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

21 de septiembre de 2026 actualizado por: Riphah International University

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

10

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Islamabad, Pakistán, 4600
        • National Institute of Rehabilitation Medicine
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Tehreem Ijaz

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

13 años a 35 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Severity of Stuttering
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Assessment of Speaker's Experience of Stuttering
Periodo de tiempo: 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]

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Tehreem Ijaz, PhD Scholar, Riphah International University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

10 de septiembre de 2026

Finalización primaria (Estimado)

15 de octubre de 2026

Finalización del estudio (Estimado)

15 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

5 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de septiembre de 2026

Publicado por primera vez (Actual)

22 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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