Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke

NCT05146765 | Completed

• 1 other identifier: D-ST01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot trial will establish the feasibility of a new digitized speech rehabilitation developed for patients with post-stroke dysarthria. For this study, participants will be instructed to use the speech therapy app for 30 minutes to 1 hour per day over a 4-week period.

Conditions

Dysarthria as Late Effect of Stroke

Keywords

Dysarthria; Stroke; digital therapeutics; Speech Disorders; Language Disorders; speech rehabilitation; application; Post-stroke dysarthria

Outcome Measures

Primary Outcomes (1)

• Speech intelligibility

  Speech intelligibility is evaluated with a score of 0 (normal), 1 (intelligible, some differences noticeable), 2 (intelligible, noticeably different), 3 (intelligible with careful listening, some unintelligible), 4 (difficult to understand, many words unintelligible), 5 (usually unintelligible), or 6 (unintelligible).

  Baseline, 4weeks

Secondary Outcomes (1)

• The percent change in score on the Urimal Test of Articulation and Phonology 2 (UTAP2)

  Baseline, 4weeks

Other Outcomes (5)

• National Institute of Health Stroke Scale (NIHSS)

  Baseline, 4weeks

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 4weeks

• Generalized Anxiety disorder-7

  Baseline, 4weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will receive treatment as usual along with the speech therapy app.

Device: Mobile application; Other: Treatment as usual

Control

NO INTERVENTION

The control group will receive treatment as usual only.

Interventions

Mobile application DEVICE

Device: Use of mobile application Participants will be instructed to use the speech therapy app for 30 minutes to one hour per day over a 4-week period.

Intervention

Treatment as usual OTHER

The patients will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Neurologically stable, as determined by the clinician.
• Onset of stroke within four weeks prior to randomization.
• Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist.
• Maintains enough cognitive function to use the speech therapy application without problems, as determined by a Mini-Mental State Exam score of 26 ≥ within 1 month prior to randomization.
• Capable of walking or moving alone or with the assistance of a walking aid (e.g., walkers, canes, or wheelchairs).
• Must have intact vision, hearing, communication skills, and motor skills, as well as comprehension sufficient to proceed with assessment, as judged by the clinician.

You may not qualify if:

• Unable to measure articulatory or orofacial functions due to organic causes/lesions in articulatory and cervical structure.
• Has comorbid neurological conditions that, in the opinion of the investigator, could impair study participation, such as dementia (Alzheimer's disease, vascular dementia, Central Nervous System Infection \[e.g., Human Immunodeficiency Virus, syphilis\], Creutzfeld-Jacob disease, etc.), Pick's disease, Huntington's disease, or Parkinson's disease.
• Has a Mini-Mental State Exam score of 26 or below at the time of screening.
• Has a Clinical Dementia Rating score of 1 ≥ or a Global Deterioration Scale score of 3 ≥ at the time of screening.
• Received dementia treatment within 3 months of screening.
• Takes medication that may impact cognitive function during the clinical trial period.
• Co-medication is prohibited during the entire trial period for the following medications: drugs for dementia treatment, Central Nervous System stimulants, anticholinergics, tricyclic antidepressants, typical antipsychotics, and sleeping pills (excluding rapid-acting sleeping pills).
• Co-medication is permitted if continued use of the following medications has been at a stable dose for 2 months prior to randomization: atypical antipsychotics, anxiolytics, antidepressants (excluding tricyclic antidepressants), thyroid hormone, and rapid-acting sleeping pills.
• Is uneducated or illiterate.
• Has been diagnosed with a serious mental illness such as severe depression, schizophrenia, alcohol addiction, or drug addiction.
• Unable to use D-ST01 due to severe speech impairment, as determined by the clinician.

Sponsors & Collaborators

• Ewha Womans University Seoul Hospital: lead

Study Sites (1)

Ewha Womans University Medical Center

Seoul, 07804, South Korea

Location

Related Publications (1)

• Kim Y, Kim M, Kim J, Song TJ. Smartphone-Based Speech Therapy for Poststroke Dysarthria: Pilot Randomized Controlled Trial Evaluating Efficacy and Feasibility. J Med Internet Res. 2024 Apr 25;26:e56417. doi: 10.2196/56417.

  PMID: 38509662 DERIVED

MeSH Terms

Conditions

Dysarthria; Stroke; Speech Disorders; Language Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Articulation Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tae-Jin Song, MD, PhD

  Department of Neurology, Ewha University College of Medicine, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Outcome Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Department of neurology, Seoul Hospital, Ewha Womans University College of Medicine

Model Details: Pilot trial

Study Record Dates

• First Submitted: November 14, 2021
• First Posted: December 7, 2021
• Study Start: January 18, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)