Speech Sound DisorderNCT07863778
AI-Integrated Virtual Reality Speech Therapy in Children With Speech Sound Disorders
A study testing AI-Integrated Virtual Reality Speech Therapy (AI-IVR-ST) and Conventional Speech Therapy in people with Speech Sound Disorder and Articulation Disorder, run by Superior University at 2 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Speech Sound Disorder, Articulation Disorder, Phonological Disorder
- What is being tested?
- AI-Integrated Virtual Reality Speech Therapy (AI-IVR-ST) and Conventional Speech Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jul 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Autism spectrum disorder.
- Cerebral palsy.
- Intellectual disability.
- Hearing impairment incompatible with study assessment.
- Cleft lip and/or palate.
- Neurological disorders affecting speech.
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- Severe behavioural disorders that prevented participation.
- Intensive speech therapy during the preceding three months.
- Medical conditions that prevented safe participation in the intervention.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Chaudhary Muhammad Akram Teaching Hospital
Lahore, Punjab Province
Comprehensive Rehabilitation Centre, Superior University Lahore
Lahore, Punjab Province
About this study
Official title: AI-Integrated Virtual Reality for Interactive Speech Therapy in Children With Speech Disorders
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.
Read the detailed description
This was a two-arm, parallel-group, assessor-blinded randomized controlled trial comparing AI-Integrated Virtual Reality Speech Therapy (AI-IVR-ST) with conventional speech therapy. Participants were children aged 5 to 12 years with articulation disorder and/or phonological disorder diagnosed by a qualified speech-language pathologist. Computer-generated block randomization with variable block sizes was used and allocation was concealed using sequentially numbered opaque sealed envelopes. Each group received three 45- to 50-minute clinic sessions per week for 12 weeks. The experimental intervention combined Kinect-based non-immersive virtual reality, AI-assisted Speech Blubs practice, therapist-guided speech generalization, and caregiver-supervised home practice. The control arm received conventional face-to-face speech therapy with a printed home exercise programme. Outcomes were assessed at baseline, Week 6, and Week 12; FACES III and ASHA NOMS were assessed at baseline and Week 12.
- Being tested
- AI-Integrated Virtual Reality Speech Therapy (AI-IVR-ST), Conventional Speech Therapy
- Keywords
- Artificial intelligence, Virtual reality, Non-immersive virtual reality, Speech therapy, Pediatric rehabilitation, Percentage of Consonants Correct, Automatic speech recognition, Speech Blubs, Kinect, Engagement, Adherence
- Medical subject headings
- Speech Sound Disorder, Articulation Disorders, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Integrated Virtual Reality Speech Therapy (AI-IVR-ST)Other
Also called AI-IVR-ST
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.
Conventional Speech TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Speech Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 6, and Week 12
Secondary outcomes (6)
Goldman-Fristoe Test of Articulation, Third Edition (GFTA-3) Standard Score
Standardized measure of speech sound production. Higher standard scores indicate better articulation performance.
Measured: Baseline, Week 6, and Week 12
Peabody Picture Vocabulary Test, Fourth Edition (PPVT-4) Standard Score
Standardized measure of receptive vocabulary. Higher standard scores indicate better receptive-vocabulary performance.
Measured: Baseline, Week 6, and Week 12
Therapy Engagement Composite Score Assessed Using the Study-Specific Therapist-Rated Engagement Checklist
Therapy engagement was assessed using the Study-Specific Therapist-Rated Engagement Checklist, a structured therapist-rated measure assessing attention, task participation, responsiveness, motivation, completion of therapeutic activities, interaction with the therapist, and interaction with the virtual environment. Item ratings were combined to produce a total Therapy Engagement Composite Score ranging from 0 to 24 points, with higher scores indicating greater therapy engagement.
Measured: Baseline, Week 6, and Week 12
Therapy Adherence
Adherence was monitored using clinic attendance, home-practice completion, and an adherence composite. The planned clinic dose was three sessions per week for 12 weeks.
