Treatments of Acquired Apraxia of Speech

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01483807
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 77
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study was designed to examine the effects of speech therapy on ability to produce speech sounds in persons with acquired apraxia of speech.

Condition or Disease	Intervention/Treatment	Phase
Aphasia; Apraxia of Speech; Stroke	Behavioral: Sound Production Treatment - Blocked; Behavioral: Sound Production Treatment - Random	N/A

Detailed Description

This study was designed to investigate the effects of Sound Production Treatment (SPT; a treatment for acquired apraxia of speech) on sound production accuracy in persons with chronic apraxia of speech (AOS). Organization of practice (blocked practice or randomized practice) will be manipulated in an effort to determine the most efficacious application of SPT. A combination of group and single-subject experimental designs wasl be completed with 20 speakers with AOS (2 groups of 10 participants).

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Each participant received each arm of treatmentEach participant received each arm of treatment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatments of Acquired Apraxia of Speech
• Actual Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Sep 30, 2017
• Actual Study Completion Date: Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPT-B then SPT-R Participants first received Sound Production Treatment - Blocked (SPT-B) for 20 treatment sessions spanning approximately 7 weeks. After a washout period of 2 weeks, they then received Sound Production Treatment - Random (SPT-R) for 20 treatment sessions. Follow-up measures were conducted at 2, 6, and 10 weeks following the end of all treatment.	Behavioral: Sound Production Treatment - Blocked; Sound Production Treatment is a treatment for acquired apraxia of speech. Combines therapist modeling, simultaneous production, articulatory instruction, feedback and repeated practice. SPT-Blocked entailed practicing all treatment targets blocked by target. SPT-Random entailed practicing all treatment targets in a non predictable, random order.; Behavioral: Sound Production Treatment - Random; A treatment for acquired apraxia of speech. Combines therapist modeling, simultaneous production, articulatory instruction, feedback and repeated practice. SPT-Random entailed practicing treatment targets in a non predictable order. SPT-Blocked entailed practicing treatment targets blocked by target.
Experimental: SPT-R then SPT-B Participants first received Sound Production Treatment - Random (SPT-R) for 20 treatment sessions spanning approximately 7 weeks. After a washout period of 2 weeks, they then received Sound Production Treatment - Blocked (SPT-B) for 20 treatment sessions. Follow-up measures were conducted at 2, 6, and 10 weeks following the end of all treatment.	Behavioral: Sound Production Treatment - Blocked; Sound Production Treatment is a treatment for acquired apraxia of speech. Combines therapist modeling, simultaneous production, articulatory instruction, feedback and repeated practice. SPT-Blocked entailed practicing all treatment targets blocked by target. SPT-Random entailed practicing all treatment targets in a non predictable, random order.; Behavioral: Sound Production Treatment - Random; A treatment for acquired apraxia of speech. Combines therapist modeling, simultaneous production, articulatory instruction, feedback and repeated practice. SPT-Random entailed practicing treatment targets in a non predictable order. SPT-Blocked entailed practicing treatment targets blocked by target.

Outcome Measures

Primary Outcome Measures

1. Speech Production: Effect Size for Treated Items [Pre treatment (2-3 week period preceding the start of treatment) vs. 10 weeks post all treatment]

   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.

2. Speech Production: Percent Change in Treated Items [baseline to 10 weeks post 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).

Secondary Outcome Measures

1. Speech Production: Percent Change in Untrained Items [baseline to 10 weeks post treatment]

   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.

2. Speech Production of Untrained Items: Effect Sizes for Untrained Items [Baseline vs. 10 weeks post all treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must have acquired apraxia of speech that occurred following a stroke or other brain injury.

• Must be at least 6 months post-onset of brain injury.

• May have aphasia.

Exclusion Criteria:

• History of drug or alcohol abuse.

• History of mental illness.

• Neurological condition other than that which resulted in apraxia of speech.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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 - Nov 22, 2015
• Informed Consent Form - Nov 22, 2015
• Statistical Analysis Plan - Nov 22, 2015

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01483807
• Other Study ID Numbers: C7419-R
• First Posted: Dec 1, 2011
• Last Update Posted: Mar 22, 2019
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: speech; speech therapy; apraxia of speech
• Additional relevant MeSH terms: Aphasia; Apraxias

Study Results

Participant Flow

Pre-assignment Detail	Each participant received each treatment arm in this cross-over design. Order of treatment assignment was random.

