Dysarthria as Late Effect of StrokeNCT05146765
Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke
A study testing Mobile application and Treatment as usual in people with Dysarthria as Late Effect of Stroke, run by Ewha Womans University Seoul Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dysarthria as Late Effect of Stroke
- What is being tested?
- Mobile application and Treatment as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jan 2022to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke; Pilot Trial
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.
Read the detailed 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.
- Conditions
- Dysarthria as Late Effect of Stroke
- Being tested
- Mobile application, Treatment as usual
- Keywords
- Dysarthria, Stroke, digital therapeutics, Speech Disorders, Language Disorders, speech rehabilitation, application, Post-stroke dysarthria
- Medical subject headings
- Dysarthria, Stroke, Speech Disorders, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationDevice
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.
Treatment as usualOther
The patients will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will receive treatment as usual along with the speech therapy app. Receives: Device: Mobile application; Other: Treatment as usual |
| Control | No intervention | The control group will receive treatment as usual only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 4weeks
Secondary outcomes (1)
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.
Measured: Baseline, 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start18 Jan 2022
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysarthria as Late Effect of StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Jin Song, MD, PhD, Ewha Womans University Seoul Hospital
- Investigators
- Tae-Jin Song, MD, PhD, Principal investigator, Department of Neurology, Ewha University College of Medicine, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146765
- Sponsor's protocol ID
- D-ST01
- Status last verified
- Dec 2023
- First submitted
- 14 Nov 2021
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38509662
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke; Pilot Trial
- ClinicalTrials.gov ID
- NCT05146765
- Acronym / sponsor ID
- D-ST01
- Conditions
- Dysarthria as Late Effect of Stroke
- Keywords
- Dysarthria, Stroke, digital therapeutics, Speech Disorders, Language Disorders, speech rehabilitation, application, Post-stroke dysarthria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ewha Womans University Seoul HospitalUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pilot trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Mobile application, Other: Treatment as usualThe intervention group will receive treatment as usual along with the speech therapy app. |
| Control | No intervention | –The control group will receive treatment as usual only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile applicationDevice: 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. | Device | Intervention |
| Treatment as usualThe patients will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines. | Other | Intervention |
Primary outcome
Speech intelligibility
Time frame: Baseline, 4weeks
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).
1 secondary outcome
The percent change in score on the Urimal Test of Articulation and Phonology 2 (UTAP2)
Time frame: Baseline, 4weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 38509662Kim 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Jin Song, MD, PhD principal investigator
Department of Neurology, Ewha University College of Medicine, Seoul, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application and Treatment as usual in people with Dysarthria as Late Effect of Stroke, run by Ewha Womans University Seoul Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech intelligibility (time frame: Baseline, 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05146765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.