AphasiaMCIATNCT01625676
Study of Modified Constraint-Induced Aphasia Therapy Schedule to Treat Patients Following Sub-acute Stroke
A study testing Investigate efficacy of modified ciat schedule and examine the efficacy of standard treatment versus modified ciat schedule in people with Aphasia, run by NRZ Magdeburg Median Kliniken GmbH & Co at 1 site in Germany.
Trial summary
The purpose of this study is to assess the feasibility of modified Constraint-Induced Aphasia Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified CIAT versus standard treatment with the same intensity of intervention. Read more about this study
- Who is it for?
- Ages 34 to 84 years
- Conditions the study is for
- Aphasia
- What is being tested?
- Investigate efficacy of modified ciat schedule and examine the efficacy of standard treatment versus modified ciat schedule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2004to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 34 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of first-ever stroke
- aphasia in sub-acute stage
- german speakers
Who cannot join
- presence of residual aphasia
- dysarthria and apraxia of speech
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Constraint-Induced Aphasia Therapy Following Sub-acute Stroke: A Modified Therapy Schedule
The purpose of this study is to assess the feasibility of modified Constraint-Induced Aphasia Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified CIAT versus standard treatment with the same intensity of intervention.
- Conditions
- Aphasia
- Being tested
- Investigate efficacy of modified ciat schedule, examine the efficacy of standard treatment versus modified ciat schedule
- Keywords
- Aphasia, Rehabilitation of Speech and Language Disorders
- Medical subject headings
- Aphasia, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigate efficacy of modified ciat scheduleOther
2 hours of training over 15 days
examine the efficacy of standard treatment versus modified ciat scheduleOther
2 hours of training over 15 days
| Study group | Role | What they receive |
|---|---|---|
| CIAT-Group | Experimental | Patients received a modified constraint-induced therapy schedule Receives: Other: Investigate efficacy of modified ciat schedule |
| standard treatment group | Active comparator | patients received a standard aphasia therapy Receives: Other: examine the efficacy of standard treatment versus modified ciat schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT)
Measured: pretreatment and 4 weeks
change from pretreatment in Aachen Aphasia Test at 8 weeks
Measured: pretreatment and 8 weeks
change from pretreatment in Aachen Aphasia Test at 1 year
Measured: pretreatment and 1 year
Secondary outcomes (3)
Change of Communicative Activity (CAL)
Measured: pretreatment and 4 weeks
change from pretreatment in communication activity (CAL)at 8 weeks
Measured: pretreatment and 8 weeks
Change from pretreatment in communication activity (CAL)at 1 year
Measured: pretreatment and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startAug 2004
- Primary completionOct 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NRZ Magdeburg Median Kliniken GmbH & Co
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Almut A Sickert, PhD, Study chair, NRZ Median Klinik Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625676
- Sponsor's protocol ID
- SIC-2012
- Acronym
- MCIAT
- Status last verified
- Jun 2012
- First submitted
- 15 Jun 2012
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sickert A, Anders LC, Munte TF, Sailer M. Constraint-induced aphasia therapy following sub-acute stroke: a single-blind, randomised clinical trial of a modified therapy schedule. J Neurol Neurosurg Psychiatry. 2014 Jan;85(1):51-5. doi: 10.1136/jnnp-2012-304297. Epub 2013 Jul 4.
PubMed 23828834
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint-Induced Aphasia Therapy Following Sub-acute Stroke: A Modified Therapy Schedule
- ClinicalTrials.gov ID
- NCT01625676
- Acronym / sponsor ID
- MCIAT / SIC-2012
- Conditions
- Aphasia
- Keywords
- Aphasia, Rehabilitation of Speech and Language Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NRZ Magdeburg Median Kliniken GmbH & CoUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the feasibility of modified Constraint-Induced Aphasia Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified CIAT versus standard treatment with the same intensity of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIAT-Group | Experimental | Other: Investigate efficacy of modified ciat schedulePatients received a modified constraint-induced therapy schedule |
| standard treatment group | Active comparator | Other: examine the efficacy of standard treatment versus modified ciat schedulepatients received a standard aphasia therapy |
Who may qualify
- Ages
- 34 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of first-ever stroke
- aphasia in sub-acute stage
- german speakers
Key exclusion criteria (2 listed)
- presence of residual aphasia
- dysarthria and 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 |
|---|---|---|
| Investigate efficacy of modified ciat schedule2 hours of training over 15 days | Other | CIAT-Group |
| examine the efficacy of standard treatment versus modified ciat schedule2 hours of training over 15 days | Other | standard treatment group |
Primary outcome
Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT)
Time frame: pretreatment and 4 weeks
change from pretreatment in Aachen Aphasia Test at 8 weeks
Time frame: pretreatment and 8 weeks
change from pretreatment in Aachen Aphasia Test at 1 year
Time frame: pretreatment and 1 year
3 secondary outcomes
Change of Communicative Activity (CAL)
Time frame: pretreatment and 4 weeks
change from pretreatment in communication activity (CAL)at 8 weeks
Time frame: pretreatment and 8 weeks
Change from pretreatment in communication activity (CAL)at 1 year
Time frame: pretreatment and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
- Derived from this study: PubMed 23828834Sickert A, Anders LC, Munte TF, Sailer M. Constraint-induced aphasia therapy following sub-acute stroke: a single-blind, randomised clinical trial of a modified therapy schedule. J Neurol Neurosurg Psychiatry. 2014 Jan;85(1):51-5. doi: 10.1136/jnnp-2012-304297. Epub 2013 Jul 4.
Related trials for Aphasia
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Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
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Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
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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.
Almut A Sickert, PhD study chair
NRZ Median Klinik Magdeburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigate efficacy of modified ciat schedule and examine the efficacy of standard treatment versus modified ciat schedule in people with Aphasia, run by NRZ Magdeburg Median Kliniken GmbH & Co at 1 site in Germany.
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 2 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 21 Jun 2012. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT) (time frame: pretreatment and 4 weeks). The study lists 3 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 NCT01625676, which also lists 1 linked publication.
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 21 Jun 2012.