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

Overview

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.

Full Title of Study: “Clinical Implementation, Feasibility, & Validation of the Virtual Reality Delivered GlenxRose Speech-Language Therapies to Improve Patient Adherence and Treatment Outcomes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 1, 2024

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.
  • No Intervention: Standard Clinical Care
    • Participants will receive routine clinical care provided by speech-language pathologists.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alberta
  • Collaborator
    • Alberta Health services
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Adriana Rios Rincon, PhD, R.OT, Principal Investigator, University of Alberta
    • Antonio Miguel Cruz, DrSc, Study Chair, University of Alberta
    • James Raso, MASc, Study Chair, Glenrose Rehabilitation Hospital, Alberta Health Services
  • Overall Contact(s)
    • Adriana Rios Rincon, PhD, R.OT, 780.492.5150, aros@ualberta.ca

References

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.

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.

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