 
$7,500 per site (4 sites total) for 2 years 
to be used by local researchers to 
complete device training with 
participants, data collection and data 
transfer to the host site = $60,000-
$7,500 (see Chesley Award below) 
= $52,500  
 
In-Kind Contribution 
$48,000 
Principal and Co-Investigators time 
($40,000), Clinical Research Manager 
Time ($20,000) 
$10,000 per year for a lead site study 
coordinator for 2 years ($20,000) 
Data Sharing Agreements prepared by 
Horizon Health Budgets and Contracts 
Manager ($5,000) 
Waiver of REB fees at Host Site for 
Investigator-Led Trial ($3,000) 
Chesley Family Research 
Award 
$25,000 
Study equipment ($12,500) 
Salary of local researcher at 1 site for 1 
year ($7,500) 
Knowledge Translation - Open Access 
Publication and National/International 
Conference Dissemination = $5,000 
 
Rehabilitation Program 
Endowment Grant (QEII 
Foundation) 
 
$1,309.33 
One set of equipment costs (VR, 
attachments, tablet, app) for the Nova 
Scotia study site received by one of the 
co-investigators