Speech Entrainment Treatment for People With Aphasia
Efficacy and Optimization of Speech Entrainment Practice for People With Aphasia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Speech entrainment refers to speaking in unison with a model speaker by imitating the model in real time. The objective of the study is to (1) experimentally establish the direct effect of speech entrainment practice on independent speech production post-treatment, and (2) identify conditions that enhance treatment benefits. These aims are addressed in a within-subject efficacy study, where 40 people with aphasia produce different stories with entrainment support. Speaking without entrainment is evaluated one day before and one day after speech entrainment practice. Different practice stories will be randomized within participants to three experimental conditions to assess the effect of treatment (trained vs. untrained), training schedule (massed vs. distributed presentation of stories), and entrainment modality (practice with auditory-only or audiovisual model). Correct information units per minute for each story will be tallied to evaluate the differences between conditions and the associations with patient characteristics. For consistency with prior research, number of different words per minute will serve as a secondary outcome. The proposed research addresses a clinical need by testing and optimizing a promising treatment technique for enhancing aphasia rehabilitation.
This proof-of-concept study is the first to evaluate the direct effect of speech entrainment practice on independent speech. Thus, the effect size for accurate power estimation is not known. The strategy for this study is to optimize experimental sensitivity by maximizing the number of observations per participants per condition within the constraints of feasibility. The results from this study will provide critical information for evaluating the effect size for a subsequent phase. Nevertheless, to estimate an optimal sample size, the investigators leveraged the data from our Pilot Study, which examines the speech entrainment effect on immediate performance rather than learning. With 13 participants, the investigators estimated 80% power to detect the effect of 0.8 (mean difference between groups divided by the pooled standard deviation) observed in our pilot study for speaking with audiovisual speech entrainment vs. independent speech (Aim 1). The calculation is based on a paired t-test with an alpha of .05 (two-tailed) and a correlation of 0.5 between groups. With 24 participants, there is 80% power to detect the observed effect of 0.6 for speaking with audiovisual speech entrainment vs. auditory-only speech entrainment (alpha is set to .05, two-tailed, correlation between groups is .57; Aim 2b). The investigators have substantially increased the sample size (N=40) with the consideration that learning effects (the focus of the present study) are expected to be smaller than performance effects (the focus of the Pilot Study).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Elkins Park, Pennsylvania, United States, 19027
- Moss Rehabilitation Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between 18-80 years at the time of enrollment
- English as native language
- greater than six months post onset
- Diagnosis of aphasia based on Western Aphasia Battery - Revised (WAB-R)
- Score of 7 or less on the Fluency subsection of the WAB-R
- Demonstrate having the willingness and stamina to participate in the multiple-session protocol, either by traveling to the MRRI testing site or being tested at home
Exclusion Criteria:
- History of learning disabilities
- History of other comorbid neurological impairments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Audiovisual Speech Entrainment Practice
Audiovisual Speech Entrainment includes repeated practice of speaking synchronously with a recorded model, which provides contextual, temporal, and audiovisual cues for speaking.
|
Speech Entrainment Practice is an aphasia rehabilitation treatment based on imitation of recorded speech in real time.
Treatment includes repeated practice of speaking along with a recorded model, which provides contextual, temporal, auditory, and visual cues for speaking
Speech Entrainment Practice is an aphasia rehabilitation treatment based on imitation of recorded speech in real time.
Treatment includes repeated practice of speaking along with a recorded model, which provides contextual, temporal, and auditory cues for speaking
|
|
Experimental: Auditory Speech Entrainment Practice
Auditory Speech Entrainment includes repeated practice of speaking synchronously with a recorded model, which provides contextual, temporal, and auditory cues for speaking.
|
Speech Entrainment Practice is an aphasia rehabilitation treatment based on imitation of recorded speech in real time.
Treatment includes repeated practice of speaking along with a recorded model, which provides contextual, temporal, auditory, and visual cues for speaking
Speech Entrainment Practice is an aphasia rehabilitation treatment based on imitation of recorded speech in real time.
Treatment includes repeated practice of speaking along with a recorded model, which provides contextual, temporal, and auditory cues for speaking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correct Information Units per Minute
Time Frame: one day post treatment
|
Correct Information Units per Minute will be tallied by blinded coders to measure the informativeness and efficacy of speech
|
one day post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Different Words per Minute
Time Frame: one day post treatment
|
Number of Different Words per Minute will be tallied by blinded coders to measure the amount and variability of speech
|
one day post treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marja-Liisa Mailend, PhD, Albert Einstein Healthcare Network
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 2020-386
- R21DC018893 (U.S. NIH Grant/Contract)
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
product manufactured in and exported from the U.S.
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