Development and Pilot Testing of Virtually Simulated Intervention for Patients Having Stuttering
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Severity of Stuttering
研究概览
简要总结
This study aims to develop and pilot test a culturally appropriate virtual reality (VR)-based speech restructuring intervention for individuals with stuttering in Pakistan. During the development phase, five VR scenarios representing common real-life communication situations will be designed using a structured development process, including scenario generation, storyboarding, live-action role plays, expert review, and standard operating procedure (SOP) development. The scenarios will incorporate graded difficulty levels, speech restructuring practice, relaxation exercises, interactive avatars, and realistic audiovisual elements.
Following development, a pilot study will be conducted with 10 participants with stuttering aged 13-35 years to evaluate the feasibility, usability, and preliminary effectiveness of the intervention. Participants will receive 16 therapy sessions using the VR scenarios, with assessments conducted before and after the intervention to measure changes in stuttering severity, speech fluency, communication attitudes, associated motor behaviors, physiological factors, and sense of presence within the virtual environment. Findings from the pilot study will be used to refine the intervention before conducting a larger clinical trial.
详细描述
This study consists of the development and pilot testing of a culturally adapted virtual reality (VR)-based speech restructuring intervention for individuals with stuttering in Pakistan. The overall objective is to design an immersive intervention that simulates everyday speaking situations while providing opportunities to practice speech restructuring techniques in a controlled and progressive virtual environment.
During the development phase, five VR scenarios will be created based on commonly encountered communication situations within the Pakistani cultural context. The scenarios will be developed with increasing levels of communication difficulty and will exclude culturally inappropriate or violent content. The development process will involve literature review, observation of real-life communication situations, brainstorming and ideation, storyboard development, live-action role plays, and conversion into immersive 3D virtual environments. A neutral adaptation environment will be included to familiarize participants with the VR system before exposure to therapeutic scenarios.
The VR intervention will be delivered using the Oculus Quest 2 head-mounted display. Each scenario will incorporate realistic environmental sounds, interactive avatars of different ages and genders, adjustable audience size and positioning, emotional expressions, varying question types, distractors, time-limited speaking tasks, relaxation exercises, and opportunities to practice speech restructuring techniques. Standard operating procedures (SOPs) will be developed to ensure standardized setup, equipment handling, participant safety, and intervention delivery. The content validity of the developed scenarios will be evaluated by six experts with at least two years of relevant professional experience using the Content Validity Index (CVI), and modifications will be made based on expert feedback.
Following development, a single-group pilot study will be conducted at Pakistan Railway Hospital to evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention. Ten bilingual participants aged 13-35 years with mild to severe stuttering will be recruited according to predefined eligibility criteria. Individuals with additional communication disorders, neurological disorders, intellectual disabilities, or significant psychological conditions will be excluded.
Participants will undergo baseline assessment followed by 16 intervention sessions conducted three times per week, with each session lasting approximately 25 minutes. The intervention will begin with orientation and training in speech restructuring techniques, followed by progressive practice within five VR communication scenarios: lecture hall, grocery store, restaurant, telephone conversation, and job interview. The final sessions will focus on practicing all scenarios and facilitating the transfer of learned skills to real-life communication environments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 35 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants having stuttering of any level will be included.
- •Participants having any primary behaviors like blocking, prolongations, Repetitions will be included.
- •Participants exhibiting any facial grimaces, body movements or muscular tensions will be included.
- •Age range 13-35 years (35)
- •Both Genders
- •Participants having stuttering severity from mild to severe
- •Bilingual population having at-least matriculation qualification
排除标准
- •Participants who have other communication problems with stuttering
- •Participants who have any associated medical condition like stroke, head trauma, or any other brain injury will also be excluded
- •Participants who had psychological problems, like depression and anxiety will be excluded from study.
- •Participants who had any intellectual or cognitive disability will be excluded from study.
研究组 & 干预措施
Virtually Simulated Intervention
Participants receive the virtually simulated intervention developed for the management of stuttering. The pilot study evaluates the feasibility and preliminary implementation of the intervention.
干预措施: Virtually Simulated Intervention (Other)
结局指标
主要结局
Severity of Stuttering
时间窗: Baseline and approximately 6 weeks (post-test, immediately after completion of the 16-session intervention)
Change from baseline in percentage of syllables stuttered will be assessed to determine changes in speech fluency following the intervention. Speech samples consisting of 200 syllables will be analyzed. The percentage of syllables stuttered will be calculated by dividing the number of syllables containing stuttering events by the total number of syllables produced and multiplying by 100. A decrease in the percentage of syllables stuttered indicates an improvement in speech fluency.
次要结局
- Overall Assessment of Speaker's Experience of Stuttering(Baseline and approximately 6 weeks])
