Development and Pilot Testing of Virtually Simulated Intervention for Patients Having Stuttering
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Outcome measures will be collected before and after the intervention using standardized assessment tools. These will include real-time analysis of speech fluency, dysfluency index, assessment of physiological factors associated with stuttering, the Modified S Scale for communication attitudes and emotions, assessment of associated motor behaviors, and the Presence Questionnaire to evaluate participants' experience within the virtual environment.
Data from the pilot study will be analyzed using SPSS Version 20. Descriptive statistics will summarize participant characteristics and feasibility outcomes. Changes between baseline and post-intervention assessments will be analyzed using either the paired-samples t-test or the Wilcoxon signed-rank test, depending on the distribution of the data. Feedback obtained during participant debriefing sessions will be used to further refine the VR intervention protocol before proceeding to a larger-scale clinical trial.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Humaira Shamim Kiyani, PhD
- Phone Number: +923005471389
- Email: humaira.shamim@riphah.edu.pk
Study Locations
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Islamabad, Pakistan, 4600
- National Institute of Rehabilitation Medicine
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Contact:
- Tehreem Ijaz, PhD Scholar
- Phone Number: +923345307011
- Email: tehreem.ijaz@riphah.edu.pk
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Contact:
- Email: tehreem.ijaz90@gmail.com
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Principal Investigator:
- Tehreem Ijaz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
A standardized virtually simulated intervention comprising 2D video-based communication scenarios delivered using a Meta Quest 2 virtual reality headset. Participants viewed and controlled the playback of the simulated scenarios during therapy sessions according to the study protocol. Participants will receive intervention 3 days/week for 25 minutes. A total of 16 sessions will be conducted. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of Stuttering
Time Frame: 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. |
Baseline and approximately 6 weeks (post-test, immediately after completion of the 16-session intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Assessment of Speaker's Experience of Stuttering
Time Frame: Baseline and approximately 6 weeks]
|
Change from baseline in the overall impact of stuttering will be assessed using the Overall Assessment of the Speaker's Experience of Stuttering (OASES). The OASES assesses the speaker's experience of stuttering across multiple domains, including general information about stuttering, reactions to stuttering, communication in daily situations, and quality of life. The instrument provides an overall impact score, with higher scores indicating a greater negative impact of stuttering on the individual's life. Changes in the overall impact score from baseline to post-test will be evaluated to determine the effectiveness of the intervention. |
Baseline and approximately 6 weeks]
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tehreem Ijaz, PhD Scholar, Riphah International University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/011100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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