Effectiveness of Virtually Simulated Intervention for Patients Having Stuttering

NCT07844278 | Not Yet Recruiting

• 1 other identifier: Ref#Riphah/RCRS/REC/011100
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stuttering

Keywords

Stuttering; Virtually simulated intervention; Adolesence and Adults

Outcome Measures

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.

  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

  Baseline and approximately 6 weeks

Study Arms (2)

Virtually Simulated Intervention

EXPERIMENTAL

Participants receive the virtually simulated intervention developed for the management of stuttering. The study will evaluate the effectiveness of this intervention on the targeted population.

Other: Virtually Simulated Intervention

Fluency Shaping Techniques

ACTIVE COMPARATOR

Participants will receive the intervention as per described intervention protocol.

Other: Traditional Speech Therapy

Interventions

Virtually Simulated Intervention OTHER

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.

Virtually Simulated Intervention

Traditional Speech Therapy OTHER

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.

Fluency Shaping Techniques

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

National Institute of Rehabilitation Medicine

Islamabad, 4600, Pakistan

Location

Related Publications (7)

• SB. B. Virtual reality augmentation for functional assessment and treatment of stuttering. Topics in Language Disorders. 2007 Jul 1; 27(3): 254-71. JS. Y. Real-time analysis of speech fluency: Procedures and reliability training. American Journal of Speech-Language Pathology. 1998 May; 7(2): 25-37.

  BACKGROUND

• Brundage SB, Brinton JM, Hancock AB. Utility of virtual reality environments to examine physiological reactivity and subjective distress in adults who stutter. J Fluency Disord. 2016 Dec;50:85-95. doi: 10.1016/j.jfludis.2016.10.001. Epub 2016 Oct 5.

  PMID: 27720393 BACKGROUND

• Vaezipour A, Aldridge D, Koenig S, Theodoros D, Russell T. "It's really exciting to think where it could go": a mixed-method investigation of clinician acceptance, barriers and enablers of virtual reality technology in communication rehabilitation. Disabil Rehabil. 2022 Jul;44(15):3946-3958. doi: 10.1080/09638288.2021.1895333. Epub 2021 Mar 14.

  PMID: 33715566 BACKGROUND

• Brundage SB, Graap K, Gibbons KF, Ferrer M, Brooks J. Frequency of stuttering during challenging and supportive virtual reality job interviews. J Fluency Disord. 2006;31(4):325-39. doi: 10.1016/j.jfludis.2006.08.003. Epub 2006 Sep 26.

  PMID: 16999990 BACKGROUND

• Brignell A, Krahe M, Downes M, Kefalianos E, Reilly S, Morgan AT. A systematic review of interventions for adults who stutter. J Fluency Disord. 2020 Jun;64:105766. doi: 10.1016/j.jfludis.2020.105766. Epub 2020 Apr 30.

  PMID: 32438123 BACKGROUND

• Laiho A, Elovaara H, Kaisamatti K, Luhtalampi K, Talaskivi L, Pohja S, Routamo-Jaatela K, Vuorio E. Stuttering interventions for children, adolescents, and adults: a systematic review as a part of clinical guidelines. J Commun Disord. 2022 Sep-Oct;99:106242. doi: 10.1016/j.jcomdis.2022.106242. Epub 2022 Jun 16.

  PMID: 35751980 BACKGROUND

• Sommer M, Waltersbacher A, Schlotmann A, Schroder H, Strzelczyk A. Prevalence and Therapy Rates for Stuttering, Cluttering, and Developmental Disorders of Speech and Language: Evaluation of German Health Insurance Data. Front Hum Neurosci. 2021 Apr 12;15:645292. doi: 10.3389/fnhum.2021.645292. eCollection 2021.

  PMID: 33912020 BACKGROUND

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tehreem Ijaz, PhD Scholar

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Humaira Shamim Dr. Humaira Shamim Kiyani, PhD Rehabilitation Sciences

CONTACT

+923005471389; humaira.shamim@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): October 25, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)