Trial Outcomes & Findings for Speech Hero Home Therapy for Aphasia (NCT NCT04471935)

Results Overview

Number of participants able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues. Speech Hero will be deemed feasible for this population if at least 5 participants are able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Immediately Post-Treatment, an average of 4 weeks

Results posted on

2022-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	At Home Speech Hero Therapy At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	At Home Speech Hero Therapy At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period.
Overall Study Withdrawal by Subject	1
Overall Study Deemed ineligible to participate	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	At Home Speech Hero Therapy n=8 Participants At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period.
Age, Categorical <=18 years	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=8 Participants
Age, Categorical >=65 years	2 Participants n=8 Participants
Age, Continuous	47 years STANDARD_DEVIATION 19 • n=8 Participants
Sex: Female, Male Female	2 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=8 Participants
Region of Enrollment United States	8 participants n=8 Participants

PRIMARY outcome

Timeframe: Immediately Post-Treatment, an average of 4 weeks

Number of participants able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues. Speech Hero will be deemed feasible for this population if at least 5 participants are able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues.

Outcome measures

Outcome measures
Measure	At Home Speech Hero Therapy n=8 Participants At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for at least 10 hours over a 4-week period.
Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks	7 Participants

SECONDARY outcome

Timeframe: Immediately Post-Treatment, an average of 4 weeks

Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. The Western Aphasia Battery (WAB) is comprised of 8 subscales. For this study the subscales of spontaneous speech, auditory verbal comprehension, repetition, naming and word finding were used. Results reported as change in score from baseline to post-treatment (each subscale score is on 0-100% scale with higher score representing less impairment).

Outcome measures

Outcome measures
Measure	At Home Speech Hero Therapy n=8 Participants At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for at least 10 hours over a 4-week period.
Change in Score on Western Aphasia Battery Spontaneous Speech	3 score on a scale Standard Deviation 7
Change in Score on Western Aphasia Battery Auditory Verbal Comprehension	-1 score on a scale Standard Deviation 7
Change in Score on Western Aphasia Battery Repetition	2 score on a scale Standard Deviation 10
Change in Score on Western Aphasia Battery Naming and Word Finding	6 score on a scale Standard Deviation 4

SECONDARY outcome

Timeframe: Immediately Post-Treatment, an average of 4 weeks

Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cueing and after semantic cueing. Results reported as change in score from baseline to post-treatment (score for Boston Naming Test (BNT) is on 0-100% scale with higher score representing less impairment).

Outcome measures

Outcome measures
Measure	At Home Speech Hero Therapy n=8 Participants At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for at least 10 hours over a 4-week period.
Change in Score on Boston Naming Test	5 score on a scale Standard Deviation 9

Adverse Events

At Home Speech Hero Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ian Russell

Flint Rehabilitation Devices

Phone: 3392232676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place