Treatment Intensity - Apraxia of Speech

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02332915
• Collaborator: (none)
• Enrollment: 36
• Locations: 2
• Arms: 2
• Actual Duration (Months): 53.3
• Patients Per Site: 18
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

A growing neurorehabilitation literature suggests that intense treatment may be desired to maximize the effects of therapy following neurologic injury. This investigation is designed to facilitate the development of efficacious, clinically applicable treatment for acquired apraxia of speech by examining the effects of intensity of treatment (e.g., 9 hours per week vs. 3 hours per week, while holding total number of sessions constant) with a group of speakers who have chronic apraxia of speech and aphasia.

Condition or Disease	Intervention/Treatment	Phase
Aphasia; CVA; Apraxia of Speech	Behavioral: Sound Production Treatment (SPT)	N/A

Detailed Description

This research was designed to examine the effects of treatment intensity on outcomes associated with an established treatment for acquired apraxia of speech (AOS). Intensity in the form of dose frequency and total intervention duration was evaluated with Sound Production Treatment (SPT). The investigators examined the effects of intense dose frequency (nine, one-hour sessions per week) and traditional dose frequency (three, one hour sessions per week). Total number of treatment sessions was held constant allowing for comparison of total intervention duration (27 sessions over 3 weeks versus 27 sessions over 9 weeks). A two-phase, group cross-over design was used. Thirty-six participants with chronic aphasia and AOS were recruited. Twenty-four participants completed then entire study and were quasi-randomly assigned to one of two treatment groups - intense first or traditional first (12 per group). One group received SPT applied with intense dose frequency (SPT-I) followed by SPT applied with traditional dose frequency (SPT-T). The other group received the treatments in the reverse order (SPT-T followed by SPT-I). A two week no treatment interval separated the treatment phases. The outcomes of interest addressed changes in trained and untrained speech behaviors.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Intensity of Treatment on Rehabilitation of Acquired Apraxia of Speech
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: Oct 10, 2019
• Actual Study Completion Date: Oct 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPT - Intense First Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment Phase [Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase]

   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.

2. Accuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of Treatment Phase [Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase]

   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.

Secondary Outcome Measures

1. Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases [Pre treatment & 2 weeks following each 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Veterans and non Veterans

• Males or females

• Stroke survivor who is at least 4 months post-stroke

• Speaker of English since childhood

• Ability to pass a pure-tone hearing screening (aided or unaided)

• currently non-hospitalized

• Age 21 to 90 years

Exclusion Criteria:

• neurological condition other than stroke

• currently clinically depressed

• history of speech/language problems prior to stroke

• untreated psychopathology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania	United States	15240
2	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah	United States	84148

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Julie L Wambaugh, PhD, VA Salt Lake City Health Care System, Salt Lake City, UT

Study Documents (Full-Text)

• Study Protocol - Oct 3, 2020
• Statistical Analysis Plan - Oct 3, 2020

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02332915
• Other Study ID Numbers: C1782-R
• First Posted: Jan 7, 2015
• Last Update Posted: Jul 12, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: apraxia; aphasia; rehabilitation; efficacy; intensity
• Additional relevant MeSH terms: Aphasia; Apraxias

Study Results

Participant Flow

Arm/Group Title	SPT - Intense First	SPT - Traditional First
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	18	18
COMPLETED	12	12
NOT COMPLETED	6	6

Baseline Characteristics

Arm/Group Title	SPT - Intense First	SPT - Traditional First	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	12	12	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.75 (13.07)	61.83 (12.13)	58.79 (12.72)
Sex: Female, Male (Count of Participants)
Female	2 16.7%	5 41.7%	7 29.2%
Male	10 83.3%	7 58.3%	17 70.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 8.3%	1 4.2%
Not Hispanic or Latino	12 100%	11 91.7%	23 95.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 8.3%	1 4.2%
White	12 100%	11 91.7%	23 95.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Accuracy of Articulation of Treated Items in Baseline (Pre-treatment) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	12.03 (6.14)	10.5 (8.3)	11.28 (7.19)
Accuracy of Articulation of UNtreated Items in Baseline (Pre-treatment) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	14.07 (6.67)	13.9 (9.98)	13.99 (8.3)

Outcome Measures

1. Primary Outcome

Title	Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment Phase
Description	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.
Time Frame	Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SPT - Intense: All Participants	SPT - Traditional (Non-intense): All Participants
Arm/Group Description	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.	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.
Measure Participants	24	24
Mean (Standard Deviation) [effect sizes; magnitude of change]	19.7 (12.6)	28.9 (17.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SPT - Intense: All Participants, SPT - Traditional (Non-intense): All Participants
	Comments	Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for treated items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.0128
	Comments
	Method	t-test, 2 sided
	Comments	dependent t-test

2. Primary Outcome

Title	Accuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of Treatment Phase
Description	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.
Time Frame	Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase

Outcome Measure Data

Analysis Population Description

24 effect sizes from all 24 participants

Arm/Group Title	SPT - Intense; All Participants	SPT - Traditional; All Participants
Arm/Group Description	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.	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.
Measure Participants	24	24
Mean (Standard Deviation) [effect sizes; magnitude of change]	7.9 (5.6)	8.1 (8.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SPT - Intense: All Participants, SPT - Traditional (Non-intense): All Participants
	Comments	Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for untreated (generalization) items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.942
	Comments
	Method	t-test, 2 sided
	Comments	dependent t-test

3. Secondary Outcome

Title	Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases
Description	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.
Time Frame	Pre treatment & 2 weeks following each treatment phase

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Intense SPT First	Non-Intense (Traditional) SPT First	Both Arms Combined: Intense First + Traditional First
Arm/Group Description	Participants who received SPT Intense first, followed by a 2 week washout period and then received SPT-non-intense (SPT Traditional)	Participants who received non-intense SPT first, followed by a two week washout period, and then received intense SPT	All participants who received both treatment phases regardless of treatment order
Measure Participants	15	13	22
Baseline % Intelligibility	45.15 (33.9)	46.15 (29.5)	48.96 (31.92)
2 weeks Post Treatment #1: % Intelligibility	54.3 (37.2)	61.5 (30.5)	60.5 (33.1)
2 weeks Post Treatment #2: % Intelligibility	61.3 (34.9)	68.7 (30.5)	65 (32.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Both Arms Combined: Intense First + Traditional First
	Comments	Null Hypothesis: No difference in pre-treatment and post-treatment intelligibility scores
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Entire course of study which was approximately 26 weeks per participant: pretreatment/baseline period = 4 weeks + 3 weeks Treatment 1 + 2 weeks washout + 9 weeks Treatment 2 + follow-up at 2 and 8 weeks.
Adverse Event Reporting Description	All participants received two applications of SPT: intense application and non-intense (Traditional) application. Participants were grouped together for analyses by treatment type; this was due to the fact that all participants received both treatments and were observed in the same way for both treatments regardless of which treatment was received first. There were not adverse events and consequently, no need to examine adverse events by arm.
Arm/Group Title	SPT - Intense: All Participants		SPT - Traditional (Non-intense): All Participants
Arm/Group Description	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.		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.
All Cause Mortality
	SPT - Intense: All Participants		SPT - Traditional (Non-intense): All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Serious Adverse Events
	SPT - Intense: All Participants		SPT - Traditional (Non-intense): All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	SPT - Intense: All Participants		SPT - Traditional (Non-intense): All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.