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Treatment Intensity - Apraxia of Speech

Effect of Intensity of Treatment on Rehabilitation of Acquired Apraxia of Speech

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02332915
Enrollment
36
Registered
2015-01-07
Start date
2015-05-01
Completion date
2019-10-10
Last updated
2022-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Apraxia of Speech, CVA

Keywords

apraxia, aphasia, rehabilitation, efficacy, intensity

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.

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.

Interventions

BEHAVIORALSound 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment PhasePre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phaseAccuracy 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.
Accuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of Treatment PhasePre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phaseChange 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

MeasureTime frameDescription
Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment PhasesPre treatment & 2 weeks following each treatment phaseMeasure 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
SPT - Intense First
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.
12
SPT - Traditional First
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.
12
Total24

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studydid not meet inclusion criteria24
Overall StudyMoved out of region30
Overall StudyTravel distance prohibitive01
Overall StudyUnrelated illness11

Baseline characteristics

CharacteristicSPT - Intense FirstTotalSPT - Traditional First
Accuracy of Articulation of Treated Items in Baseline (Pre-treatment)12.03 units on a scale
STANDARD_DEVIATION 6.14
11.28 units on a scale
STANDARD_DEVIATION 7.19
10.5 units on a scale
STANDARD_DEVIATION 8.3
Accuracy of Articulation of UNtreated Items in Baseline (Pre-treatment)14.07 units on a scale
STANDARD_DEVIATION 6.67
13.99 units on a scale
STANDARD_DEVIATION 8.3
13.9 units on a scale
STANDARD_DEVIATION 9.98
Age, Continuous55.75 years
STANDARD_DEVIATION 13.07
58.79 years
STANDARD_DEVIATION 12.72
61.83 years
STANDARD_DEVIATION 12.13
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants23 Participants11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
12 Participants23 Participants11 Participants
Sex: Female, Male
Female
2 Participants7 Participants5 Participants
Sex: Female, Male
Male
10 Participants17 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 24
other
Total, other adverse events
0 / 240 / 24
serious
Total, serious adverse events
0 / 240 / 24

Outcome results

Primary

Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of 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.

Time frame: Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase

ArmMeasureValue (MEAN)Dispersion
SPT - Intense: All ParticipantsAccuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment Phase19.7 effect sizes; magnitude of changeStandard Deviation 12.6
SPT - Traditional (Non-intense): All ParticipantsAccuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment Phase28.9 effect sizes; magnitude of changeStandard Deviation 17.2
Comparison: 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).p-value: 0.0128t-test, 2 sided
Primary

Accuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of 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.

Time frame: Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase

Population: 24 effect sizes from all 24 participants

ArmMeasureValue (MEAN)Dispersion
SPT - Intense: All ParticipantsAccuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of Treatment Phase7.9 effect sizes; magnitude of changeStandard Deviation 5.6
SPT - Traditional (Non-intense): All ParticipantsAccuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of Treatment Phase8.1 effect sizes; magnitude of changeStandard Deviation 8.9
Comparison: 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).p-value: 0.942t-test, 2 sided
Secondary

Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases

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

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

ArmMeasureGroupValue (MEAN)Dispersion
SPT - Intense: All ParticipantsSpeech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases2 weeks Post Treatment #2: % Intelligibility61.3 % Intelligible wordsStandard Deviation 34.9
SPT - Intense: All ParticipantsSpeech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases2 weeks Post Treatment #1: % Intelligibility54.3 % Intelligible wordsStandard Deviation 37.2
SPT - Intense: All ParticipantsSpeech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment PhasesBaseline % Intelligibility45.15 % Intelligible wordsStandard Deviation 33.9
SPT - Traditional (Non-intense): All ParticipantsSpeech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases2 weeks Post Treatment #2: % Intelligibility68.7 % Intelligible wordsStandard Deviation 30.5
SPT - Traditional (Non-intense): All ParticipantsSpeech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment PhasesBaseline % Intelligibility46.15 % Intelligible wordsStandard Deviation 29.5
SPT - Traditional (Non-intense): All ParticipantsSpeech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases2 weeks Post Treatment #1: % Intelligibility61.5 % Intelligible wordsStandard Deviation 30.5
Both Arms Combined: Intense First + Traditional FirstSpeech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases2 weeks Post Treatment #1: % Intelligibility60.5 % Intelligible wordsStandard Deviation 33.1
Both Arms Combined: Intense First + Traditional FirstSpeech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment PhasesBaseline % Intelligibility48.96 % Intelligible wordsStandard Deviation 31.92
Both Arms Combined: Intense First + Traditional FirstSpeech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases2 weeks Post Treatment #2: % Intelligibility65 % Intelligible wordsStandard Deviation 32.2
Comparison: Null Hypothesis: No difference in pre-treatment and post-treatment intelligibility scoresp-value: <0.001t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026