Aphasia, AcquiredNCT05687994
Speech Entrainment Treatment for People With Aphasia
A study testing Audiovisual Speech Entrainment Practice and Auditory Speech Entrainment Practice in people with Aphasia, Acquired, run by Albert Einstein Healthcare Network at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aphasia, Acquired
- What is being tested?
- Audiovisual Speech Entrainment Practice and Auditory Speech Entrainment Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2023to 29 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of learning disabilities
- History of other comorbid neurological impairments
Trial locations and contacts
1 site in 1 country.
United States1 site
Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, 19027
About this study
Official title: Efficacy and Optimization of Speech Entrainment Practice for People With Aphasia
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.
Read the 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).
- Conditions
- Aphasia, Acquired
- Being tested
- Audiovisual Speech Entrainment Practice, Auditory Speech Entrainment Practice
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual Speech Entrainment PracticeBehavioural
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
Auditory Speech Entrainment PracticeBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Audiovisual Speech Entrainment Practice | Experimental | Audiovisual Speech Entrainment includes repeated practice of speaking synchronously with a recorded model, which provides contextual, temporal, and audiovisual cues for speaking. Receives: Behavioral: Audiovisual Speech Entrainment Practice; Behavioral: Auditory Speech Entrainment Practice |
| Auditory Speech Entrainment Practice | Experimental | Auditory Speech Entrainment includes repeated practice of speaking synchronously with a recorded model, which provides contextual, temporal, and auditory cues for speaking. Receives: Behavioral: Audiovisual Speech Entrainment Practice; Behavioral: Auditory Speech Entrainment Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct Information Units per Minute
Correct Information Units per Minute will be tallied by blinded coders to measure the informativeness and efficacy of speech
Measured: one day post treatment
Secondary outcomes (1)
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
Measured: one day post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start25 Jan 2023
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Marja-Liisa Mailend, PhD, Albert Einstein Healthcare Network
- Investigators
- Marja-Liisa Mailend, PhD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687994
- Sponsor's protocol ID
- 2020-386
- Other IDs
- R21DC018893
- Status last verified
- Sep 2025
- First submitted
- 9 Jan 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Optimization of Speech Entrainment Practice for People With Aphasia
- ClinicalTrials.gov ID
- NCT05687994
- Acronym / sponsor ID
- 2020-386
- Conditions
- Aphasia, Acquired
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audiovisual Speech Entrainment Practice | Experimental | Behavioral: Audiovisual Speech Entrainment Practice, Behavioral: Auditory Speech Entrainment PracticeAudiovisual Speech Entrainment includes repeated practice of speaking synchronously with a recorded model, which provides contextual, temporal, and audiovisual cues for speaking. |
| Auditory Speech Entrainment Practice | Experimental | Behavioral: Audiovisual Speech Entrainment Practice, Behavioral: Auditory Speech Entrainment PracticeAuditory Speech Entrainment includes repeated practice of speaking synchronously with a recorded model, which provides contextual, temporal, and auditory cues for speaking. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- History of learning disabilities
- History of other comorbid neurological impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiovisual Speech Entrainment PracticeSpeech 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 | Behavioural | Audiovisual Speech Entrainment Practice, Auditory Speech Entrainment Practice |
| Auditory Speech Entrainment PracticeSpeech 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 | Behavioural | Audiovisual Speech Entrainment Practice, Auditory Speech Entrainment Practice |
Primary outcome
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
1 secondary outcome
Number of Different Words per Minute
Time frame: one day post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marja-Liisa Mailend, PhD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual Speech Entrainment Practice and Auditory Speech Entrainment Practice in people with Aphasia, Acquired, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct Information Units per Minute (time frame: one day post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.