Trial Outcomes & Findings for Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia (NCT NCT01163461)

NCT ID: NCT01163461

Last Updated: 2017-08-31

Results Overview

percent change in the number of untrained words spoken correctly

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Baseline to one week post treatment termination and three months post treatment termination

Results posted on

2017-08-31

Participant Flow

Participant milestones

Participant milestones
Measure
Delayed Aphasia Therapy
14 individuals were randomized to received aphasia therapy following a 6-week control delay phase. Upon completion of the 6-week control phase, they received 60 hours of behavioral therapy
Immediate Aphasia Therapy
14 individuals were randomized to received 60 hours of aphasia therapy immediately following testing. (no delay)
Overall Study
STARTED
14
14
Overall Study
COMPLETED
14
14
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Behavioral Aphasia Therapy
n=28 Participants
Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
Age, Continuous
56 years
STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline to one week post treatment termination and three months post treatment termination

percent change in the number of untrained words spoken correctly

Outcome measures

Outcome measures
Measure
Behavioral Aphasia Therapy
n=28 Participants
Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
Speech Production
% change immediately post treatment
5.27 % change score of untrained real words
Standard Deviation 8.09
Speech Production
% change 3 months post treatment
5.28 % change score of untrained real words
Standard Deviation 7.55

Adverse Events

Single Group Open Trial

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Single Group Open Trial
n=28 participants at risk
28 individuals were randomized to receive either immediate speech therapy, or delayed speech therapy (following a 6 week delay period to control for Hawthorne effects). All participants received 60 hours of speech therapy 2 hours/day, 5 days/week for 6 weeks. Language behaviors were testing before, after and 3 months later.
Social circumstances
No adverse events
0.00%
0/28

Additional Information

Dr. Diane Kendall (PI)

VAMC Puget Sound

Phone: 206-762-1010

Results disclosure agreements

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