Dysarthria As Late Effect of StrokeNCT05865106
The Efficacy and Feasibility of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria
A study testing Smartphone-based speech therapy and Traditional speech therapy 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 clinical trial aims to determine if a new smartphone-based speech therapy is effective and feasible for patients with post-stroke dysarthria. Participants in the intervention group will use the speech therapy app for 1 hour per day, 5 days per week, over a 4-week period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysarthria As Late Effect of Stroke
- What is being tested?
- Smartphone-based speech therapy and Traditional speech therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2023to 20 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ewha Womans University Medical Center
Seoul, Seoul, 07804
About this study
Official title: A Prospective, Randomized, Multi-Center Pilot Trial to Evaluate the Efficacy and Feasibility of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria
This clinical trial aims to determine if a new smartphone-based speech therapy is effective and feasible for patients with post-stroke dysarthria. Participants in the intervention group will use the speech therapy app for 1 hour per day, 5 days per week, over a 4-week period. The control group will receive the same duration and frequency of traditional speech therapy as the intervention group. The study will help us understand if smartphone-based speech therapy is a viable treatment option for post-stroke dysarthria patients.
Read the 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.
- Conditions
- Dysarthria As Late Effect of Stroke
- Being tested
- Smartphone-based speech therapy, Traditional speech therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based speech therapyDevice
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.
Traditional speech therapyOther
Participants will receive treatment maintaining the same frequency as the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-based speech therapy | Experimental | 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. Receives: Device: Smartphone-based speech therapy |
| Traditional speech therapy | Other | 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. Receives: Other: Traditional speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech intelligibility
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.
Measured: Baseline, 4 weeks
Secondary outcomes (3)
Maximum phonation Time (MPT)
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.
Measured: Baseline, 4 weeks
Oral-diadochokinesis (DDK)
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.
Measured: Baseline, 4 weeks
Percentage of Consonants Correct (PCC, %)
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).
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jun 2023
- Primary completion20 May 2024
- Study completion20 May 2024
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ewha Womans University Mokdong Hospital, National Rehabilitation Center, Seoul, Korea
- Responsible party
- Principal investigator, Tae-Jin Song, MD, PhD, Ewha Womans University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865106
- Sponsor's protocol ID
- SEUMC 2023-02-002
- Status last verified
- Aug 2024
- First submitted
- 8 May 2023
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim Y, Kim M, Kim J, Song TJ. Efficacy and feasibility of a digital speech therapy for post-stroke dysarthria: protocol for a randomized controlled trial. Front Neurol. 2024 Jan 31;15:1305297. doi: 10.3389/fneur.2024.1305297. eCollection 2024.
PubMed 38356882
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center Pilot Trial to Evaluate the Efficacy and Feasibility of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria
- ClinicalTrials.gov ID
- NCT05865106
- Acronym / sponsor ID
- SEUMC 2023-02-002
- Conditions
- Dysarthria As Late Effect of Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ewha Womans University Seoul HospitalUniversity, hospital or other
- Collaborators
- Ewha Womans University Mokdong Hospital, National Rehabilitation Center, Seoul, Korea
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 18 May 2023 (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 clinical trial aims to determine if a new smartphone-based speech therapy is effective and feasible for patients with post-stroke dysarthria. Participants in the intervention group will use the speech therapy app for 1 hour per day, 5 days per week, over a 4-week period. The control group will receive the same duration and frequency of traditional speech therapy as the intervention group. The study will help us understand if smartphone-based speech therapy is a viable treatment option for post-stroke dysarthria patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone-based speech therapy | Experimental | Device: Smartphone-based speech therapySmartphone-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. |
| Traditional speech therapy | Other | Other: Traditional speech therapyTraditional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Smartphone-based speech therapyParticipants will be instructed to use the speech therapy app for 1 hour per day (5 days for 1 week) over a 4-week period. | Device | Smartphone-based speech therapy |
| Traditional speech therapyParticipants will receive treatment maintaining the same frequency as the intervention group. | Other | Traditional speech therapy |
Primary outcome
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.
3 secondary outcomes
Maximum phonation Time (MPT)
Time frame: Baseline, 4 weeks
Oral-diadochokinesis (DDK)
Time frame: Baseline, 4 weeks
Percentage of Consonants Correct (PCC, %)
Time frame: Baseline, 4 weeks
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 30 Aug 2024.
- Derived from this study: PubMed 38356882Kim Y, Kim M, Kim J, Song TJ. Efficacy and feasibility of a digital speech therapy for post-stroke dysarthria: protocol for a randomized controlled trial. Front Neurol. 2024 Jan 31;15:1305297. doi: 10.3389/fneur.2024.1305297. eCollection 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based speech therapy and Traditional speech therapy 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 7 inclusion and 9 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 30 Aug 2024. 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, 4 weeks). 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 NCT05865106, 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 30 Aug 2024.