NCT06059729

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

September 22, 2023

Last Update Submit

April 2, 2024

Conditions

Stuttering, Adult

Outcome Measures

Primary Outcomes (1)

  • Stutter Severity Index

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

    six weeks

Secondary Outcomes (1)

  • Stuttering Severity Index

    six weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Device: Al-Lisaan

Controlled group

OTHER

Home plan will be given

Device: Al-Lisaan

Interventions

Al-LisaanDEVICE

Al-Lisaan is a digital application for the self assessment and management of adult stutters.

Controlled groupExperimental group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Adults with neurogenic stuttering or any other organic cause will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hafsa Noreen

Lahore, Punjab Province, Pakistan

Location

Rex Medical Center

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • hafsa Noreen, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2023

First Posted

September 29, 2023

Study Start

September 11, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

April 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)