Trial Outcomes & Findings for Investigating the Effects of Rhythm and Entrainment on Fluency in People With Aphasia (NCT NCT05248295)
NCT ID: NCT05248295
Last Updated: 2025-05-18
Results Overview
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.
COMPLETED
NA
75 participants
1 day study visit
2025-05-18
Participant Flow
Participant milestones
| Measure |
People With Aphasia
Adults with stroke-based aphasia
|
Controls
Adults without a history of speech, language, or neurological disorder, or stroke
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
52
|
|
Overall Study
COMPLETED
|
18
|
49
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
People With Aphasia
Adults with stroke-based aphasia
|
Controls
Adults without a history of speech, language, or neurological disorder, or stroke
|
|---|---|---|
|
Overall Study
found ineligible
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Data loss: audio recording error
|
1
|
1
|
Baseline Characteristics
Investigating the Effects of Rhythm and Entrainment on Fluency in People With Aphasia
Baseline characteristics by cohort
| Measure |
People With Aphasia
n=23 Participants
Adults with stroke-based aphasia
|
Controls
n=52 Participants
Adults without a history of speech, language, or neurological disorder, or stroke
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
42.4 years
STANDARD_DEVIATION 18.4 • n=107 Participants
|
47.5 years
STANDARD_DEVIATION 17.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, not Hispanic
|
20 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, Hispanic
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, unknown ethnicity
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black, not Hispanic
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black, Hispanic
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black, unknown ethnicity
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian, not Hispanic
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian, Hispanic
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian, ethnicity unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
race not specified, ethnicity unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Hearing Screen
|
22 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 day study visitThe 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.
Outcome measures
| Measure |
Controls
n=49 Participants
Adults without a history of speech, language, or neurological disorder, or stroke
|
People With Aphasia
n=18 Participants
Adults with stroke-based aphasia
|
|---|---|---|
|
Percent Syllables Correct
Unison
|
99.22 percentage
Standard Deviation 1.08
|
64.26 percentage
Standard Deviation 23.13
|
|
Percent Syllables Correct
Solo
|
99.46 percentage
Standard Deviation 1.18
|
52.71 percentage
Standard Deviation 33.57
|
|
Percent Syllables Correct
Metrical
|
99.65 percentage
Standard Deviation 0.67
|
60.47 percentage
Standard Deviation 29.68
|
|
Percent Syllables Correct
Conversational
|
99.03 percentage
Standard Deviation 1.39
|
56.50 percentage
Standard Deviation 28.98
|
SECONDARY outcome
Timeframe: 1 day study visitPopulation: Acoustic data were inadequate for 1 participant with aphasia (could not be reliably labeled due to vocal quality, resulting in too few data points for analysis for this participant).
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.
Outcome measures
| Measure |
Controls
n=49 Participants
Adults without a history of speech, language, or neurological disorder, or stroke
|
People With Aphasia
n=17 Participants
Adults with stroke-based aphasia
|
|---|---|---|
|
Mean Syllable Offset From Model
Metrical
|
-.016 seconds
Standard Deviation .028
|
0.030 seconds
Standard Deviation 0.052
|
|
Mean Syllable Offset From Model
Conversational
|
0.006 seconds
Standard Deviation 0.040
|
0.154 seconds
Standard Deviation 0.188
|
Adverse Events
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place