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
| 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
| 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 terminationpercent change in the number of untrained words spoken correctly
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place