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临床试验/NCT05695131
NCT05695131招募中不适用

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

University of Alberta2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Change in Generalization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Standard Clinical Care

No Intervention

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

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.

干预措施: GlenXRose Virtual Reality Speech Therapies (Device)

结局指标

主要结局

Change in Generalization

时间窗: Up to 12 Weeks

Self-reported time using voice production techniques

Change in Frequency and Treatment Adherence Rates

时间窗: Up to 12 Weeks

Reported Frequency of Rehabilitation Therapy

Change in Compliance Rate

时间窗: Up to 12 Weeks

Self-reported time (using a visual analog scale)

Change in Voice Handicap Index - 10

时间窗: Up to 12 Weeks

Quantification of participant reported perspectives of voice impairment(s)

Change in Acoustic Analysis of Voice

时间窗: Up to 12 Weeks

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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