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Not Yet Recruiting NCT07833969

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

Conditions: Stuttering

Sex: All
Ages: 13 Years – 35 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Riphah International University

Location: National Institute of Rehabilitation Medicine Islamabad

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 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

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07833969). StuddyBuddy aggregates publicly available trial information.