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CompletedNCT05248295Updated May 18, 2025Results posted

Investigating the Effects of Rhythm and Entrainment on Fluency in People With Aphasia

An interventional study of Unison speech (vs. solo) and Metrical timing (vs. conversational) in Aphasia and Apraxia of Speech, sponsored by MGH Institute of Health Professions. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by MGH Institute of Health Professions · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Dec 2018, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Speaking in unison with another person is included as a part of many treatment approaches for aphasia. It is not well understood why and how this technique works. One goal of this study is to determine who benefits from speaking in unison, and what characteristics of speech are most helpful. Another goal is to investigate a possible mechanism for this benefit: why does speaking in unison help? A possible mechanism for this benefit is examined, by testing whether the degree of alignment of a person's speech with that of another speaker can account for unison benefit.

Read the detailed description

Aphasia is an acquired language disorder, most commonly due to stroke. It can affect an individual's ability to speak, understand spoken language, read, and write. Many treatments designed to improve spoken language in persons with aphasia (PWAs) use unison speech, having the person with aphasia speak along with the clinician or with a recording. One goal of this study is to determine who benefits from speaking in unison, and what characteristics of speech help them the most. Another goal is to investigate a possible mechanism for this benefit: why does speaking in unison help? This knowledge is important because understanding who benefits from this commonly used and potentially powerful therapy component, under which conditions they benefit, and why they do, is critical for customizing therapy so it can be as effective and efficient as possible. Unison speech is conducted using one of two different timing patterns: (1) a natural conversational pattern, which is used in everyday conversations, or (2) a metrical pattern, which follows a beat-based timing framework, as in songs or some poems. In either case, precisely aligning one's speech with that of another person (i.e., entraining one's speech) requires prediction: each speaker must plan their own speech motor commands before having heard the other speaker say the words they are planning. Natural conversational timing requires the speaker to make use of knowledge about language, particularly grammar, to align with the other person. In contrast, a metrical pattern allows a speaker to predict speech timing without relying heavily on language-based knowledge. Given that many PWAs have impaired grammar, we hypothesize that most PWAs will benefit more from speaking in unison to sentences with metrical vs. conversational timing patterns. However, there is great variation in linguistic, motor speech, and timing skills across PWAs, so metrical and conversational timing patterns are likely to have different degrees of effectiveness for different individuals. Results from this study will demonstrate how individual characteristics and speech timing affect whether or not a person with aphasia benefits from speaking in unison. Results will also indicate whether a speaker's ability to predict speech timing is necessary for a benefit of unison speech. Prediction ability will be measured by how closely the speaker aligns their speech with a spoken model.

02

Conditions studied

  • Aphasia
  • Apraxia of Speech

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03

In context

Aphasia

338 studies on the registry are indexed under Aphasia; 95 are open to participants now.

This study's enrollment of 75 is above the median of 30 across 298 interventional studies indexed under Aphasia.

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Lead sponsor

MGH Institute of Health Professions is the lead sponsor of 19 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Native-speaker fluency in American English (prior to stroke for people with aphasia)
  • Controls must report no history of speech, language, neurological disorders, or stroke
  • People with aphasia must be at least 6-months post-stroke, and aphasia must be due to stroke

Exclusion criteria

Exclusion Criteria:

  • Inadequate hearing ability to reliably complete task: fail hearing screen
  • Inadequate cognitive ability to understand and remember task: fail cognition screening (different measures for controls and people with aphasia)
  • Inadequate speech repetition ability to complete task, or to be considered a control: fail speech repetition screening (different thresholds for controls and people with aphasia)
  • Inadequate auditory comprehension ability to understand task: fail auditory comprehension screen (people with aphasia only)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    People with aphasia

    Adults with stroke-based aphasia. Designating this group as experimental reflects the focus on studying responses in people with aphasia. All participants will complete the same 4 study conditions in a 2x2 design (Unison vs. Solo and Metrical vs. Conversational).

    Behavioral: Unison speech (vs. solo) · Behavioral: Metrical timing (vs. conversational)

  • Other
    Healthy controls

    Adults without a history of speech, language, or neurological disorder, or stroke. This group is intended to serve as a context-providing reference group rather than a true comparator. All participants will complete the same 4 study conditions in a 2x2 design (Unison vs. Solo and Metrical vs. Conversational).

    Behavioral: Unison speech (vs. solo) · Behavioral: Metrical timing (vs. conversational)

Interventions

  • BehavioralUnison speech (vs. solo)

    Participants will repeat sentences in four conditions, in a 2x2 design with the factors unison vs. solo repetition, and metrical vs. conversational speech timing. Measures of speech accuracy and timing will be collected.

  • BehavioralMetrical timing (vs. conversational)

    This is the secondary contrast in the 2x2 design described above.

06

What researchers measure

Primary outcomes

  1. Percent Syllables Correct

    The percentage of syllables correctly repeated from the target sentences will be computed for each contrast, Unison vs. Solo and Metrical vs. Conversational, capturing all 4 conditions in the 2x2 design (Unison Metrical, Unison Conversational, Solo Metrical, Solo Conversational). A protocol will be used to score syllables for correctness.