Arm/Group Title	SPT-B Then SPT-R	SPT-R Then SPT-B
Arm/Group Description	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.	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.
Period Title: First Treatment Phase (7 Weeks)
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0
Period Title: First Treatment Phase (7 Weeks)
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0
Period Title: First Treatment Phase (7 Weeks)
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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.
Overall Participants	20
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55.5
Sex: Female, Male (Count of Participants)
Female	7 35%
Male	13 65%
Race/Ethnicity, Customized (Count of Participants)
Caucasian/non hispanic	20 100%
Region of Enrollment (Count of Participants)
United States	20 100%
Accuracy of Articulation (Count of Participants)
Count of Participants [Participants]	20 100%

Outcome Measures

1. Primary Outcome

Title	Speech Production: Effect Size for Treated Items
Description	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.
Time Frame	Pre treatment (2-3 week period preceding the start of treatment) vs. 10 weeks post all treatment

Outcome Measure Data

Analysis Population Description

20 speakers with chronic apraxia of speech and aphasia; effect sizes were calculated for each speaker for each treatment condition.

Arm/Group Title	SPT-R: All Participants	SPT-B: All Participants
Arm/Group Description	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.	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.
Measure Participants	20	20
Mean (Full Range) [effect size]	6.84	6.14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SPT-R: All Participants, SPT-B: All Participants
	Comments	Comparison of performance (change in articulation accuracy) with SPT-R versus SPT-B items. Based on the existing literature, it was predicted that the mean effect size associated with SPT-R would be greater than that for SPT-B.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.254
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.70
	Confidence Interval	(1-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Speech Production: Percent Change in Treated Items
Description	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).
Time Frame	baseline to 10 weeks post treatment

Outcome Measure Data

Analysis Population Description

20 speakers with chronic apraxia of speech and aphasia received both arms of treatment.

Arm/Group Title	SPT-R: All Participants	SPT-B: All Participants
Arm/Group Description	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.	All participants received SPT-R and SPT-B with order of treatments counterbalanced. Response to SPT-B is shown here.
Measure Participants	20	20
Mean (Full Range) [% change]	46	38

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SPT-R: All Participants, SPT-B: All Participants
	Comments	On the basis of existing literature. SPT-R was predicted to be associated with greater increase in articulatory accuracy over baseline levels than SPT-B.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.043
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.25
	Confidence Interval	(1-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Speech Production: Percent Change in Untrained Items
Description	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.
Time Frame	baseline to 10 weeks post treatment

Outcome Measure Data

Analysis Population Description

20 participants with chronic apraxia of speech and aphasia

Arm/Group Title	SPT-R: All Participants	SPT-B: All Participants
Arm/Group Description	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.	All participants received both SPT-R and SPT-B with order of treatments counterbalanced. Results for SPT-B are shown here.
Measure Participants	20	20
Mean (Full Range) [% change]	14	13

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SPT-R: All Participants, SPT-B: All Participants
	Comments	Comparison of change in accuracy of articulation of untreated items: SPT-R versus SPT-B items. It was predicted that there would be a greater increase in accuracy for SPT-R items.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.396
	Comments
	Method	t-test, 1 sided
	Comments

4. Secondary Outcome

Title	Speech Production of Untrained Items: Effect Sizes for Untrained Items
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 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.
Time Frame	Baseline vs. 10 weeks post all treatment

Outcome Measure Data

Analysis Population Description

20 speakers with chronic apraxia of speech and aphasia

Arm/Group Title	SPT-R: All Participants	SPT-B: All Participants
Arm/Group Description	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.	All participants received both SPT-R and SPT-B with order of treatments counterbalanced. SPT-B results are shown here.
Measure Participants	20	20
Mean (Full Range) [effect size]	2.56	2.11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SPT-R: All Participants, SPT-B: All Participants
	Comments	Comparison of effect sizes obtained for untreated SPT-R versus untreated SPT-B items. It was predicted that effect sizes would be greater for SPT-R untreated items.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.212
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Time Frame	Entire course of study which was approximately 30 weeks per participant: pretreatment/baseline period = 4 weeks + 7 weeks Treatment 1 + 2 weeks washout + 7 weeks Treatment 2 + follow-up at 10 weeks.
Arm/Group Title	All Participants
Arm/Group Description	All participants received Sound Production Treatment (SPT). Half of the participants received SPT administered in a blocked fashion (SPT-B) first, followed by a 2 week washout period, and then SPT administered in a random fashion (SPT-R). The other half of the participants received both treatments administered in the reverse order. 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.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

Two participants, one in each arm, received 10 sessions per phase rather than 20 sessions. This was due to these participants achieving high levels of accuracy very quickly; 20 sessions were not required (reduced burden).

More Information

Certain Agreements

All Principal Investigators ARE 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.