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

21 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

10

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 13 anni a 35 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Severity of Stuttering
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Assessment of Speaker's Experience of Stuttering
Lasso di tempo: 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]

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Tehreem Ijaz, PhD Scholar, Riphah International University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 settembre 2026

Completamento primario (Stimato)

15 ottobre 2026

Completamento dello studio (Stimato)

15 ottobre 2026

Date di iscrizione allo studio

Primo inviato

5 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 settembre 2026

Primo Inserito (Effettivo)

22 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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