Trial Outcomes & Findings for Treatments of Acquired Apraxia of Speech (NCT NCT01483807)
NCT ID: NCT01483807
Last Updated: 2019-03-22
Results Overview
Change in accuracy of articulation of trained items as measured from baseline to 10 weeks post treatment using effect size calculations as the indicator of magnitude of change; production of words designated for treatment was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy calculated for each probe (maximum = 100%, minimum = 0% correct). Effect size calculations involved calculating the difference between post- and pre-treatment probe accuracy percentages with corrections made for variability (standard deviations in performance). The larger the effect size, the greater the change in performance from pre-treatment. Positive effect sizes = increases in accuracy \& negative effect sizes = decreases in accuracy.
COMPLETED
NA
20 participants
Pre treatment (2-3 week period preceding the start of treatment) vs. 10 weeks post all treatment
2019-03-22
Participant Flow
Each participant received each treatment arm in this cross-over design. Order of treatment assignment was random.
Participant milestones
| Measure |
SPT-B Then SPT-R
Participants in this arm received Sound Production Treatment - Blocked (SPT-B) for 20 treatment sessions. Following a 2 week washout period, participants received Sound Production Treatment - Random (SPT-R) for 20 treatment sessions. SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation ("watch me, listen to me, say it with me", articulation instruction, repeated practice and feedback. In the Blocked version, treatment targets are practiced by blocking items by sound target - words with the same target are grouped together. In the Random version, treatment targets are practiced in a non predictable order.
|
SPT-R Then SPT-B
Participants in this arm received Sound Production Treatment - Random (SPT-R) for 20 treatment sessions. Following a 2 week washout period, participants received Sound Production Treatment - Blocked (SPT-B) for 20 treatment sessions. SPT is a behavioral treatment that includes clinician modeling, orthographic cueing, integral stimulation ("watch me, listen to me, say it with me", articulation instruction, repeated practice and feedback. In the Blocked version, treatment targets are practiced by blocking items by sound target - words with the same target are grouped together. In the Random version, treatment targets are practiced in a non predictable order.
|
|---|---|---|
|
First Treatment Phase (7 Weeks)
STARTED
|
10
|
10
|
|
First Treatment Phase (7 Weeks)
COMPLETED
|
10
|
10
|
|
First Treatment Phase (7 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Washout (2 Weeks)
STARTED
|
10
|
10
|
|
Washout (2 Weeks)
COMPLETED
|
10
|
10
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Treatment Phase (7 Weeks)
STARTED
|
10
|
10
|
|
Second Treatment Phase (7 Weeks)
COMPLETED
|
10
|
10
|
|
Second Treatment Phase (7 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatments of Acquired Apraxia of Speech
Baseline characteristics by cohort
| Measure |
All Participants
n=20 Participants
All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a blocked fashion (SPT-B) first for 20 sessions. Following a 2 week washout period, those participants then received SPT applied in random fashion (SPT-R) for 20 sessions. The other half of the participants received the treatments in the opposite order.
|
|---|---|
|
Age, Continuous
|
55.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian/non hispanic
|
20 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
|
Accuracy of Articulation
|
20 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre treatment (2-3 week period preceding the start of treatment) vs. 10 weeks post all treatmentPopulation: 20 speakers with chronic apraxia of speech and aphasia; effect sizes were calculated for each speaker for each treatment condition.
Change in accuracy of articulation of trained items as measured from baseline to 10 weeks post treatment using effect size calculations as the indicator of magnitude of change; production of words designated for treatment was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy calculated for each probe (maximum = 100%, minimum = 0% correct). Effect size calculations involved calculating the difference between post- and pre-treatment probe accuracy percentages with corrections made for variability (standard deviations in performance). The larger the effect size, the greater the change in performance from pre-treatment. Positive effect sizes = increases in accuracy \& negative effect sizes = decreases in accuracy.
Outcome measures
| Measure |
SPT-R: All Participants
n=20 Participants
All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a blocked fashion (SPT-B) first for 20 sessions. Following a 2 week washout period, those participants then received SPT applied in random fashion (SPT-R) for 20 sessions. The other half of the participants received the treatments in the opposite order.All 20 administrations of SPT-R were analyzed relative to all 20 administrations of SPT-B.
|
SPT-B: All Participants
n=20 Participants
All 20 participants received both SPT-R and SPT-B, with order of administration of treatments being counterbalanced across participants. Data for SPT-B are shown here for all of the 20 participants.
|
|---|---|---|
|
Speech Production: Effect Size for Treated Items
|
6.84 effect size
Interval 1.66 to 18.78
|
6.14 effect size
Interval 0.83 to 14.38
|
PRIMARY outcome
Timeframe: baseline to 10 weeks post treatmentPopulation: 20 speakers with chronic apraxia of speech and aphasia received both arms of treatment.
