Effectiveness 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 randomized controlled trial aims to evaluate the effectiveness of a culturally appropriate virtual reality (VR)-based speech restructuring intervention for individuals with stuttering in Pakistan. The intervention consists of five VR scenarios representing common real-life communication situations, incorporating graded difficulty levels, speech restructuring techniques, relaxation exercises, interactive avatars, and realistic audiovisual elements.

Eligible participants with stuttering will be randomly allocated to an experimental group receiving the VR-based speech restructuring intervention or a control group. Participants in the experimental group will receive 16 therapy sessions using the developed VR scenarios. Assessments will be conducted at baseline, during the intervention, and after completion of the intervention to evaluate changes in stuttering severity, speech fluency, communication attitudes, associated motor behaviors, physiological factors, and sense of presence within the virtual environment.

The study will determine whether the VR-based intervention is effective in improving speech fluency and reducing the severity and associated features of stuttering compared with the control condition. The findings will provide evidence regarding the effectiveness of VR-based speech restructuring as a culturally appropriate intervention for individuals with stuttering.

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

Parallel

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.
Traditional Speech Therapy
Other intervention
Participants in the control group will receive traditional speech intervention for stuttering without the use of virtual reality. The intervention will involve therapist-guided practice of speech restructuring techniques in clinics by using scenario-based solutions. Participants will receive intervention sessions according to the same treatment schedule and duration as the experimental group. The intervention will focus on improving speech fluency and reducing the severity of stuttering through structured practice and application of speech restructuring techniques in everyday communication situations.

Treatment groups

44 Participants

are divided into 2 treatment groups

Group A: Virtually Simulated InterventionExperimental treatment 1 intervention

Group B: Fluency Shaping TechniquesActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Riphah International University

Lead sponsor

Source ClinicalTrials.gov

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