Trial Outcomes & Findings for Speech Therapy for Aphasia: Comparing Two Treatments (NCT NCT02153710)

NCT ID: NCT02153710

Last Updated: 2019-09-06

Results Overview

Reporting a change in percent correct scores pre-treatment versus 3-months post treatment. (0-100% scale)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: Pretreatment to 3 months following treatment termination change
• Results posted on: 2019-09-06

Participant Flow

Participant milestones

Measure	Phonomotor Therapy Experimental group Phonomotor Therapy: Experimental therapy.	Semantic Feature Analysis Therapy Current standard of care therapy Semantic Feature Analysis therapy: Control therapy; current standard of care therapy
Overall Study STARTED	28	30
Overall Study COMPLETED	28	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race was not collected from participants.

Baseline characteristics by cohort

Measure	Phonomotor Therapy n=28 Participants Experimental group Phonomotor Therapy: Experimental therapy.	Semantic Feature Analysis Therapy n=30 Participants Current standard of care therapy Semantic Feature Analysis therapy: Control therapy; current standard of care therapy	Total n=58 Participants Total of all reporting groups
Sex: Female, Male Female	13 Participants n=28 Participants	12 Participants n=30 Participants	25 Participants n=58 Participants
Sex: Female, Male Male	15 Participants n=28 Participants	18 Participants n=30 Participants	33 Participants n=58 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	—	0 Participants Race was not collected from participants.
Race (NIH/OMB) Asian	—	—	0 Participants Race was not collected from participants.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	0 Participants Race was not collected from participants.
Race (NIH/OMB) Black or African American	—	—	0 Participants Race was not collected from participants.
Race (NIH/OMB) White	—	—	0 Participants Race was not collected from participants.
Race (NIH/OMB) More than one race	—	—	0 Participants Race was not collected from participants.
Race (NIH/OMB) Unknown or Not Reported	—	—	0 Participants Race was not collected from participants.
Region of Enrollment United States	28 Participants n=28 Participants	30 Participants n=30 Participants	58 Participants n=58 Participants
Age, Continuous	63.3 years STANDARD_DEVIATION 10.6 • n=28 Participants	63.4 years STANDARD_DEVIATION 12.3 • n=30 Participants	63.35 years STANDARD_DEVIATION .070 • n=58 Participants

PRIMARY outcome

Timeframe: Pretreatment to 3 months following treatment termination change

Reporting a change in percent correct scores pre-treatment versus 3-months post treatment. (0-100% scale)

Outcome measures

Measure	Phonomotor Therapy n=28 Participants Experimental group Phonomotor Therapy: Experimental therapy.	Semantic Feature Analysis Therapy n=30 Participants Current standard of care therapy Semantic Feature Analysis therapy: Control therapy; current standard of care therapy
Spoken Word Production (Confrontation Naming)	53.01 percent correct Standard Deviation 29.71	50.37 percent correct Standard Deviation 29.79

SECONDARY outcome

Timeframe: Pretreatment to 3 months following treatment termination change

Change in response latency of confrontation naming pre-treatment versus 3 months post treatment.

Outcome measures

Measure	Phonomotor Therapy n=28 Participants Experimental group Phonomotor Therapy: Experimental therapy.	Semantic Feature Analysis Therapy n=30 Participants Current standard of care therapy Semantic Feature Analysis therapy: Control therapy; current standard of care therapy
Response Latency	1.49 seconds Standard Deviation 0.54	1.40 seconds Standard Deviation 0.67

SECONDARY outcome

Timeframe: Pretreatment to 3 months following treatment termination change

Change in confrontation naming of verbs were scored for accuracy and percent correct (0% to 100%) was analyzed before versus 3 months post treatment.

Outcome measures

Measure	Phonomotor Therapy n=28 Participants Experimental group Phonomotor Therapy: Experimental therapy.	Semantic Feature Analysis Therapy n=30 Participants Current standard of care therapy Semantic Feature Analysis therapy: Control therapy; current standard of care therapy
Verbs Correctly Named	3.36 percent correct Standard Deviation 7.19	2.46 percent correct Standard Deviation 9.11

Adverse Events

Phonomotor Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Semantic Feature Analysis 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

Diane Kendall

University of Washington

Phone: 2066160537

Email: dkendall@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place