Development and Pilot Testing of Virtually Simulated Intervention for Patients Having Stuttering

ConditionStuttering
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-35
SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Virtually Simulated Intervention

    Other 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Virtually Simulated InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
Baseline and approximately 6 weeks]

Other outcomes

Sponsors and contacts

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