Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke

Dysarthria as Late Effect of Stroke Clinical Trial

Official title:

Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke; Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05146765
• Other study ID #: D-ST01
• Status: Completed
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: August 30, 2022

Study information

• Verified date: December 2023
• Source: Ewha Womans University Seoul Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A total of 40 patients with post-stroke dysarthria will be recruited and randomly divided into intervention and control groups.

Patients in the intervention group will be instructed to receive speech treatments including oro-motor exercise, phonation, articulation, resonance, syllable repetition, and reading exercise (App on mobile devices). Daily sessions will be provided during a 4-week period. Both groups will also receive treatment as usual. The aim of the study is to investigate the efficacy of mobile-based speech therapy in patients with dysarthria in the acute phase following stroke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Neurologically stable, as determined by the clinician.

2. Onset of stroke within four weeks prior to randomization.

3. Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist.

4. 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.

5. Capable of walking or moving alone or with the assistance of a walking aid (e.g., walkers, canes, or wheelchairs).

6. Must have intact vision, hearing, communication skills, and motor skills, as well as comprehension sufficient to proceed with assessment, as judged by the clinician.

Exclusion Criteria:

1. Unable to measure articulatory or orofacial functions due to organic causes/lesions in articulatory and cervical structure.

2. 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.

3. Has a Mini-Mental State Exam score of 26 or below at the time of screening.

4. Has a Clinical Dementia Rating score of 1 = or a Global Deterioration Scale score of 3 = at the time of screening.

5. Received dementia treatment within 3 months of screening.

6. Takes medication that may impact cognitive function during the clinical trial period.

7. 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).

8. 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.

9. Is uneducated or illiterate.

10. Has been diagnosed with a serious mental illness such as severe depression, schizophrenia, alcohol addiction, or drug addiction.

11. Unable to use D-ST01 due to severe speech impairment, as determined by the clinician.

Related Conditions & MeSH terms

• Dysarthria
• Dysarthria as Late Effect of Stroke
• Stroke

Intervention

Device:
• Mobile application
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.

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

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University Seoul Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	National Institute of Health Stroke Scale (NIHSS)	NIHSS will be used to assess stroke-related neurologic deficits. The NIHSS scale is made up of 11 different elements that evaluate specific abilities; level of consciousness (LOC), best gaze, visual field, facial palsy, motor arm, motor leg, limb ataxia, sensory, best language, dysarthria, extinction, inattention. The score ranges from 0 to 42; higher scores indicate more severe stroke symptoms.	Baseline, 4weeks
Other	Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is a nine-item self-reported questionnaire that is used to assess depressive symptoms. The score ranges from 0 to 27, with lower scores indicating less depressive severity.	Baseline, 4weeks
Other	Generalized Anxiety disorder-7	GAD-7(Generalized Anxiety disorder-7) will be used to assess anxiety. The GAD-7(Generalized Anxiety disorder-7) is a seven-item self-reported questionnaire that evaluates anxiety symptoms. The score ranges from 0 to 21, with lower scores indicating lower anxiety symptoms.	Baseline, 4weeks
Other	Euro Quality of Life (EQ-5D)	EQ-5D will be used to assess the quality of life. The EQ-5D is a self-report questionnaire that measures health-related quality of life. The questionnaire consists of five dimensions: mobility, self-care, ordinary activities, discomfort, and mood state related to anxiety or depression. The responses indicate three levels of severity ("no problems", "some problems", and "extreme problems") within each EQ-5D dimension.	Baseline, 4weeks
Other	Modified Computer Self-Efficacy Scale (mCSES)	mCSES will be used to assess participants' perceptions of self-efficacy with respect to using a computerized system. The mCSES is a 10-item self-reported questionnaire. The score ranges from 0 to 100; higher scores indicate a stronger sense of personal competence.	Baseline, 4weeks
Primary	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	The percent change in score on the Urimal Test of Articulation and Phonology 2 (UTAP2)	he UTAP2, an essential tool for determining articulatory proficiency, will be employed to evaluate the Percentage of Consonants Correct (PCC), a crucial metric for identifying irregularities in articulation. Study participants will be instructed to read all 30 words from the UTAP2 word-level test. Following this, evaluators will calculate the PCC, expressed as a percentage, using the 94 consonants included in these words. This methodology acknowledges that a PCC of 0% signifies lower articulatory accuracy, whereas a PCC of 100% reflects a higher level of precision.	Baseline, 4weeks