StutteringNCT07833969
Development and Pilot Testing of Virtually Simulated Intervention for Patients Having Stuttering
A study testing Virtually Simulated Intervention in people with Stuttering, run by Riphah International University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 35 years
- Conditions the study is for
- Stuttering
- What is being tested?
- Virtually Simulated Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
National Institute of Rehabilitation Medicine
Islamabad, 4600
Tehreem Ijaz, PhD Scholar, +923345307011, tehreem.ijaz@riphah.edu.pk
tehreem.ijaz90@gmail.com
About this study
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.
Read the 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.
- Conditions
- Stuttering
- Being tested
- Virtually Simulated Intervention
- Keywords
- Stuttering, Virtually Simulated Intervention, Adolesence
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtually Simulated InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtually Simulated Intervention | Experimental | Participants receive the virtually simulated intervention developed for the management of stuttering. The pilot study evaluates the feasibility and preliminary implementation of the intervention. Receives: Other: Virtually Simulated Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Stuttering
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.
Measured: Baseline and approximately 6 weeks (post-test, immediately after completion of the 16-session intervention)
Secondary outcomes (1)
Overall Assessment of Speaker's Experience of Stuttering
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.
Measured: Baseline and approximately 6 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StutteringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tehreem Ijaz, PhD Scholar, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833969
- Sponsor's protocol ID
- REC/011100
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of Virtually Simulated Intervention for Patients Having Stuttering
- ClinicalTrials.gov ID
- NCT07833969
- Acronym / sponsor ID
- REC/011100
- Conditions
- Stuttering
- Keywords
- Stuttering, Virtually Simulated Intervention, Adolesence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtually Simulated Intervention | Experimental | Other: Virtually Simulated InterventionParticipants receive the virtually simulated intervention developed for the management of stuttering. The pilot study evaluates the feasibility and preliminary implementation of the intervention. |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtually Simulated InterventionA 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. | Other | Virtually Simulated Intervention |
Primary outcome
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.
1 secondary outcome
Overall Assessment of Speaker's Experience of Stuttering
Time frame: Baseline and approximately 6 weeks]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Stuttering
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Transcranial Alternating Current Stimulation (tACS) in Stuttering
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tehreem Ijaz, PhD Scholar principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtually Simulated Intervention in people with Stuttering, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Humaira Shamim Kiyani, PhD (+923005471389, humaira.shamim@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Stuttering (time frame: Baseline and approximately 6 weeks (post-test, immediately after completion of the 16-session intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.