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

NCT05695131 | Recruiting

• 1 other identifier: Pro00126403
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vocal Cord Dysfunction; Speech Disorders

Keywords

Vocal; Speech; Speech-Language Pathology; Virtual Reality; VR

Outcome Measures

Primary Outcomes (5)

• Change in Frequency and Treatment Adherence Rates

  Reported Frequency of Rehabilitation Therapy

  Up to 12 Weeks

• Change in Generalization

  Self-reported time using voice production techniques

  Up to 12 Weeks

• Change in Compliance Rate

  Self-reported time (using a visual analog scale)

  Up to 12 Weeks

• Change in Voice Handicap Index - 10

  Quantification of participant reported perspectives of voice impairment(s)

  Up to 12 Weeks

• Change in Acoustic Analysis of Voice

  Conducted by Registered Speech-Language Pathologists (as part of standard care)

  Up to 12 Weeks

Study Arms (2)

Virtual Reality Delivered Therapy + Standard Clinical Care

EXPERIMENTAL

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.

Device: GlenXRose Virtual Reality Speech Therapies

Standard Clinical Care

NO INTERVENTION

Participants will receive routine clinical care provided by speech-language pathologists.

Interventions

GlenXRose Virtual Reality Speech Therapies DEVICE

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

Virtual Reality Delivered Therapy + Standard Clinical Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

RECRUITING

Related Publications (4)

• 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.

  PMID: 15475780 BACKGROUND

• 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.

  PMID: 35320678 BACKGROUND

• 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.

  PMID: 28709763 BACKGROUND

• 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.

  PMID: 27965879 BACKGROUND

MeSH Terms

Conditions

Vocal Cord Dysfunction; Speech Disorders; Speech

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior

Study Officials

• Adriana Rios Rincon, PhD, R.OT

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Antonio Miguel Cruz, DrSc

  University of Alberta

  STUDY CHAIR

• James Raso, MASc

  Glenrose Rehabilitation Hospital, Alberta Health Services

  STUDY CHAIR

Central Study Contacts

Adriana Rios Rincon, PhD, R.OT

CONTACT

780.492.5150; aros@ualberta.ca

Mathieu Figeys, PhD, RN

CONTACT

780.735.6296; figeys@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be masked to group allocation (VR-delivered therapy + standard care, or traditional standard care alone). Participants will be asked by a research assistant not to reveal details of the group allocation prior to assessments.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study 1: Single-Subject Experimental Design Studies will be Implemented (A-B Design) Study 2: Feasibility randomized controlled trial (control and intervention groups)

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 23, 2023
• Study Start: September 20, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)