Speech Entrainment Treatment for People With Aphasia

Status Recruiting

Clinical Trial Summary

The objective of this research is to experimentally delineate the direct effect of speech entrainment practice on independent speech production and identify practice conditions that enhance treatment benefits. The primary outcome measure (Correct Information Units per minute) tallies informativeness and efficiency of independent speech in treated stories.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05687994
Study type	Interventional
Source	Albert Einstein Healthcare Network
Contact	Shauna Zodrow, BA
Phone	215-663-6107
Email	shauna.zodrow@jefferson.edu
Status	Recruiting
Phase	N/A
Start date	January 25, 2023
Completion date	July 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.