Change in accuracy of articulation of treated items as measured by percent increase in accuracy above the highest baseline measurement; production of words designated for treatment was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy calculated for each probe (0% to 100% correct). The highest percentage accuracy achieved in pre-treatment probes was subtracted from the percentage accuracy achieved at 10 weeks post-treatment to obtain change in accuracy value - this reflects change from maximum correct performance in baseline (pre-treatment). e.g., if in baseline probes, performance ranged from 10% to 30% accuracy and at post treatment performance was 90% accuracy, the change value would be 60% (90% minus 30%). A greater change value indicates greater change in articulation/production of words. Change could be positive (improved articulation) or negative (poorer articulation).
Outcome measures
| Measure |
SPT-R: All Participants
n=20 Participants
All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a blocked fashion (SPT-B) first for 20 sessions. Following a 2 week washout period, those participants then received SPT applied in random fashion (SPT-R) for 20 sessions. The other half of the participants received the treatments in the opposite order.All 20 administrations of SPT-R were analyzed relative to all 20 administrations of SPT-B.
|
SPT-B: All Participants
n=20 Participants
All 20 participants received both SPT-R and SPT-B, with order of administration of treatments being counterbalanced across participants. Data for SPT-B are shown here for all of the 20 participants.
|
|---|---|---|
|
Speech Production: Percent Change in Treated Items
|
46 % change
Interval -20.0 to 100.0
|
38 % change
Interval -20.0 to 80.0
|
SECONDARY outcome
Timeframe: baseline to 10 weeks post treatmentPopulation: 20 participants with chronic apraxia of speech and aphasia
Percent change in articulatory accuracy of untrained items measured by change in percent accuracy over highest baseline value; production of words designated to NOT receive treatment (untrained items) was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy calculated for each probe (maximum = 100%, minimum = 0% correct). Effect size calculations involved calculating the difference between post- and pre-treatment probe accuracy percentages with corrections made for variability (standard deviations in performance). The larger the effect size, the greater the change in performance from pre-treatment. Positive effect sizes = increases in accuracy \& negative effect sizes = decreases in accuracy.
Outcome measures
| Measure |
SPT-R: All Participants
n=20 Participants
All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a blocked fashion (SPT-B) first for 20 sessions. Following a 2 week washout period, those participants then received SPT applied in random fashion (SPT-R) for 20 sessions. The other half of the participants received the treatments in the opposite order.All 20 administrations of SPT-R were analyzed relative to all 20 administrations of SPT-B.
|
SPT-B: All Participants
n=20 Participants
All 20 participants received both SPT-R and SPT-B, with order of administration of treatments being counterbalanced across participants. Data for SPT-B are shown here for all of the 20 participants.
|
|---|---|---|
|
Speech Production: Percent Change in Untrained Items
|
14 % change
Interval -60.0 to 100.0
|
13 % change
Interval -60.0 to 80.0
|
SECONDARY outcome
Timeframe: Baseline vs. 10 weeks post all treatmentPopulation: 20 speakers with chronic apraxia of speech and aphasia
Change in accuracy of articulation of untrained items as measured by effect sizes reflecting magnitude of change. Production of words designated to not receive treatment (i.e., generalization items) was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy calculated for each probe (0% to 100% correct). Change in accuracy of articulation of untrained items was measured from baseline to 10 weeks post treatment using effect size calculations as the indicator of magnitude of change. Effect size calculations involved calculating the difference between post- and pre-treatment probe accuracy percentages with corrections made for variability (standard deviations in performance). The larger the effect size, the greater the change in performance from pre-treatment.
Outcome measures
| Measure |
SPT-R: All Participants
n=20 Participants
All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a blocked fashion (SPT-B) first for 20 sessions. Following a 2 week washout period, those participants then received SPT applied in random fashion (SPT-R) for 20 sessions. The other half of the participants received the treatments in the opposite order.All 20 administrations of SPT-R were analyzed relative to all 20 administrations of SPT-B.
|
SPT-B: All Participants
n=20 Participants
All 20 participants received both SPT-R and SPT-B, with order of administration of treatments being counterbalanced across participants. Data for SPT-B are shown here for all of the 20 participants.
|
|---|---|---|
|
Speech Production of Untrained Items: Effect Sizes for Untrained Items
|
2.56 effect size
Interval -0.29 to 9.84
|
2.11 effect size
Interval -0.77 to 7.83
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place