AphasiaNCT02332915
Treatment Intensity - Apraxia of Speech
A study testing Sound Production Treatment (SPT) in people with Aphasia and CVA, run by VA Office of Research and Development at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Aphasia, CVA, Apraxia of Speech
- What is being tested?
- Sound Production Treatment (SPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2015to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- neurological condition other than stroke
- currently clinically depressed
- history of speech/language problems prior to stroke
- untreated psychopathology
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
About this study
Official title: Effect of Intensity of Treatment on Rehabilitation of Acquired Apraxia of Speech
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.
Read the 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.
- Conditions
- Aphasia, CVA, Apraxia of Speech
- Being tested
- Sound Production Treatment (SPT)
- Keywords
- apraxia, aphasia, rehabilitation, efficacy, intensity
- Medical subject headings
- Aphasia, Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound Production Treatment (SPT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SPT - Intense First | Experimental | Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment. Receives: Behavioral: Sound Production Treatment (SPT) |
| SPT - Traditional First | Experimental | Participants will receive non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment. Receives: Behavioral: Sound Production Treatment (SPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase
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.
Measured: Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase
Secondary outcomes (1)
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.
Measured: Pre treatment & 2 weeks following each treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study start1 May 2015
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie L Wambaugh, PhD, Principal investigator, VA Salt Lake City Health Care System, Salt Lake City, UT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332915
- Sponsor's protocol ID
- C1782-R
- Status last verified
- Mar 2022
- First submitted
- 22 Dec 2014
- Last updated
- 12 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the following will be shared for de-identified participants: Individual participant experimental stimuli will be provided in publications. Individual participant probe performance data will be shared in publications. Individual effect size data will be shared in publications. Individual pretreatment assessment performance will be shared in publications.
Publications
Wambaugh JL, Wright S, Boss E, Mauszycki SC, DeLong C, Hula W, Doyle PJ. Effects of Treatment Intensity on Outcomes in Acquired Apraxia of Speech. Am J Speech Lang Pathol. 2018 Mar 1;27(1S):306-322. doi: 10.1044/2017_AJSLP-16-0188.
PubMed 29497746Wambaugh JL, Wright S, Nessler C, Mauszycki SC, Bunker L, Boss E, Zhang Y, Hula WD, Doyle PJ. Further Study of the Effects of Treatment Intensity on Outcomes of Sound Production Treatment for Acquired Apraxia of Speech: Does Dose Frequency Matter? Am J Speech Lang Pathol. 2020 Feb 7;29(1):263-285. doi: 10.1044/2019_AJSLP-19-00005. Epub 2020 Feb 3.
PubMed 32011909
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensity of Treatment on Rehabilitation of Acquired Apraxia of Speech
- ClinicalTrials.gov ID
- NCT02332915
- Acronym / sponsor ID
- C1782-R
- Conditions
- Aphasia, CVA, Apraxia of Speech
- Keywords
- apraxia, aphasia, rehabilitation, efficacy, intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 May 2015 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Posted 17 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPT - Intense First | Experimental | Behavioral: Sound Production Treatment (SPT)Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment. |
| SPT - Traditional First | Experimental | Behavioral: Sound Production Treatment (SPT)Participants will receive non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- neurological condition other than stroke
- currently clinically depressed
- history of speech/language problems prior to stroke
- untreated psychopathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | SPT - Intense First, SPT - Traditional First |
Primary outcome
Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment Phase
Time frame: 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.
Accuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of Treatment Phase
Time frame: 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.
1 secondary outcome
Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases
Time frame: Pre treatment & 2 weeks following each treatment phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29497746Wambaugh JL, Wright S, Boss E, Mauszycki SC, DeLong C, Hula W, Doyle PJ. Effects of Treatment Intensity on Outcomes in Acquired Apraxia of Speech. Am J Speech Lang Pathol. 2018 Mar 1;27(1S):306-322. doi: 10.1044/2017_AJSLP-16-0188.
- Results publication: PubMed 32011909Wambaugh JL, Wright S, Nessler C, Mauszycki SC, Bunker L, Boss E, Zhang Y, Hula WD, Doyle PJ. Further Study of the Effects of Treatment Intensity on Outcomes of Sound Production Treatment for Acquired Apraxia of Speech: Does Dose Frequency Matter? Am J Speech Lang Pathol. 2020 Feb 7;29(1):263-285. doi: 10.1044/2019_AJSLP-19-00005. Epub 2020 Feb 3.
- Individual participant dataSharing planned: Yes. All of the following will be shared for de-identified participants: Individual participant experimental stimuli will be provided in publications. Individual participant probe performance data will be shared in publications. Individual effect size data will be shared in publications. Individual pretreatment assessment performance will be shared in publications.
Related trials for Aphasia
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Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
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Not yet recruiting
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Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie L Wambaugh, PhD principal investigator
VA Salt Lake City Health Care System, Salt Lake City, UT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound Production Treatment (SPT) in people with Aphasia and CVA, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment Phase (time frame: Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02332915, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.