NCT07129291

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress56%
Apr 2025Mar 2027

Study Start

First participant enrolled

April 17, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

August 12, 2025

Last Update Submit

August 12, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Frenchay Dysarthria Assessment (FDA-2)

    Assesses: Motor speech function. Scoring: A (normal) to E (severely impaired) across speech subsystems.

    24 Months

  • Dysarthria Impact Profile (DIP)

    Assesses: Psychosocial impact of dysarthria. Scoring: 48 items, rated 1-5; higher scores = greater negative impact.

    24 Months

  • Speech Intelligibility Rating Scale (SIRS)

    Assesses: Speech clarity. Scoring: 1 (unintelligible) to 5 (fully intelligible).

    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.

    24 Months

Study Arms (1)

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

Combination Product: Experimental: Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS)

Interventions

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

Dual-Language Dysarthria Self-Assessment and Management Software (D-SAMS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Centers in Punjab

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Dysarthria

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 19, 2025

Study Start

April 17, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations