Stuttering, AdultAl-LisaanNCT06059729
Effects of Al-Lisaan Urdu Digital Software for Self-Assessment and Treatment of Adult Stutters
A study testing Al-Lisaan in people with Stuttering, Adult, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The study plans to find the efficacy of a digital application/software, Al-lisan that adult stutters can be used for assessment and management of their stuttering. The Software has been developed with the help of a software engineer. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stuttering, Adult
- What is being tested?
- Al-Lisaan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesPakistan
- Study dates
- 11 Sep 2023to 1 Jan 2024
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria will be Stutters who are above the age of 19 and who have not taken regular therapy from last one year
Who cannot join
- Adults with neurogenic stuttering or any other organic cause will be excluded
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Hafsa Noreen
Lahore, Punjab Province
Rex Medical Center
Lahore, Punjab Province
About this study
Official title: Effect of Al-Lisaan Digital Application on Adult Stutters
The study plans to find the efficacy of a digital application/software, Al-lisan that adult stutters can be used for assessment and management of their stuttering. The Software has been developed with the help of a software engineer. After the current trends employed by Speech language pathologists explored through qualitative study design, the manual which is under development process through a focused group in which assessment and treatment options of the software were finalized. The next step will include the reliability and validity of the software for assessment and management of adult stutters followed by finding the efficacy of the software. As this Application will be in Urdu language it will assist less literate and those living in peripheries to assess or provide self-treatment options to the persons who stutter. It will allow adults for self-assessment and treatment options in Urdu language.
Read the detailed description
The term stuttering refers to the dis-fluent pattern of speech. In adult stuttering it's a learned pattern of dis-fluent production that may become the part of their speech permanently. It affects 1% of the worldwide population. There are many therapeutic techniques to treat the stuttering in adults. Self-help therapy is common to use. Besides the personalized treatment of self-help therapy by adult stutters, there are many digital applications available and used by many adult stutters worldwide. Few are StammerApp, Stamurai and SMAAT. The objective of the study is to develop a digital application/software that adult stutters can be used for assessment and management of their stuttering. This study being a part of PhD project, started in March 2020 and until now, the current trends employed by Speech language pathologists have been explored through qualitative study design. The manual was developed through a focused group in which assessment and treatment options of the software were finalized. The Software has been developed with the help of a software engineer. The objective of this study is to find the effects of Al-lisan Urdu Digital Software for Self-Assessment and Treatment of Adult Stutters. For this step we are applying for the grant. As this Application will be in Urdu language it will assist less literate and those living in peripheries to assess or provide self-treatment options to the persons who stutter. It will allow adults for self-assessment and treatment options in Urdu language.
- Conditions
- Stuttering, Adult
- Being tested
- Al-Lisaan
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al-LisaanDevice
Al-Lisaan is a digital application for the self assessment and management of adult stutters.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Al-Lisaan digital application will be given to participants for self assessment and management Receives: Device: Al-Lisaan |
| Controlled group | Other | Home plan will be given Receives: Device: Al-Lisaan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stutter Severity Index
Stutter's severity will be measured Pre and Post experimental study.
Measured: six weeks
Secondary outcomes (1)
Stuttering Severity Index
Stutter's severity will be measured Pre and Post experimental study.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start11 Sep 2023
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stuttering, AdultStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hafsa Noreen, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059729
- Sponsor's protocol ID
- 27231-Hafsa Noreen
- Acronym
- Al-Lisaan
- Status last verified
- Apr 2024
- First submitted
- 22 Sep 2023
- Last updated
- 3 Apr 2024
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Al-Lisaan Digital Application on Adult Stutters
- ClinicalTrials.gov ID
- NCT06059729
- Acronym / sponsor ID
- Al-Lisaan / 27231-Hafsa Noreen
- Conditions
- Stuttering, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 29 Sep 2023 (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 study plans to find the efficacy of a digital application/software, Al-lisan that adult stutters can be used for assessment and management of their stuttering. The Software has been developed with the help of a software engineer. After the current trends employed by Speech language pathologists explored through qualitative study design, the manual which is under development process through a focused group in which assessment and treatment options of the software were finalized. The next step will include the reliability and validity of the software for assessment and management of adult stutters followed by finding the efficacy of the software. As this Application will be in Urdu language it will assist less literate and those living in peripheries to assess or provide self-treatment options to the persons who stutter. It will allow adults for self-assessment and treatment options in Urdu language.
Detailed description
The term stuttering refers to the dis-fluent pattern of speech. In adult stuttering it's a learned pattern of dis-fluent production that may become the part of their speech permanently. It affects 1% of the worldwide population. There are many therapeutic techniques to treat the stuttering in adults. Self-help therapy is common to use. Besides the personalized treatment of self-help therapy by adult stutters, there are many digital applications available and used by many adult stutters worldwide. Few are StammerApp, Stamurai and SMAAT. The objective of the study is to develop a digital application/software that adult stutters can be used for assessment and management of their stuttering. This study being a part of PhD project, started in March 2020 and until now, the current trends employed by Speech language pathologists have been explored through qualitative study design. The manual was developed through a focused group in which assessment and treatment options of the software were finalized. The Software has been developed with the help of a software engineer. The objective of this study is to find the effects of Al-lisan Urdu Digital Software for Self-Assessment and Treatment of Adult Stutters. For this step we are applying for the grant. As this Application will be in Urdu language it will assist less literate and those living in peripheries to assess or provide self-treatment options to the persons who stutter. It will allow adults for self-assessment and treatment options in Urdu language.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Al-LisaanAl-Lisaan digital application will be given to participants for self assessment and management |
| Controlled group | Other | Device: Al-LisaanHome plan will be given |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria will be Stutters who are above the age of 19 and who have not taken regular therapy from last one year
Key exclusion criteria (1 listed)
- Adults with neurogenic stuttering or any other organic cause will be excluded
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 |
|---|---|---|
| Al-LisaanAl-Lisaan is a digital application for the self assessment and management of adult stutters. | Device | Controlled group, Experimental group |
Primary outcome
Stutter Severity Index
Time frame: six weeks
Stutter's severity will be measured Pre and Post experimental study.
1 secondary outcome
Stuttering Severity Index
Time frame: six weeks
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 3 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Stuttering, Adult
Not yet recruiting
Effectiveness of Virtually Simulated Intervention for Patients Having Stuttering
Stuttering
Recruiting
Using Non-invasive Brain Stimulation to Explore Potential Treatments to Reduce Speech Errors in Adults Who Stutter
Stuttering, Fluency Disorder
Recruiting
Transcranial Alternating Current Stimulation (tACS) in Stuttering
Stuttering, Adult, Stuttering, Childhood
RecruitingPhase 1
Dopamine and Sensorimotor Function in Stuttering
Stuttering, Adult
Recruiting
Using Transcranial Magnetic Stimulation to Treat Stuttering
Stuttering, Adult
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.
hafsa Noreen, PhD* principal investigator
Riphah International 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 Al-Lisaan in people with Stuttering, Adult, run by Riphah International 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 1 inclusion and 1 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 3 Apr 2024. 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?
Stutter Severity Index (time frame: six weeks). 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 3 Apr 2024.