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Speech Entrainment Treatment for People With Aphasia

Primary Purpose

Aphasia, Acquired

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audiovisual Speech Entrainment Practice
Auditory Speech Entrainment Practice
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia, Acquired

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moss Rehabilitation Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Audiovisual Speech Entrainment Practice

Auditory Speech Entrainment Practice

Arm Description

Audiovisual Speech Entrainment includes repeated practice of speaking synchronously with a recorded model, which provides contextual, temporal, and audiovisual cues for speaking.

Auditory Speech Entrainment includes repeated practice of speaking synchronously with a recorded model, which provides contextual, temporal, and auditory cues for speaking.

Outcomes

Primary Outcome Measures

Correct Information Units per Minute
Correct Information Units per Minute will be tallied by blinded coders to measure the informativeness and efficacy of speech

Secondary Outcome Measures

Number of Different Words per Minute
Number of Different Words per Minute will be tallied by blinded coders to measure the amount and variability of speech

Full Information

First Posted
January 9, 2023
Last Updated
March 27, 2023
Sponsor
Albert Einstein Healthcare Network
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT05687994
Brief Title
Speech Entrainment Treatment for People With Aphasia
Official Title
Efficacy and Optimization of Speech Entrainment Practice for People With Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Acquired

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Audiovisual Speech Entrainment Practice
Arm Type
Experimental
Arm Description
Audiovisual Speech Entrainment includes repeated practice of speaking synchronously with a recorded model, which provides contextual, temporal, and audiovisual cues for speaking.
Arm Title
Auditory Speech Entrainment Practice
Arm Type
Experimental
Arm Description
Auditory Speech Entrainment includes repeated practice of speaking synchronously with a recorded model, which provides contextual, temporal, and auditory cues for speaking.
Intervention Type
Behavioral
Intervention Name(s)
Audiovisual Speech Entrainment Practice
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Auditory Speech Entrainment Practice
Intervention Description
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
Primary Outcome Measure Information:
Title
Correct Information Units per Minute
Description
Correct Information Units per Minute will be tallied by blinded coders to measure the informativeness and efficacy of speech
Time Frame
one day post treatment
Secondary Outcome Measure Information:
Title
Number of Different Words per Minute
Description
Number of Different Words per Minute will be tallied by blinded coders to measure the amount and variability of speech
Time Frame
one day post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shauna Zodrow, BA
Phone
215-663-6107
Email
shauna.zodrow@jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marja-Liisa Mailend, PhD
Organizational Affiliation
Albert Einstein Healthcare Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moss Rehabilitation Research Institute
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shauna Zodrow
Phone
215-663-6107
Email
shauna.zodrow@jefferson.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Speech Entrainment Treatment for People With Aphasia

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