- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06213376
MIT Intensive Treatment Study (MITTXS)
Intensive MIT Paired With Video Feedback for Motor Speech Disorders and Aphasia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nevada
-
Henderson, Nevada, United States, 89002
- Nevada State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Fluent English speakers
- Sustained a left-hemisphere stroke
- Presents with language and motor speech impairments
Exclusion Criteria:
• History of learning disability prior to accident (per patient report)
- Uncorrected auditory or visual impairments
- Not meeting the criteria of stroke
- Failure to provide evidence of stroke diagnosis (medical record history)
- History of psychiatric disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
20 sessions/4 weeks: Video Feedback: S1) Participant (P1) views recording of previous session with the clinician & judges whether the production is intelligible. S2) S1 & the clinician identifies changes in motor movements that are influencing performance. S3+S4) S1+S2 & given support from the clinician, P1 identifies techniques improving intelligibility & modifies behavior accordingly. MIT: Humming - Clinician introduces the target phrase by showing a visual cue, humming the phrase, then intoning (singing) the phrase while P1 taps left-hand. Unison intoning - Clinician and P1 intone (sing) & tap the target phrase together. Unison intoning with fading - Clinician & P1 begin to intone (sing) & tap the target phrase together. The clinician fades out, while P1 continues to sing the rest of the phrase accompanied by tapping. Immediate repetition response to probe question - Following P1's successful repetition, the clinician intones a question and P1 intones the target. |
Melodic Intonation Therapy uses intonation and melody to aid individuals with aphasia with producing words.
Participant will view recording to judge correct and incorrect productions of trained words and to identify motor techniques increasing intelligibility
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intelligibility
Time Frame: From enrollment to 4 weeks post treatment
|
Intelligibility as measured by percentage of consonants correct and by targets produced on trained and untrained stimuli.
20 trained and 20 untrained speech phrases that are relevant to the client (measured during reading and repetition tasks)
|
From enrollment to 4 weeks post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Apraxia Battery for Adults
Time Frame: Baseline and one week following the end of treatment
|
A test to measure the presence and severity of apraxia in adults
|
Baseline and one week following the end of treatment
|
Assessment of Intelligibility of Dysarthria Speech
Time Frame: Baseline and one week following the end of treatment
|
A tool for quantifying single-word intelligibility, sentence intelligibility, and speaking rate of adult speakers with dysarthria
|
Baseline and one week following the end of treatment
|
Longer Connected Speech Assessment
Time Frame: Baseline and one and four weeks following the end of treatment
|
Change in Performance on Rainbow Passage- A public domain paragraph frequently used by speech-language pathologists to gather a speech sample of all phonemes for American English
|
Baseline and one and four weeks following the end of treatment
|
Quality of Life with Dysarthria (QOLdys)
Time Frame: Baseline and four weeks following treatments.
|
A reliable and valid tool to assess quality of life for patients with dysarthria.
|
Baseline and four weeks following treatments.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andre Lindsey, PhD, Nevada State University
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2312-0370
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 Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Melodic Intonation Therapy
-
Instituto de Investigación Hospital Universitario...CompletedPost Stroke Aphasia
-
The Hong Kong Polytechnic UniversitySuspended
-
Beth Israel Deaconess Medical CenterNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedStroke | Cerebral Infarction | Aphasia | Cerebrovascular Accident | ApoplexyUnited States
-
University GhentRecruitingGender DysphoriaBelgium
-
Loma Linda UniversityCompletedNonverbal and Low Verbal AutismUnited States
-
University of MiamiRecruiting
-
The University of Texas Health Science Center,...Completed
-
Bnai Zion Medical CenterUnknown
-
University of Alabama at BirminghamCompleted