    Time frame: 1 day study visit

Secondary outcomes

  1. Mean Syllable Offset From Model

    Of the syllables attempted by the participant, the mean offset from the corresponding target syllable in the model is computed for each syllable for each participant using the formula (p - d) - s, where p is the timing of voicing onset in the participant response, d is the timing of voicing onset in the model, and s is the line delay in the audio equipment. Means are computed for each participant and each condition. Note this measure can only be computed in the Unison conditions (Unison Metrical and Unison Conversational), since the Solo conditions do not have a simultaneous spoken model to which the participant is trying to align their speech.

    Time frame: 1 day study visit

07

Results

Posted May 18, 2025

Participant flow

Participant flow — Overall Study
MilestonePeople With AphasiaControls
Started2352
Completed1849
Not completed53
Withdrew: Found ineligible41
Withdrew: Withdrawal by subject01
Withdrew: Data loss: audio recording error11

Outcome measures

PrimaryPercent Syllables Correct

The percentage of syllables correctly repeated from the target sentences will be computed for each contrast, Unison vs. Solo and Metrical vs. Conversational, capturing all 4 conditions in the 2x2 design (Unison Metrical, Unison Conversational, Solo Metrical, Solo Conversational). A protocol will be used to score syllables for correctness.

Time frame:
1 day study visit
Reported as:
Mean · percentage
Percent Syllables Correct
percentageControlsPeople With Aphasia
Unison99.22 ± 1.0864.26 ± 23.13
Solo99.46 ± 1.1852.71 ± 33.57
Metrical99.65 ± 0.6760.47 ± 29.68
Conversational99.03 ± 1.3956.50 ± 28.98
Statistical analysis
  • People With Aphasia · Regression, Logistic · p = 0.077 (Results are reported for production condition for people with aphasia (experimental group).) · Odds ratio (or): 1.21OR computed with Unison as the numerator and Solo as the denominator
  • People With Aphasia · Regression, Logistic · p = >.1 (Results are reported for Timing Condition for the People with aphasia.)
  • People With Aphasia · Regression, Logistic · p = <0.001 · Odds ratio (or): 1.55OR computed as ((Unison Metrical)/(Unison Conversational)) / ((Solo Metrical)/(Solo Conversational))
  • Controls · Regression, Logistic · p = 0.036 (Results are reported for Production Condition for the Control group.) · Odds ratio (or): 0.63OR computed with Unison as the numerator and Solo as the denominator
  • Controls · Regression, Logistic · p = <0.001 · Odds ratio (or): 3.36OR computed with Metrical as the numerator and Conversational as the denominator
  • Controls · Regression, Logistic · p = >.1
SecondaryMean Syllable Offset From Model

Of the syllables attempted by the participant, the mean offset from the corresponding target syllable in the model is computed for each syllable for each participant using the formula (p - d) - s, where p is the timing of voicing onset in the participant response, d is the timing of voicing onset in the model, and s is the line delay in the audio equipment. Means are computed for each participant and each condition. Note this measure can only be computed in the Unison conditions (Unison Metrical and Unison Conversational), since the Solo conditions do not have a simultaneous spoken model to which the participant is trying to align their speech.

Time frame:
1 day study visit
Reported as:
Mean · seconds
Mean Syllable Offset From Model
secondsControlsPeople With Aphasia
Metrical-.016 ± .0280.030 ± 0.052
Conversational0.006 ± 0.0400.154 ± 0.188
Statistical analysis
  • People With Aphasia · Regression, Linear · p = <0.001 (Results are reported for people with aphasia (experimental group).) · Slope: -0.14
  • Controls · Regression, Linear · p = <0.001 (Results are reported for the Control group.) · Slope: -0.05

Adverse events

Collected over One study visit for controls and two study visits for people with aphasia, typically 1 day to 2 weeks apart. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention0/75 (0%)0/75 (0%)0/75 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)People With AphasiaControlsTotal
Mean59.0 ± 7.642.4 ± 18.447.5 ± 17.7
Sex: Female, Male
Sex: Female, Male(Participants)People With AphasiaControlsTotal
Female93140
Male142135
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)People With AphasiaControlsTotal
White, not Hispanic203656
White, Hispanic011
White, unknown ethnicity022
Black, not Hispanic358
Black, Hispanic000
Black, unknown ethnicity000
Asian, not Hispanic066
Asian, Hispanic011
Asian, ethnicity unknown000
race not specified, ethnicity unknown011
Hearing Screen
Hearing Screen(Participants)People With AphasiaControlsTotal
Count of participants225274
08

Study locations

1 site
  • MGH IHP
    Boston, Massachusetts 02129, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05248295
Lead sponsor
MGH Institute of Health Professions
Responsible party
Lauryn Zipse, Ph.D., CCC-SLP (Associate Professor, MGH Institute of Health Professions) — Principal investigator
First posted
Feb 21, 2022
Start date
Dec 4, 2018
Primary completion
Jun 28, 2023
Completion
Jun 28, 2023
Results posted
May 18, 2025
Last update
May 18, 2025

Study contacts

Lauryn Zipse, PhD
principal investigator · MGH IHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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