Clinical Feasibility & Validation of the Virtual Reality GlenxRose Speech-Language Therapies

Speech Disorders Clinical Trial

Official title:

Clinical Implementation, Feasibility, & Validation of the Virtual Reality Delivered GlenxRose Speech-Language Therapies to Improve Patient Adherence and Treatment Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05695131
• Other study ID #: Pro00126403
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: University of Alberta
• Contact: Adriana Rios Rincon, PhD, R.OT
• Phone: 780.492.5150
• Email: aros[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Speech Disorders
• Vocal Cord Dysfunction

Intervention

Device:
• GlenXRose Virtual Reality Speech Therapies
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

Locations

Country	Name	City	State
Canada	Glenrose Rehabilitation Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Health services

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Frequency and Treatment Adherence Rates	Reported Frequency of Rehabilitation Therapy	Up to 12 Weeks
Primary	Change in Generalization	Self-reported time using voice production techniques	Up to 12 Weeks
Primary	Change in Compliance Rate	Self-reported time (using a visual analog scale)	Up to 12 Weeks
Primary	Change in Voice Handicap Index - 10	Quantification of participant reported perspectives of voice impairment(s)	Up to 12 Weeks
Primary	Change in Acoustic Analysis of Voice	Conducted by Registered Speech-Language Pathologists (as part of standard care)	Up to 12 Weeks

External Links

•   Cognitive Projections Laboratory, University of Alberta