Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-03 @ 12:33 AM
Study NCT ID:
NCT05877950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-30
First Post:
2023-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-17', 'lastUpdatePostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Baseline, 4 weeks', 'description': '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.'}, {'measure': 'Quality of Life in the Dysarthric Speaker (QOL-Dys)', 'timeFrame': 'Baseline, 4 weeks', 'description': '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.'}, {'measure': 'Communicative Effectiveness Survey (CES)', 'timeFrame': 'Baseline, 4 weeks', 'description': 'CES will be used to assess the communication efficiency of individuals with dysarthria in daily situations. The rating scale consists of 8 items and uses a 7-category rating scale ranging from "1 = not effective at all" to "7 = extremely effective" for everyday speaking situations.'}, {'measure': 'System Usability Questionnaire (SUS)', 'timeFrame': '4 weeks', 'description': "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."}, {'measure': 'Application usage logs', 'timeFrame': '4 weeks', 'description': "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."}], 'primaryOutcomes': [{'measure': 'Speech intelligibility', 'timeFrame': 'Baseline, 4 weeks', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Maximum phonation Time (MPT)', 'timeFrame': 'Baseline, 4 weeks', 'description': "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."}, {'measure': 'Oral-diadochokinesis (DDK)', 'timeFrame': 'Baseline, 4 weeks', 'description': '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.'}, {'measure': 'Percentage of Consonants Correct (PCC, %)', 'timeFrame': 'Baseline, 4 weeks', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysarthria As Late Effect of Stroke']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to determine if a new smartphone-based speech therapy is effective self-treatment method for patients with post-stroke dysarthria. For this study, 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 active control group will receive home-based speech therapy with the same duration and frequency as the intervention group.\n\nThe study will help us understand if smartphone-based speech therapy is a viable treatment option for post-stroke dysarthria patients.', 'detailedDescription': 'In this study, 100 patients with post-stroke dysarthria will be recruited and stratified into acute-subacute (within 1 month after index stroke) and chronic (after 6 months after index stroke) groups. Participants will then be randomly assigned to either the intervention or active control group.\n\nPatients in the intervention group will use a smartphone-based speech therapy app that includes oro-motor exercise, phonation, articulation, resonance, syllable repetition, and reading exercises. Treatment goals and contents will be determined based on individual patient conditions by a speech-language pathologist after the baseline evaluation. Participants will receive daily sessions for 1 hour per day, 5 days per week, over a 4-week period.\n\nPatients in the active control group will receive home-based speech therapy, which includes oro-motor exercises and reading tasks from a workbook, for the same frequency as the intervention group. Both groups will also receive usual stroke care.\n\nThe study aims to evaluate the efficacy of mobile-based speech therapy compared to home-based speech therapy in improving speech intelligibility scores 4 weeks after baseline for patients with dysarthria in the acute-subacute and chronic phases following stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged 18 or over.\n2. Neurologically stable stroke patients diagnosed by a stroke specialist neurologist.\n3. Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist.\n4. First-ever stroke patients without previous stroke history.\n5. Patients with sufficient cognitive abilities to operate the smartphone-based speech therapy application (Mini-Mental State Exam score ≥ 26)\n6. As judged by the neurology specialists: patients with sufficient vision, hearing, communication skills, and motor skills to participate in this study\n7. Must have voluntarily understood the trial and signed a consent form agreeing to comply with precautions.\n\nExclusion Criteria:\n\n1. Co-existing language disorder (e.g., aphasia). Aphasia will be determined by a stroke specialist.\n2. Co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism).\n3. Diagnosis of severe mental disorders as determined by a clinician (e.g., depression, schizophrenia, alcohol addiction, or drug addiction).\n4. 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).\n5. Patients unable to use/access smartphone technology.\n6. Illiterate patients.\n7. Patients unable to communicate in Korean.\n8. Is unsuitable for participation due to other reasons, as determined by the investigator.\n9. Has refused to participate in the study."}, 'identificationModule': {'nctId': 'NCT05877950', 'briefTitle': 'The Effectiveness of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University Seoul Hospital'}, 'officialTitle': 'A Prospective, Randomized, Multi-Centered Clinical Trial to Investigate the Effectiveness of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria', 'orgStudyIdInfo': {'id': 'SEUMC 2023-02-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smartphone-based speech therapy with usual stroke care', 'description': '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.\n\nUsual stroke care: Participants will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.', 'interventionNames': ['Device: Smartphone-based speech therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home-based speech therapy with usual stroke care', 'description': 'Home-based speech therapy: Participants will receive treatment such as oro-motor exercises and reading tasks from a workbook.\n\nUsual stroke care: Participants will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.', 'interventionNames': ['Other: Home-based speech therapy']}], 'interventions': [{'name': 'Smartphone-based speech therapy', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Smartphone-based speech therapy with usual stroke care']}, {'name': 'Home-based speech therapy', 'type': 'OTHER', 'description': 'Participants will receive treatment maintaining the same frequency as the intervention group.', 'armGroupLabels': ['Home-based speech therapy with usual stroke care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ewha Womans University Medical Center', 'role': 'CONTACT', 'email': 'knstar@hanmail.net', 'phone': '+82-2-6986-3307'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University Seoul Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ewha Womans University Mokdong Hospital', 'class': 'OTHER'}, {'name': 'National Rehabilitation Center, Seoul, Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tae-Jin Song, MD, PhD', 'investigatorAffiliation': 'Ewha Womans University Seoul Hospital'}}}}