DysarthriaNCT07129291
Development of Dual Language (Urdu and English) Digital Software for SA, Management Of Adult Dysarthria
A study testing Experimental: Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS) in people with Dysarthria, run by Superior University at 1 site in Pakistan.
Trial summary
The research focuses on the development of a dual-language (Urdu and English) digital software designed for the self-assessment and management of adult dysarthria patients. Dysarthria, a motor speech disorder resulting from neurological injury, significantly affects an individual's ability to communicate effectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysarthria
- What is being tested?
- Experimental: Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Apr 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18+) diagnosed with dysarthria due to neurological causes (e.g., stroke, Parkinson's).
- Able to understand and communicate in Urdu and/or English.
- Cognitive ability sufficient to use digital tools for self-assessment.
- Consent to participate in the study.
Who cannot join
- Severe cognitive impairment or dementia limiting participation.
- Co-existing speech disorders unrelated to dysarthria (e.g., aphasia).
- Hearing impairments that prevent use of audio-based software.
- Unwillingness or inability to use digital devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Dual Language (Urdu and English) Digital Software For Self- Assessment And Management Of Adult Dysarthria Patients
The research focuses on the development of a dual-language (Urdu and English) digital software designed for the self-assessment and management of adult dysarthria patients. Dysarthria, a motor speech disorder resulting from neurological injury, significantly affects an individual's ability to communicate effectively.
Read the detailed description
Current assessment tools are often clinician-dependent and predominantly available in English, limiting accessibility for non-English speakers, especially in Pakistan and other Urdu-speaking regions. This study aims to bridge that gap by creating a user-friendly, culturally relevant, and linguistically accessible software platform. The software will enable adult dysarthric patients to monitor their speech abilities, track progress, and participate more actively in their therapy process. It is expected to enhance patient autonomy, improve communication outcomes, and support speech-language pathologists in delivering more efficient care. The dual-language interface ensures broader usability, promoting inclusion and better engagement among diverse user groups in bilingual settings.
- Conditions
- Dysarthria
- Being tested
- Experimental: Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS)
- Medical subject headings
- Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS)Combination product
D-SAMS is a bilingual (Urdu and English) digital tool designed for adult dysarthria patients. It enables users to assess their speech through interactive tasks (e.g., repetition, reading, and pronunciation exercises), receive feedback, and track progress over time. The software includes audio-visual prompts, self-rating scales, and progress charts, and is tailored to accommodate varying levels of dysarthria severity. It supports independent practice and helps speech-language pathologists monitor patients remotely
| Study group | Role | What they receive |
|---|---|---|
| Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS) | Experimental | D-SAMS is a bilingual (Urdu and English) digital tool designed for adult dysarthria patients. It enables users to assess their speech through interactive tasks (e.g., repetition, reading, and pronunciation exercises), receive feedback, and track progress over time. The software includes audio-visual prompts, self-rating scales, and progress charts, and is tailored to accommodate varying levels of dysarthria severity. It supports independent practice and helps speech-language pathologists monitor patients remotely Receives: Combination Product: Experimental: Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frenchay Dysarthria Assessment (FDA-2)
Assesses: Motor speech function. Scoring: A (normal) to E (severely impaired) across speech subsystems.
Measured: 24 Months
Dysarthria Impact Profile (DIP)
Assesses: Psychosocial impact of dysarthria. Scoring: 48 items, rated 1-5; higher scores = greater negative impact.
Measured: 24 Months
Speech Intelligibility Rating Scale (SIRS)
Assesses: Speech clarity. Scoring: 1 (unintelligible) to 5 (fully intelligible).
Measured: 24 Months
Voice Handicap Index-10 (VHI-10) (optional)
Assesses: Patient's perception of voice issues. Scoring: 0-4 per item; total out of 40. Higher = more voice difficulty.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start17 Apr 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysarthriaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129291
- Sponsor's protocol ID
- PhDRSW/Batch-Fall23/2226
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Dual Language (Urdu and English) Digital Software For Self- Assessment And Management Of Adult Dysarthria Patients
- ClinicalTrials.gov ID
- NCT07129291
- Acronym / sponsor ID
- PhDRSW/Batch-Fall23/2226
- Conditions
- Dysarthria
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 Aug 2025 (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.
The research focuses on the development of a dual-language (Urdu and English) digital software designed for the self-assessment and management of adult dysarthria patients. Dysarthria, a motor speech disorder resulting from neurological injury, significantly affects an individual's ability to communicate effectively.
Detailed description
Current assessment tools are often clinician-dependent and predominantly available in English, limiting accessibility for non-English speakers, especially in Pakistan and other Urdu-speaking regions. This study aims to bridge that gap by creating a user-friendly, culturally relevant, and linguistically accessible software platform. The software will enable adult dysarthric patients to monitor their speech abilities, track progress, and participate more actively in their therapy process. It is expected to enhance patient autonomy, improve communication outcomes, and support speech-language pathologists in delivering more efficient care. The dual-language interface ensures broader usability, promoting inclusion and better engagement among diverse user groups in bilingual settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS) | Experimental | Combination Product: Experimental: Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS)D-SAMS is a bilingual (Urdu and English) digital tool designed for adult dysarthria patients. It enables users to assess their speech through interactive tasks (e.g., repetition, reading, and pronunciation exercises), receive feedback, and track progress over time. The software includes audio-visual prompts, self-rating scales, and progress charts, and is tailored to accommodate varying levels of dysarthria severity. It supports independent practice and helps speech-language pathologists monitor patients remotely |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (18+) diagnosed with dysarthria due to neurological causes (e.g., stroke, Parkinson's).
- Able to understand and communicate in Urdu and/or English.
- Cognitive ability sufficient to use digital tools for self-assessment.
- Consent to participate in the study.
Key exclusion criteria (4 listed)
- Severe cognitive impairment or dementia limiting participation.
- Co-existing speech disorders unrelated to dysarthria (e.g., aphasia).
- Hearing impairments that prevent use of audio-based software.
- Unwillingness or inability to use digital devices.
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 |
|---|---|---|
| Experimental: Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS)D-SAMS is a bilingual (Urdu and English) digital tool designed for adult dysarthria patients. It enables users to assess their speech through interactive tasks (e.g., repetition, reading, and pronunciation exercises), receive feedback, and track progress over time. The software includes audio-visual prompts, self-rating scales, and progress charts, and is tailored to accommodate varying levels of dysarthria severity. It supports independent practice and helps speech-language pathologists monitor patients remotely | Combination product | Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS) |
Primary outcome
Frenchay Dysarthria Assessment (FDA-2)
Time frame: 24 Months
Assesses: Motor speech function. Scoring: A (normal) to E (severely impaired) across speech subsystems.
Dysarthria Impact Profile (DIP)
Time frame: 24 Months
Assesses: Psychosocial impact of dysarthria. Scoring: 48 items, rated 1-5; higher scores = greater negative impact.
Speech Intelligibility Rating Scale (SIRS)
Time frame: 24 Months
Assesses: Speech clarity. Scoring: 1 (unintelligible) to 5 (fully intelligible).
Voice Handicap Index-10 (VHI-10) (optional)
Time frame: 24 Months
Assesses: Patient's perception of voice issues. Scoring: 0-4 per item; total out of 40. Higher = more voice difficulty.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS) in people with Dysarthria, run by Superior University at 1 site 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Frenchay Dysarthria Assessment (FDA-2) (time frame: 24 Months). The study lists 4 primary outcomes in all. 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 19 Aug 2025.