NCT07863778

Brief Summary

Speech sound disorders can affect intelligibility, learning, participation, and communication in children. This completed randomized controlled trial evaluated AI-Integrated Virtual Reality Speech Therapy (AI-IVR-ST) against conventional speech therapy in children aged 5 to 12 years with articulation and/or phonological disorders. Sixty-four children were randomized equally to two groups and received treatment three times per week for 12 weeks. The principal efficacy outcome was Percentage of Consonants Correct (PCC). Additional outcomes included GFTA-3, PPVT-4, therapy engagement and adherence, FACES III, and ASHA NOMS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 7, 2026

Completed
Last Updated

October 7, 2026

Status Verified

October 1, 2026

Enrollment Period

3 months

First QC Date

September 22, 2026

Last Update Submit

October 3, 2026

Conditions

Keywords

Artificial intelligenceVirtual realityNon-immersive virtual realitySpeech therapyPediatric rehabilitationPercentage of Consonants CorrectAutomatic speech recognitionSpeech BlubsKinectEngagementAdherence

Outcome Measures

Primary Outcomes (1)

  • Percentage of Consonants Correct (PCC)

    PCC is the percentage of intended consonants produced correctly in a defined speech sample, calculated as the number of correctly produced consonants divided by total intended consonants and multiplied by 100. Higher percentages indicate greater phonological accuracy.

    Baseline, Week 6, and Week 12

Secondary Outcomes (6)

  • Goldman-Fristoe Test of Articulation, Third Edition (GFTA-3) Standard Score

    Baseline, Week 6, and Week 12

  • Peabody Picture Vocabulary Test, Fourth Edition (PPVT-4) Standard Score

    Baseline, Week 6, and Week 12

  • Therapy Engagement Composite Score Assessed Using the Study-Specific Therapist-Rated Engagement Checklist

    Baseline, Week 6, and Week 12

  • Therapy Adherence

    Weekly during the 12-week intervention; summary at Week 6 and Week 12

  • FACES III Total Score

    Baseline and Week 12

  • +1 more secondary outcomes

Study Arms (2)

Experimental: AI-Integrated Virtual Reality Speech Therapy

EXPERIMENTAL

Participants received AI-IVR-ST three times per week for 12 weeks. Each 45- to 50-minute clinic session included Kinect-based non-immersive virtual reality, AI-assisted Speech Blubs practice, and therapist-guided speech generalization. Caregiver-supervised Speech Blubs home practice was prescribed for approximately 15 to 20 minutes per day, five days per week.

Other: AI-Integrated Virtual Reality Speech Therapy (AI-IVR-ST)

Active Comparator: Conventional Speech Therapy

ACTIVE COMPARATOR

Participants received conventional face-to-face speech therapy from a speech-language pathologist for approximately 45 to 50 minutes, three times per week, for 12 weeks, together with a printed home exercise programme.

Other: Conventional Speech Therapy

Interventions

The multicomponent programme combined approximately 15 minutes of Kinect-based non-immersive virtual reality, 15 to 20 minutes of AI-assisted Speech Blubs practice, and 10 to 15 minutes of therapist-guided speech generalization. The intervention progressed from isolated sounds and syllables to words, phrases, sentences, conversation, and spontaneous communication. Caregivers supervised home Speech Blubs practice for approximately 15 to 20 minutes per day on five days per week.

Also known as: AI-IVR-ST
Experimental: AI-Integrated Virtual Reality Speech Therapy

Conventional face-to-face speech therapy included articulation therapy, phonological intervention, auditory discrimination, minimal-pair therapy, cycles-based elements, mirror therapy, picture and object naming, word-to-sentence practice, storytelling, conversational speech, and a printed home exercise programme. Sessions lasted approximately 45 to 50 minutes, three times per week for 12 weeks.

Active Comparator: Conventional Speech Therapy

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 5 to 12 years.
  • Confirmed articulation disorder and/or phonological disorder diagnosed by a qualified speech-language pathologist.
  • Ability to follow simple verbal instructions.
  • Normal or corrected-to-normal vision and hearing.
  • Written caregiver consent and age-appropriate child assent where applicable.
  • Availability to participate throughout the 12-week intervention period.

You may not qualify if:

  • Autism spectrum disorder.
  • Cerebral palsy.
  • Intellectual disability.
  • Hearing impairment incompatible with study assessment.
  • Cleft lip and/or palate.
  • Neurological disorders affecting speech.
  • Severe behavioural disorders that prevented participation.
  • Intensive speech therapy during the preceding three months.
  • Medical conditions that prevented safe participation in the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chaudhary Muhammad Akram Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

Comprehensive Rehabilitation Centre, Superior University Lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Speech Sound DisorderArticulation DisordersCommunication Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersSpeech DisordersLanguage DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fariha Ambreen Chaudhry

    Superior University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessment was performed by trained speech-language pathologists who were kept unaware of treatment allocation. Participants, caregivers, and treating therapists could not be blinded because of the visible nature of the interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomized in a 1:1 ratio to AI-IVR-ST or conventional speech therapy, with 32 participants per group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2026

First Posted

October 7, 2026

Study Start

July 1, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

October 7, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations