AphasiaApraxiaNCT01483807

Treatments of Acquired Apraxia of Speech

A study testing Sound Production Treatment - Blocked and Sound Production Treatment - Random in people with Aphasia and Apraxia of Speech, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 85 years
Conditions the study is for: Aphasia, Apraxia of Speech, Stroke
What is being tested?: Sound Production Treatment - Blocked and Sound Production Treatment - Random
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2011to 31 Dec 2017
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

History of drug or alcohol abuse.
History of mental illness.
Neurological condition other than that which resulted in apraxia of speech.

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148

Other trials in United States

About this study

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

Read the 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).

Conditions: Aphasia, Apraxia of Speech, Stroke
Being tested: Sound Production Treatment - Blocked, Sound Production Treatment - Random
Keywords: speech, speech therapy, apraxia of speech
Medical subject headings: Aphasia, Apraxias, Stroke, Speech, Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sound Production Treatment - BlockedBehavioural
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.
Sound Production Treatment - RandomBehavioural
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.

Study groups in NCT01483807
Study group	Role	What they receive
SPT-B then SPT-R	Experimental	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. Receives: Behavioral: Sound Production Treatment - Blocked; Behavioral: Sound Production Treatment - Random
SPT-R then SPT-B	Experimental	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. Receives: Behavioral: Sound Production Treatment - Blocked; Behavioral: Sound Production Treatment - Random

What is being measured

The primary outcome is the main question the study is designed to answer.

Speech Production: Effect Size for Treated Items
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.
Measured: Pre treatment (2-3 week period preceding the start of treatment) vs. 10 weeks post all treatment
Speech Production: Percent Change in Treated Items
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).
Measured: baseline to 10 weeks post treatment

Secondary outcomes (2)

Speech Production: Percent Change in Untrained Items
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.
Measured: baseline to 10 weeks post treatment
Speech Production of Untrained Items: Effect Sizes for Untrained Items
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.
Measured: Baseline vs. 10 weeks post all treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201131 Dec 2017

First posted1 Dec 2011 (estimated)
Study start1 Aug 2011
Primary completion30 Sep 2017
Study completion31 Dec 2017

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 (8)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: Non-randomised
Intervention model: Crossover
Model description: Each participant received each arm of treatment
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01483807
Sponsor's protocol ID: C7419-R
Acronym: Apraxia
Status last verified: Dec 2018
First submitted: 15 Apr 2011
Last updated: 22 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Wambaugh JL, Nessler C, Cameron R, Mauszycki SC. Treatment for acquired apraxia of speech: examination of treatment intensity and practice schedule. Am J Speech Lang Pathol. 2013 Feb;22(1):84-102. doi: 10.1044/1058-0360(2012/12-0025). Epub 2012 Oct 15.
PubMed 23071199
Wambaugh J, Shuster L, Bailey DJ, Mauszycki S, Kean J, Nessler C, Wright S, Brunsvold J. Self-Judgments of Word Production Accuracy in Acquired Apraxia of Speech. Am J Speech Lang Pathol. 2016 Dec 1;25(4S):S716-S728. doi: 10.1044/2016_AJSLP-15-0139.
PubMed 27997948
Bailey DJ, Eatchel K, Wambaugh J. Sound Production Treatment: Synthesis and Quantification of Outcomes. Am J Speech Lang Pathol. 2015 Nov;24(4):S798-814. doi: 10.1044/2015_AJSLP-14-0127.
PubMed 26133692
Wambaugh JL, Nessler C, Wright S, Mauszycki SC, DeLong C, Berggren K, Bailey DJ. Effects of Blocked and Random Practice Schedule on Outcomes of Sound Production Treatment for Acquired Apraxia of Speech: Results of a Group Investigation. J Speech Lang Hear Res. 2017 Jun 22;60(6S):1739-1751. doi: 10.1044/2017_JSLHR-S-16-0249.
PubMed 28655045
Mauszycki SC, Bailey DJ, Wambaugh JL. Acquired Apraxia of Speech: The Relationship Between Awareness of Errors in Word Productions and Treatment Outcomes. Am J Speech Lang Pathol. 2017 Jun 22;26(2S):664-673. doi: 10.1044/2017_AJSLP-16-0111.
PubMed 28654947
Wambaugh J, Nessler C, Wright S, Mauszycki S, DeLong C. Sound production treatment for acquired apraxia of speech: Effects of blocked and random practice on multisyllabic word production. Int J Speech Lang Pathol. 2016 Oct;18(5):450-64. doi: 10.3109/17549507.2015.1101161. Epub 2015 Nov 9.
PubMed 27063676
Wambaugh JL, Nessler C, Wright S, Mauszycki SC. Sound production treatment: effects of blocked and random practice. Am J Speech Lang Pathol. 2014 May;23(2):S225-45. doi: 10.1044/2014_AJSLP-13-0072.
PubMed 24687207
DeLong C, Nessler C, Wright S, Wambaugh J. Semantic Feature Analysis: Further Examination of Outcomes. Am J Speech Lang Pathol. 2015 Nov;24(4):S864-79. doi: 10.1044/2015_AJSLP-14-0155.
PubMed 26384102

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
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Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke

All Aphasia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatments of Acquired Apraxia of Speech
ClinicalTrials.gov ID: NCT01483807
Acronym / sponsor ID: Apraxia / C7419-R
Conditions: Aphasia, Apraxia of Speech, Stroke
Keywords: speech, speech therapy, apraxia of speech
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Aug 2011 (actual)
Primary completion: 30 Sep 2017 (actual)
Study completion: 31 Dec 2017 (actual)
First posted: 1 Dec 2011 (estimated)
Results: Posted 22 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Each participant received each arm of treatment

Arm	Type	Receives
SPT-B then SPT-R	Experimental	Behavioral: Sound Production Treatment - Blocked, Behavioral: Sound Production Treatment - RandomParticipants 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.
SPT-R then SPT-B	Experimental	Behavioral: Sound Production Treatment - Blocked, Behavioral: Sound Production Treatment - RandomParticipants 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.

