Trial Outcomes & Findings for Rhythm-based Intervention in Aphasia (NCT NCT04581564)
NCT ID: NCT04581564
Last Updated: 2025-07-14
Results Overview
Participants will be evaluated on practiced spoken words. The mean difference of practiced spoken words before and after the intervention will be calculated.
TERMINATED
NA
4 participants
10 weeks
2025-07-14
Participant Flow
The study was terminated early, before reaching the anticipated enrollment. All 4 participants enrolled were assigned to the Rhythm Intervention group.
Participant milestones
| Measure |
Rhythm Intervention
Practice speech production daily through rhythmic activity
Rhythm-based speech therapy app (i.e., Speech Hero): Patients with non-fluent aphasia will practice speech production during the intervention period.
|
Non-rhythm Intervention
Conventional speech production therapy without the use of rhythmic activities
Rhythm-based speech therapy app (i.e., Speech Hero): Patients with non-fluent aphasia will practice speech production during the intervention period.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data collected was not analyzed following the IRB termination of the study.
Baseline characteristics by cohort
| Measure |
Rhythm Intervention
n=4 Participants
Practice speech production daily through rhythmic activity
Rhythm-based speech therapy app (i.e., Speech Hero): Patients with non-fluent aphasia will practice speech production during the intervention period.
|
Non-rhythm Intervention
Conventional speech production therapy without the use of rhythmic activities
Rhythm-based speech therapy app (i.e., Speech Hero): Patients with non-fluent aphasia will practice speech production during the intervention period.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants • Data collected was not analyzed following the IRB termination of the study.
|
0 Participants
n=7 Participants • Data collected was not analyzed following the IRB termination of the study.
|
1 Participants
n=5 Participants • Data collected was not analyzed following the IRB termination of the study.
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants • Data collected was not analyzed following the IRB termination of the study.
|
0 Participants
n=7 Participants • Data collected was not analyzed following the IRB termination of the study.
|
3 Participants
n=5 Participants • Data collected was not analyzed following the IRB termination of the study.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: The study was terminated early, before reaching the anticipated enrollment. All 4 participants enrolled were assigned to the Rhythm Intervention group.
Participants will be evaluated on practiced spoken words. The mean difference of practiced spoken words before and after the intervention will be calculated.
Outcome measures
| Measure |
Rhythm Intervention
n=4 Participants
Practice speech production daily through rhythmic activity
Rhythm-based speech therapy app (i.e., Speech Hero): Patients with non-fluent aphasia will practice speech production during the intervention period.
|
Non-rhythm Intervention
Conventional speech production therapy without the use of rhythmic activities
Rhythm-based speech therapy app (i.e., Speech Hero): Patients with non-fluent aphasia will practice speech production during the intervention period.
|
|---|---|---|
|
Aphasia Spoken Word Assessment
|
1.5 Number of practiced spoken words
Standard Deviation 9.434
|
—
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: The study was terminated early, before reaching the anticipated enrollment. All 4 participants enrolled were assigned to the Rhythm Intervention group.
Participants' language ability will be assessed with Western Aphasia Battery (WAB), whose reliability and validity have been well established. The mean difference before and after the intervention will be calculated. The Aphasia Quotient is scored on a scale of 0-100. Lower scores represent more severe aphasia and higher scores represent lesser aphasia severity.
Outcome measures
| Measure |
Rhythm Intervention
n=4 Participants
Practice speech production daily through rhythmic activity
Rhythm-based speech therapy app (i.e., Speech Hero): Patients with non-fluent aphasia will practice speech production during the intervention period.
|
Non-rhythm Intervention
Conventional speech production therapy without the use of rhythmic activities
Rhythm-based speech therapy app (i.e., Speech Hero): Patients with non-fluent aphasia will practice speech production during the intervention period.
|
|---|---|---|
|
Western Aphasia Battery (WAB) Test
|
0.475 score on a scale
Standard Deviation 0.629
|
—
|
Adverse Events
Rhythm Intervention
Non-rhythm Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Yune Lee
Assistant Professor. Speech, Language and Hearing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place