Measured: Weekly during the 12-week intervention; summary at Week 6 and Week 12
FACES III Total Score
Family functioning was assessed using the FACES III total score.
Measured: Baseline and Week 12
ASHA NOMS Functional Communication/Participation Score
Functional communication, activity, and participation were assessed using ASHA NOMS on the study's recorded 1-to-7 scale.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Jul 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech Sound DisorderStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to AI-IVR-ST or conventional speech therapy, with 32 participants per group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
- Investigators
- Fariha Ambreen Chaudhry, Principal investigator, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863778
- Sponsor's protocol ID
- SU91-PHRSW-F23-010
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Integrated Virtual Reality for Interactive Speech Therapy in Children With Speech Disorders
- ClinicalTrials.gov ID
- NCT07863778
- Acronym / sponsor ID
- SU91-PHRSW-F23-010
- Keywords
- Artificial intelligence, Virtual reality, Non-immersive virtual reality, Speech therapy, Pediatric rehabilitation, Percentage of Consonants Correct, Automatic speech recognition, Speech Blubs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a two-arm, parallel-group, assessor-blinded randomized controlled trial comparing AI-Integrated Virtual Reality Speech Therapy (AI-IVR-ST) with conventional speech therapy. Participants were children aged 5 to 12 years with articulation disorder and/or phonological disorder diagnosed by a qualified speech-language pathologist. Computer-generated block randomization with variable block sizes was used and allocation was concealed using sequentially numbered opaque sealed envelopes. Each group received three 45- to 50-minute clinic sessions per week for 12 weeks. The experimental intervention combined Kinect-based non-immersive virtual reality, AI-assisted Speech Blubs practice, therapist-guided speech generalization, and caregiver-supervised home practice. The control arm received conventional face-to-face speech therapy with a printed home exercise programme. Outcomes were assessed at baseline, Week 6, and Week 12; FACES III and ASHA NOMS were assessed at baseline and Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to AI-IVR-ST or conventional speech therapy, with 32 participants per group.
| Arm | Type | Receives |
|---|---|---|
| Experimental: AI-Integrated Virtual Reality Speech Therapy | Experimental | Other: AI-Integrated Virtual Reality Speech Therapy (AI-IVR-ST)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. |
| Active Comparator: Conventional Speech Therapy | Active comparator | Other: Conventional Speech TherapyParticipants 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- Autism spectrum disorder.
- Cerebral palsy.
- Intellectual disability.
- Hearing impairment incompatible with study assessment.
- Cleft lip and/or palate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Integrated Virtual Reality Speech Therapy (AI-IVR-ST)Also: AI-IVR-STThe 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. | Other | Experimental: AI-Integrated Virtual Reality Speech Therapy |
| Conventional Speech TherapyConventional 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. | Other | Active Comparator: Conventional Speech Therapy |
Primary outcome
Percentage of Consonants Correct (PCC)
Time frame: Baseline, Week 6, and Week 12
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.
6 secondary outcomes
Goldman-Fristoe Test of Articulation, Third Edition (GFTA-3) Standard Score
Time frame: Baseline, Week 6, and Week 12
Peabody Picture Vocabulary Test, Fourth Edition (PPVT-4) Standard Score
Time frame: Baseline, Week 6, and Week 12
Therapy Engagement Composite Score Assessed Using the Study-Specific Therapist-Rated Engagement Checklist
Time frame: Baseline, Week 6, and Week 12
Therapy Adherence
Time frame: Weekly during the 12-week intervention; summary at Week 6 and Week 12
FACES III Total Score
Time frame: Baseline and Week 12
ASHA NOMS Functional Communication/Participation Score
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fariha Ambreen Chaudhry principal investigator
Superior University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Integrated Virtual Reality Speech Therapy (AI-IVR-ST) and Conventional Speech Therapy in people with Speech Sound Disorder and Articulation Disorder, run by Superior University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Consonants Correct (PCC) (time frame: Baseline, Week 6, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.