- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05865106
The Efficacy and Feasibility of Smartphone-Based Speech Therapy for People With Post-Stroke Dysarthria
A Prospective, Randomized, Multi-Center Pilot Trial to Evaluate the Efficacy and Feasibility of Smartphone-Based Speech Therapy for People With Post-Stroke Dysarthria
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 76 patients with post-stroke dysarthria will be recruited and stratified by the onset period into acute-subacute (within 6month after index stroke) and chronic (after 6 months after index stroke). Then participants are randomly divided into intervention and control groups.
Patients in the intervention group will be instructed to use smartphone-based speech therapy applications, including oro-motor exercise, phonation, articulation, resonance, syllable repetition, and reading exercises. After the baseline evaluation, treatment goals, and contents will be determined with a speech-language pathologist according to the condition of individual patients. Daily sessions will be provided for 1 hour per day, 5 days per week, over a 4-week period.
Patients in the control group will be instructed to receive traditional speech therapy. Traditional speech therapy can include face-to-face speech therapy, including oro-motor exercises, reading aloud slowly and clearly, and practicing proper breathing and sustained speech. To maintain the same dose and frequency as the intervention group, 60 minutes of treatment will be performed five days a week (e.g., two days of face-to-face speech therapy per week (60 minutes) + three days of self-training through the reading task workbook (60 minutes).
The aim of the study is to establish smartphone-based speech therapy is non-inferior to traditional speech therapy for improving speech intelligibility.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 07804
- Recruiting
- Ewha womans university medical center
-
Contact:
- Tae Jin Song, MD, PhD
- Phone Number: +82-2-6986-3307
- Email: knstar@hanmail.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 or over.
- Neurologically stable stroke patients diagnosed by a stroke specialist neurologist.
- Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist.
- First-ever stroke patients without previous stroke history.
- Patients with sufficient cognitive abilities to operate the smartphone-based speech therapy application (Mini-Mental State Exam score ≥ 26)
- As judged by the neurology specialists: patients with sufficient vision, hearing, communication skills, and motor skills to participate in this study
- Must have voluntarily understood the trial and signed a consent form agreeing to comply with precautions.
Exclusion Criteria:
- Co-existing language disorder (e.g., aphasia). Aphasia will be determined by a stroke specialist.
- Co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism).
- Diagnosis of severe mental disorders as determined by a clinician (e.g., depression, schizophrenia, alcohol addiction, or drug addiction).
- Patients taking concomitant medications that could affect the trial results during the study period (e.g., cognitive dysfunction medications, anticholinergics, anti-epileptic drugs, anti-anxiety drugs, antidepressants, antipsychotics, and hypnotics).
- Patients unable to use/access smartphone technology.
- Illiterate patients.
- Patients unable to communicate in Korean.
- Is unsuitable for participation due to other reasons, as determined by the investigator.
- Has refused to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Smartphone-based speech therapy
Smartphone-based speech therapy: Participants will be instructed to use smartphone-based speech therapy (application), including oro-motor exercises, phonation, articulation, resonance, syllable repetition, and reading exercises.
|
Participants will be instructed to use the speech therapy app for 1 hour per day (5 days for 1 week) over a 4-week period.
|
Other: Traditional speech therapy
Traditional speech therapy: Traditional speech therapy methods, such as face-to-face sessions, oro-motor exercises for the tongue, lips, chin, and jaw, reading aloud slowly and clearly, and practicing proper breathing and sustained speech, will be employed.
|
Participants will receive treatment maintaining the same frequency as the intervention group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech intelligibility
Time Frame: Baseline, 4 weeks
|
The change in speech intelligibility from baseline to 4 weeks post-intervention will be assessed.
Speech intelligibility will be evaluated by having three naive listeners transcribe the participants' recorded speech.
These transcriptions will then be compared to the original sentences to calculate a percentage score representing intelligibility.
The final intelligibility score will be calculated as the average of the scores from the three naive listeners.
A higher percentage indicates greater speech intelligibility.
|
Baseline, 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum phonation Time (MPT)
Time Frame: Baseline, 4 weeks
|
The change in maximum phonation time (MPT) from baseline to 4 weeks post-intervention will be assessed.
MPT will be used to assess participants' maximum phonation time.
The speech evaluator instructs the patient to take a comfortable breath and then produce the sound /a/ for as long as possible.
The task is performed twice, and the maximum duration of the two measurements is used.
|
Baseline, 4 weeks
|
Oral-diadochokinesis (DDK)
Time Frame: Baseline, 4 weeks
|
The Oral-diadochokinesis (DDK) change from baseline to 4 weeks post-intervention will be assessed.
