Trial Outcomes & Findings for Treatment Intensity - Apraxia of Speech (NCT NCT02332915)

Last Updated: 2022-07-12

Results Overview

Accuracy of articulation of sounds in words, phrases, sentences designated for treatment. Assessed in nontreatment probes with productions elicited through repetition. Change in accuracy of articulation of trained items was measured from baseline to 2 weeks post treatment using effect size calculations as the indicator of magnitude of change. Percent accuracy was 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase

Results posted on

2022-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	SPT - Intense First Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.	SPT - Traditional First Participants will receive non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.
Overall Study STARTED	18	18
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	SPT - Intense First Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.	SPT - Traditional First Participants will receive non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.
Overall Study Moved out of region	3	0
Overall Study Unrelated illness	1	1
Overall Study Travel distance prohibitive	0	1
Overall Study did not meet inclusion criteria	2	4

Baseline Characteristics

Treatment Intensity - Apraxia of Speech

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SPT - Intense First n=12 Participants Participants received intense application in the first phase of treatment, followed by the non intense application of treatment. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy. Intense application = SPT-I: treatment administered for 3 hourly sessions per day, 3 days per week, for 3 weeks for a total of 27 hourly sessions.	SPT - Traditional First n=12 Participants Participants received non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy. Traditional application = SPT-T: treatment administered for 1 hourly session, 3 days per week for 9 weeks for a total of 27 hourly sessions.	Total n=24 Participants Total of all reporting groups
Age, Continuous	55.75 years STANDARD_DEVIATION 13.07 • n=93 Participants	61.83 years STANDARD_DEVIATION 12.13 • n=4 Participants	58.79 years STANDARD_DEVIATION 12.72 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	7 Participants n=4 Participants	17 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Accuracy of Articulation of Treated Items in Baseline (Pre-treatment)	12.03 units on a scale STANDARD_DEVIATION 6.14 • n=93 Participants	10.5 units on a scale STANDARD_DEVIATION 8.3 • n=4 Participants	11.28 units on a scale STANDARD_DEVIATION 7.19 • n=27 Participants
Accuracy of Articulation of UNtreated Items in Baseline (Pre-treatment)	14.07 units on a scale STANDARD_DEVIATION 6.67 • n=93 Participants	13.9 units on a scale STANDARD_DEVIATION 9.98 • n=4 Participants	13.99 units on a scale STANDARD_DEVIATION 8.3 • n=27 Participants

PRIMARY outcome

Timeframe: Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase

Outcome measures

Outcome measures
Measure	SPT - Intense: All Participants n=24 Participants All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in an intense manner (SPT-Intense; SPT-I) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in non-intense fashion (SPT-Traditional; SPT-T) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.	SPT - Traditional (Non-intense): All Participants n=24 Participants All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a non-intense manner (SPT- Traditional; SPT-T) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in an intense fashion (SPT-Intense; SPT-I) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.	Both Arms Combined: Intense First + Traditional First All participants who received both treatment phases regardless of treatment order
Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment Phase	19.7 effect sizes; magnitude of change Standard Deviation 12.6	28.9 effect sizes; magnitude of change Standard Deviation 17.2	—

PRIMARY outcome

Timeframe: Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase

Population: 24 effect sizes from all 24 participants

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 2 weeks post treatment with percent accuracy calculated for each probe (0% to 100% 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.

Outcome measures

Outcome measures
Measure	SPT - Intense: All Participants n=24 Participants All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in an intense manner (SPT-Intense; SPT-I) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in non-intense fashion (SPT-Traditional; SPT-T) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.	SPT - Traditional (Non-intense): All Participants n=24 Participants All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a non-intense manner (SPT- Traditional; SPT-T) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in an intense fashion (SPT-Intense; SPT-I) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.	Both Arms Combined: Intense First + Traditional First All participants who received both treatment phases regardless of treatment order
Accuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of Treatment Phase	7.9 effect sizes; magnitude of change Standard Deviation 5.6	8.1 effect sizes; magnitude of change Standard Deviation 8.9	—

SECONDARY outcome

Timeframe: Pre treatment & 2 weeks following each treatment phase

Population: Intense SPT First Arm: one participant's data was lost due to data storage problems \& three participants moved out of the region after the first treatment phase; Non-intense SPT First Arm: one participant's data was lost due to data storage problems \& one participant moved out of the region after the first treatment phase

Measure of how well an unfamiliar listener can understand speech. The Assessment of Intelligibility of Dysarthric Speech will be employed. The participant will repeat words which will be audiorecorded. A trained, but unfamiliar listener will orthographically transcribe the words that are produced. The transcriptions will be compared to the list of target (intended words) to determine a percentage of words that are correctly understood. The score may range from 0% to 100% of words understood.

Outcome measures

Outcome measures
Measure	SPT - Intense: All Participants n=15 Participants All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in an intense manner (SPT-Intense; SPT-I) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in non-intense fashion (SPT-Traditional; SPT-T) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.	SPT - Traditional (Non-intense): All Participants n=13 Participants All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a non-intense manner (SPT- Traditional; SPT-T) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in an intense fashion (SPT-Intense; SPT-I) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.	Both Arms Combined: Intense First + Traditional First n=22 Participants All participants who received both treatment phases regardless of treatment order
Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases Baseline % Intelligibility	45.15 % Intelligible words Standard Deviation 33.9	46.15 % Intelligible words Standard Deviation 29.5	48.96 % Intelligible words Standard Deviation 31.92
Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases 2 weeks Post Treatment #1: % Intelligibility	54.3 % Intelligible words Standard Deviation 37.2	61.5 % Intelligible words Standard Deviation 30.5	60.5 % Intelligible words Standard Deviation 33.1
Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases 2 weeks Post Treatment #2: % Intelligibility	61.3 % Intelligible words Standard Deviation 34.9	68.7 % Intelligible words Standard Deviation 30.5	65 % Intelligible words Standard Deviation 32.2

Adverse Events

SPT - Intense: All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SPT - Traditional (Non-intense): All Participants

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

Julie Wambaugh

University of Utah

Phone: 8015846164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place