Who may qualify

Ages: 21 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

History of drug or alcohol abuse.
History of mental illness.
Neurological condition other than that which resulted in apraxia of speech.

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 - BlockedSound 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.	Behavioural	SPT-B then SPT-R, SPT-R then SPT-B
Sound Production Treatment - RandomA 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.	Behavioural	SPT-B then SPT-R, SPT-R then SPT-B

Primary outcome

Speech Production: Effect Size for Treated Items
Time frame: 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.
Speech Production: Percent Change in Treated Items
Time frame: 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).

2 secondary outcomes

Speech Production: Percent Change in Untrained Items
Time frame: baseline to 10 weeks post treatment
Speech Production of Untrained Items: Effect Sizes for Untrained Items
Time frame: Baseline vs. 10 weeks post all treatment

Results and safety

Results posted to the registry on 22 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SPT-B Then SPT-R	10	10
SPT-R Then SPT-B	10	10

Primary outcome: Speech Production: Effect Size for Treated Items

Time frame: Pre treatment (2-3 week period preceding the start of treatment) vs. 10 weeks post all treatment. Mean (Full Range). Unit: effect size

Measure	SPT-R: All Participants n = 20	SPT-B: All Participants n = 20
Value	6.84 (1.66 to 18.78)	6.14 (.83 to 14.38)

SPT-R: All Participants vs SPT-B: All Participants: Mean Difference (Final Values): .70, p = .254, t-test, 1 sided

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

Primary outcome: Speech Production: Percent Change in Treated Items

Time frame: baseline to 10 weeks post treatment. Mean (Full Range). Unit: % change

Measure	SPT-R: All Participants n = 20	SPT-B: All Participants n = 20
Value	46 (-20 to 100)	38 (-20 to 80)

SPT-R: All Participants vs SPT-B: All Participants: Mean Difference (Final Values): 8.25, p = .043, t-test, 1 sided

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

2 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23071199Wambaugh JL, Nessler C, Cameron R, Mauszycki SC. Treatment for acquired apraxia of speech: examination of treatment intensity and practice schedule. Am J Speech Lang Pathol. 2013 Feb;22(1):84-102. doi: 10.1044/1058-0360(2012/12-0025). Epub 2012 Oct 15.
Results publication: PubMed 27997948Wambaugh J, Shuster L, Bailey DJ, Mauszycki S, Kean J, Nessler C, Wright S, Brunsvold J. Self-Judgments of Word Production Accuracy in Acquired Apraxia of Speech. Am J Speech Lang Pathol. 2016 Dec 1;25(4S):S716-S728. doi: 10.1044/2016_AJSLP-15-0139.
Results publication: PubMed 26133692Bailey DJ, Eatchel K, Wambaugh J. Sound Production Treatment: Synthesis and Quantification of Outcomes. Am J Speech Lang Pathol. 2015 Nov;24(4):S798-814. doi: 10.1044/2015_AJSLP-14-0127.
Results publication: PubMed 28655045Wambaugh JL, Nessler C, Wright S, Mauszycki SC, DeLong C, Berggren K, Bailey DJ. Effects of Blocked and Random Practice Schedule on Outcomes of Sound Production Treatment for Acquired Apraxia of Speech: Results of a Group Investigation. J Speech Lang Hear Res. 2017 Jun 22;60(6S):1739-1751. doi: 10.1044/2017_JSLHR-S-16-0249.
Results publication: PubMed 28654947Mauszycki SC, Bailey DJ, Wambaugh JL. Acquired Apraxia of Speech: The Relationship Between Awareness of Errors in Word Productions and Treatment Outcomes. Am J Speech Lang Pathol. 2017 Jun 22;26(2S):664-673. doi: 10.1044/2017_AJSLP-16-0111.
Results publication: PubMed 27063676Wambaugh J, Nessler C, Wright S, Mauszycki S, DeLong C. Sound production treatment for acquired apraxia of speech: Effects of blocked and random practice on multisyllabic word production. Int J Speech Lang Pathol. 2016 Oct;18(5):450-64. doi: 10.3109/17549507.2015.1101161. Epub 2015 Nov 9.
Results publication: PubMed 24687207Wambaugh JL, Nessler C, Wright S, Mauszycki SC. Sound production treatment: effects of blocked and random practice. Am J Speech Lang Pathol. 2014 May;23(2):S225-45. doi: 10.1044/2014_AJSLP-13-0072.
Derived from this study: PubMed 26384102DeLong C, Nessler C, Wright S, Wambaugh J. Semantic Feature Analysis: Further Examination of Outcomes. Am J Speech Lang Pathol. 2015 Nov;24(4):S864-79. doi: 10.1044/2015_AJSLP-14-0155.
Individual participant dataSharing planned: Undecided

Related trials for Aphasia

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Not yet recruitingObservational study
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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 3 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 22 Mar 2019). 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?

Speech Production: Effect Size for Treated Items (time frame: Pre treatment (2-3 week period preceding the start of treatment) vs. 10 weeks post all treatment). 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 NCT01483807, which also lists 8 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 22 Mar 2019.