- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05695131
Clinical Feasibility & Validation of the Virtual Reality GlenxRose Speech-Language Therapies
Clinical Implementation, Feasibility, & Validation of the Virtual Reality Delivered GlenxRose Speech-Language Therapies to Improve Patient Adherence and Treatment Outcomes
Factors related to successful rehabilitation are often directly related to adherence; for instance, dosage, frequency, and intensity can burden the patient regarding time and motivational factors. Furthermore, surrounding salience, patients may lose interest or find an intervention boring after a few sessions. It is well documented that nonadherence not only impacts rehabilitation for the patient but can also further prolong treatment, and increase hospital and clinician costs, in addition to a higher prevalence of future comorbidities. Therefore, strategies that improve patient adherence can significantly help optimize patient care and treatment outcomes.
One avenue to increase patient adherence is through the gamification of rehabilitation therapies using virtual reality (VR). Gamification of rehabilitation therapy can make mass practice required in rehabilitation therapies seemingly fun and more personally engaging for the patient. Additionally, the immersive experience achieved through VR can further promote salience and be customizable to individual patient requirements. As VR systems are now highly portable and relatively simple to utilize, they can provide an excellent opportunity to continue rehabilitation practice on the home front. Overall, the VR gamification of rehabilitation may increase adherence by shifting patients' perspectives of therapy as tedious, boring, or a hassle, to a fun and engaging game that ultimately helps their recovery processes.
The GlenXRose VR-delivered speech-language therapies (Cognitive Projections Lab, University of Alberta) have been developed and piloted in collaboration with the Glenrose Rehabilitation Hospital with the overall goal of increasing patient adherence, treatment outcomes, and satisfaction with vocal therapy. The proposed studies are to investigate the feasibility of implementing this technology in routine clinical care (specific to voice disorders), obtaining clinician feedback, examining associated financial costs, and continuing to examine the effect of the GlenXRose VR speech-language therapies on patient adherence and clinical outcomes, compared to traditional clinical care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nonadherence to Speech-Language rehabilitation can result in suboptimal vocal recovery or compensation methods while impacting the quality of life and further burdening the healthcare system. In addition to traditional face-to-face voice therapy, many patients are further given daily voice exercises to practice at home. It is estimated that 38-74% of patients are nonadherent to voice therapies (Ebersole et al., 2018); with such a large prevalence, opportunities to prevent and mitigate nonadherence to voice therapy can significantly promote clinical/functional outcomes. In a recent meta-analysis, it is reported that methods increasing adherence to speech-language rehabilitation further promote home practice (Bartlett et al., 2022). One identified method of promise includes technological approaches (Bartlett et al., 2022) such as the GlenXRose VR Speech-Language therapies (VR-SLP).
Purpose & Objective: The GlenXRose VR-SLP program, developed by the Cognitive Projections lab at the University of Alberta in collaboration with the Glenrose Rehabilitation Hospital, provides patients with gamified vocal exercises, therapies, and education delivered through immersive virtual reality. With the degree of VR portability, patients will be able to take the equipment home to facilitate at-home vocal practice.
The objective of these studies is to examine the feasibility of implementing the previously developed GlenXRose VR Speech Language therapies (VR-SLP) to routine clinical care delivered by Speech-Language Pathologists to patients with vocal cord disorders. The variables of patient adherence to treatment as well as preliminary effects on vocal measurements (Voice Handicapped Index - 10; Acoustic Analysis of Voice) will be explored.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adriana Rios Rincon, PhD, R.OT
- Phone Number: 780.492.5150
- Email: aros@ualberta.ca
Study Contact Backup
- Name: Mathieu Figeys, PhD, RN
- Phone Number: 780.735.6296
- Email: figeys@ualberta.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T5G 0B7
- Recruiting
- Glenrose Rehabilitation Hospital
-
Contact:
- Mathieu Figeys, PhD, RN
- Phone Number: 780.735.6296
- Email: figeys@ualberta.ca
-
Contact:
- James Raso, MASc
- Phone Number: 7807357964
- Email: james.raso@albertahealthservices.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults receiving speech-language therapy at the Glenrose Rehabilitation Hospital (Edmonton, AB, Canada; Alberta Health Services)
- Presence of a speech disorder
- Proficiency in English
- Able to provide signed informed consent to participate in the study
Exclusion Criteria:
- Severe cognitive impairments and/or behavioural impairments
- Communication disorders that impact comprehension of verbal commands and understanding of scale used in the study
- Previous history of neurological or psychiatric disorder
- Substance use disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Delivered Therapy + Standard Clinical Care
The GlenXRose virtual reality therapies will be delivered to participants using a head-mounted device to allow vocal therapy and practice.
Participants will also receive routine clinical care provided by speech-language pathologists.
|
Speech therapies for vocal cord disorders have been developed for virtual reality implementation.
