An interventional study of Mobile application and Treatment as usual in Dysarthria as Late Effect of Stroke, sponsored by Ewha Womans University Seoul Hospital. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2023-12-20.
Sponsored by Ewha Womans University Seoul Hospital · Not applicable, Interventional, and Treatment
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.
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.
60 studies on the registry are indexed under Dysarthria; 19 are open to participants now.
This study's enrollment of 40 is close to the median of 39 across 44 interventional studies indexed under Dysarthria.
Browse Dysarthria studies →Ewha Womans University Seoul Hospital is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group will receive treatment as usual along with the speech therapy app.
Device: Mobile application · Other: Treatment as usual
The control group will receive treatment as usual only.
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.
The patients will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.
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).
Time frame: Baseline, 4weeks
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.
Time frame: Baseline, 4weeks
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.
Time frame: Baseline, 4weeks
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.
Time frame: Baseline, 4weeks
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.
Time frame: Baseline, 4weeks
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.
Time frame: Baseline, 4weeks
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.
Time frame: Baseline, 4weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Aug 2022, 7 months.
Of 34 interventional studies with no phase under Dysarthria, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Ewha Womans University Seoul Hospital