DDK will be used to assess articulation rate, regularity, and accuracy.
Participants are instructed to repeat the syllables /pa/, /ta/, /ka/, and /pataka/ as quickly and accurately as possible.
The number of repetitions is divided by the duration of the task.
|
Baseline, 4 weeks
|
Percentage of Consonants Correct (PCC, %)
Time Frame: Baseline, 4 weeks
|
The Percentage of Consonants Correct (PCC, %) change from baseline to 4 weeks post-intervention will be assessed.
PCC is evaluated as a percentage score calculated from the Urimal Test of Articulation and Phonology 2 (UTAP2).
|
Baseline, 4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 4 weeks
|
PHQ-9 will be used to assess depression.
The PHQ-9 is a nine-item self-reported questionnaire for the measurement of depressive symptoms during the last two weeks.
|
Baseline, 4 weeks
|
Quality of Life in the Dysarthric Speaker (QOL-Dys)
Time Frame: Baseline, 4 weeks
|
QOL-Dys will be used to assess the comprehensive quality of life of individuals with dysarthria.
The questionnaire consists of four dimensions: characteristics of speech, situational difficulties, use of compensation strategies, and perception of others.
The responses are rated on a 5-point scale from 0 to 4, indicating the extent to which participants agree with each statement.
|
Baseline, 4 weeks
|
System Usability Questionnaire (SUS)
Time Frame: 4 weeks
|
SUS will be used to assess user's subjective views of a system's usability.
SUS will only be used in the intervention group at the end of treatment.
|
4 weeks
|
Application usage logs
Time Frame: 4 weeks
|
The log data will be used to evaluate compliance and acoustic factors.
During the 4-week experimental period, the application login time, daily task completion rate, and raw data (.wav) of patients' voices are stored on the server for analysis.
|
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Language Disorders
- Speech Disorders
- Articulation Disorders
- Stroke
- Dysarthria
- Communication Disorders
Other Study ID Numbers
- SEUMC 2023-02-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dysarthria as Late Effect of Stroke
-
Ewha Womans University Seoul HospitalCompletedDysarthria as Late Effect of StrokeKorea, Republic of
-
Isra UniversityUnknownDysarthria as Late Effect of StrokePakistan
-
Ewha Womans University Seoul HospitalEwha Womans University Mokdong Hospital; National Rehabilitation Center, Seoul...Not yet recruitingDysarthria as Late Effect of Stroke
-
Lone FornerDanish Cancer SocietyUnknownLate Effect of RadiationDenmark
-
Rennes University HospitalCompletedLeft-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular AccidentFrance
-
Far Eastern Memorial HospitalUnknownThoracic Neoplasms | Late Effect of RadiationTaiwan
-
Moustafa Mohammed AboueleaRecruitingEffect of Adding GnRHa as Luteal Phase Support in Antagonist ART CyclesEgypt
-
The Netherlands Cancer InstituteCompletedQuality of Life | Cancer | Lifestyle | Survivorship | Late EffectNetherlands
-
Islamabad Medical and Dental CollegeRecruitingEffect of Aloe Vera Gel as an Intracanal Medicament in Asymptomatic Periapical LesionsPakistan
-
Loma Linda UniversityCompletedHemiparesis as Late Effect of Cerebrovascular DiseaseUnited States
Clinical Trials on Smartphone-based speech therapy
-
Ewha Womans University Seoul HospitalEwha Womans University Mokdong Hospital; National Rehabilitation Center, Seoul...Not yet recruitingDysarthria as Late Effect of Stroke
-
Abant Izzet Baysal UniversityCompleted
-
The University of Texas at DallasNational Institute on Deafness and Other Communication Disorders (NIDCD)Recruiting
-
National Yang Ming UniversityTri-Service General HospitalRecruiting
-
National Taiwan University HospitalNot yet recruitingAutism | Language Delay | Speech Disorders in Children
-
Assistance Publique Hopitaux De MarseilleRecruitingEpilepsy | Temporal Lobe Epilepsy | AnomiaFrance
-
Hospital de Clinicas de Porto AlegreCompletedOral Cancer | Intelligibility, Speech | Tongue Cancer | Jaw CancerBrazil
-
Klinik ArlesheimUniversity of Bern; Paracelsus-Spital RichterswilCompletedHypertension
-
Johns Hopkins UniversityWithdrawn
-
Iran University of Medical SciencesCompletedParkinson Disease | Speech Disorders | Voice DisordersIran, Islamic Republic of