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Effects of Al-Lisaan Urdu Digital Software for Self-Assessment and Treatment of Adult Stutters (Al-Lisaan)

Primary Purpose

Stuttering, Adult

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Al-Lisaan
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stuttering, Adult

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Inclusion criteria will be Stutters who are above the age of 19 and who have not taken regular therapy from last one year Exclusion Criteria: Adults with neurogenic stuttering or any other organic cause will be excluded

Sites / Locations

  • Hafsa NoreenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Controlled group

Arm Description

Al-Lisaan digital application will be given to participants for self assessment and management

Home plan will be given

Outcomes

Primary Outcome Measures

Stutter Severity Index
Stutter's severity will be measured Pre and Post experimental study.

Secondary Outcome Measures

Stuttering Severity Index
Stutter's severity will be measured Pre and Post experimental study.

Full Information

First Posted
September 22, 2023
Last Updated
September 22, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06059729
Brief Title
Effects of Al-Lisaan Urdu Digital Software for Self-Assessment and Treatment of Adult Stutters
Acronym
Al-Lisaan
Official Title
Effect of Al-Lisaan Digital Application on Adult Stutters
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
November 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Al-Lisaan digital application will be given to participants for self assessment and management
Arm Title
Controlled group
Arm Type
Other
Arm Description
Home plan will be given
Intervention Type
Device
Intervention Name(s)
Al-Lisaan
Intervention Description
Al-Lisaan is a digital application for the self assessment and management of adult stutters.
Primary Outcome Measure Information:
Title
Stutter Severity Index
Description
Stutter's severity will be measured Pre and Post experimental study.
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Stuttering Severity Index
Description
Stutter's severity will be measured Pre and Post experimental study.
Time Frame
six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria will be Stutters who are above the age of 19 and who have not taken regular therapy from last one year Exclusion Criteria: Adults with neurogenic stuttering or any other organic cause will be excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hafsa Noreen, PhD*
Phone
03454501377
Email
hafsa.noreen@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hafsa Noreen, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hafsa Noreen
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafsa Noreen, PhD*
Phone
03454501377
Email
hafsa.noreen@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Nazia Mumtaz, PhD
Phone
03454501377
Email
nazia.mumtaz@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Hafsa Noreen, PhD*

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Al-Lisaan Urdu Digital Software for Self-Assessment and Treatment of Adult Stutters

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