These include various games to interact with in a virtual environment while conducting rehabilitation therapy, in addition to educational visualizations
|
|
No Intervention: Standard Clinical Care
Participants will receive routine clinical care provided by speech-language pathologists.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Frequency and Treatment Adherence Rates
Time Frame: Up to 12 Weeks
|
Reported Frequency of Rehabilitation Therapy
|
Up to 12 Weeks
|
|
Change in Generalization
Time Frame: Up to 12 Weeks
|
Self-reported time using voice production techniques
|
Up to 12 Weeks
|
|
Change in Compliance Rate
Time Frame: Up to 12 Weeks
|
Self-reported time (using a visual analog scale)
|
Up to 12 Weeks
|
|
Change in Voice Handicap Index - 10
Time Frame: Up to 12 Weeks
|
Quantification of participant reported perspectives of voice impairment(s)
|
Up to 12 Weeks
|
|
Change in Acoustic Analysis of Voice
Time Frame: Up to 12 Weeks
|
Conducted by Registered Speech-Language Pathologists (as part of standard care)
|
Up to 12 Weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Adriana Rios Rincon, PhD, R.OT, University of Alberta
- Study Chair: Antonio Miguel Cruz, DrSc, University of Alberta
- Study Chair: James Raso, MASc, Glenrose Rehabilitation Hospital, Alberta Health Services
Publications and helpful links
General Publications
- Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
- Rosen CA, Lee AS, Osborne J, Zullo T, Murry T. Development and validation of the voice handicap index-10. Laryngoscope. 2004 Sep;114(9):1549-56. doi: 10.1097/00005537-200409000-00009.
- Bartlett RS, Carpenter AM, Chapman LK. A Systematic Review of Adherence Strategies for Adult Populations in Speech-Language Pathology Treatment. Am J Speech Lang Pathol. 2022 May 10;31(3):1501-1516. doi: 10.1044/2022_AJSLP-21-00255. Epub 2022 Mar 23.
- Ebersole B, Soni RS, Moran K, Lango M, Devarajan K, Jamal N. The Role of Occupational Voice Demand and Patient-Rated Impairment in Predicting Voice Therapy Adherence. J Voice. 2018 May;32(3):325-331. doi: 10.1016/j.jvoice.2017.06.002. Epub 2017 Jul 11.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Respiratory Tract Diseases
- Neurobehavioral Manifestations
- Respiration Disorders
- Otorhinolaryngologic Diseases
- Laryngeal Diseases
- Communication Disorders
- Language Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Communication
- Verbal Behavior
- Speech Disorders
- Vocal Cord Dysfunction
- Speech
Other Study ID Numbers
- Pro00126403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Speech Disorders
-
Riphah International UniversitySADA NGOCompletedChildren | Cochlear Implant | Speech Sound DisorderPakistan
-
Altec Inc.CompletedSpeech Disorders | Speech Perception | Rehabilitation of Speech and Language Disorders | Speech, Alaryngeal | Communication Aids for Disabled | Speech IntelligibilityUnited States
-
Prof. Dr. Cemil Tascıoglu Education and Research...CompletedHead and Neck Cancer | Speech Disorders | Speech Intelligibility | Speech | Speech DysfunctionTurkey
-
University of PittsburghDuquesne UniversityRecruiting
-
New York UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD); Syracuse... and other collaboratorsCompletedSpeech Sound DisorderUnited States
-
Pusan National University Yangsan HospitalNot yet recruitingPatients With Speech Disorders
-
University of Central FloridaNational Institute on Deafness and Other Communication Disorders (NIDCD); University...CompletedDown Syndrome | Speech Sound Disorder | Speech Disorders in Children | Speech Intelligibility | Speech and Language DisorderUnited States
-
Universidade Federal de Santa MariaCompleted
-
Boston University Charles River CampusThe University of Hong Kong; Tufts University; University of Arizona; University... and other collaboratorsCompletedPublic Speaking | Speech AnxietyUnited States, Australia, Netherlands, China, Germany
-
Yale UniversityCompleted
Clinical Trials on GlenXRose Virtual Reality Speech Therapies
-
University of AlbertaAlberta Health services; MitacsNot yet recruitingStroke | Traumatic Brain Injury | Acquired Brain InjuryCanada
-
Taipei Veterans General Hospital, TaiwanRecruiting
-
Abant Izzet Baysal UniversityCompleted
-
IRCCS Centro Neurolesi Bonino PulejoEnrolling by invitationLanguage Development DisordersItaly
-
University Hospital, ToulouseLigue contre le cancer, France; Association Laurette FugainNot yet recruitingAcute Myeloid LeukemiaFrance
-
Istinye UniversityCompletedHealth-Related BehaviorTurkey (Türkiye)
-
University of SevilleNot yet recruiting
-
Icahn School of Medicine at Mount SinaiEnrolling by invitation
-
Imperial College LondonRecruitingHearing Loss | Aminoglycoside Toxicity | Video Games | Aminoglycoside-Induced Hearing LossUnited Kingdom
-
Institut National de la Santé Et de la Recherche...RecruitingSchizophrenia | Bipolar DisorderFrance