AphasiaNCT02804412
Aphasia Therapy: Factors of Efficacy
A study testing CIAT-group and communication treatment group (CTG) in people with Aphasia, run by University of Leipzig.
Trial summary
Constraint-induced aphasia therapy (CIAT) has proven effective in stroke patients. It has remained unclear, however, whether intensity of therapy or constraint is the relevant factor. This study will give an answer to this question to improve speech and language therapy. Read more about this study
- Who is it for?
- Ages 39 to 89 years
- Conditions the study is for
- Aphasia
- What is being tested?
- CIAT-group and communication treatment group (CTG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Mar 2013
- 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 39 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first ever stroke
- suffering from aphasia
Who cannot join
- severe cognitive or attentional impairments
- severe depression
- left-handedness
- severe dysarthria
- apraxia of speech
- severe deafness
- additional neurological diseases affecting speech (e.g. Parkinson's disease)
About this study
Official title: Constraint Induced Aphasia Therapy in Stroke Patients in Acute Stage.
Constraint-induced aphasia therapy (CIAT) has proven effective in stroke patients. It has remained unclear, however, whether intensity of therapy or constraint is the relevant factor. This study will give an answer to this question to improve speech and language therapy.
Read the detailed description
Although there is clear evidence that aphasia therapy is effective, questions remain as to the intensity of administered therapy, the preferred therapeutic approach and its initiation with regard to stroke onset. CIAT is a a high intense group therapy administered over 2 weeks. Additionally, patients have to communicate solely in spoken words or sentences (constraint). This study compares CIAT with an approach of the same intensity without constraints and a less intense house-typical therapeutic approach.
- Conditions
- Aphasia
- Being tested
- Control group, CIAT-group, communication treatment group (CTG)
- Keywords
- communication disorders, language and speech disorder rehabilitation, stroke
- Medical subject headings
- Aphasia, Communication Disorders, Language, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
This is the control group with 14 h treatment over 10 workdays.
CIAT-groupOther
Examine the efficacy of CIAT (30 h over 10 workdays) versus Control-group and communication treatment group.
communication treatment group (CTG)Other
Examine the efficacy of CTG (30h over 10 wokrdays) versus CIAT-group and control group
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients received a standard, house-typical aphasia therapy in single and group therapy sessions Receives: Other: Control group |
| CIAT-group | Experimental | Patients received constraint-induced aphasia therapy. Receives: Other: CIAT-group |
| communication treatment group (CTG) | Active comparator | Patients received aphasia group therapy without constraints Receives: Other: communication treatment group (CTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of aphasia by Aachener Aphasia Test (AAT)
Measured: pretreatment and within 24 h post intervention
Secondary outcomes (1)
Change of Communication Activity Log (CAL)
The CAL is a two-part questionnaire rating the amount and the quality of daily communication on a six-point scale
Measured: pretreatment and within 24 h post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startMar 2005
- Primary completionJan 2013
- Study completionMar 2013
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hartwig Woldag, University of Leipzig
- Investigators
- Hartwig Woldag, PhD, Principal investigator, NRZ Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804412
- Sponsor's protocol ID
- NRZ-CIAT
- Status last verified
- Jun 2016
- First submitted
- 9 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Woldag H, Voigt N, Bley M, Hummelsheim H. Constraint-Induced Aphasia Therapy in the Acute Stage: What Is the Key Factor for Efficacy? A Randomized Controlled Study. Neurorehabil Neural Repair. 2017 Jan;31(1):72-80. doi: 10.1177/1545968316662707. Epub 2016 Aug 9.
PubMed 27506677
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint Induced Aphasia Therapy in Stroke Patients in Acute Stage.
- ClinicalTrials.gov ID
- NCT02804412
- Acronym / sponsor ID
- NRZ-CIAT
- Conditions
- Aphasia
- Keywords
- communication disorders, language and speech disorder rehabilitation, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Jun 2016 (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.
Constraint-induced aphasia therapy (CIAT) has proven effective in stroke patients. It has remained unclear, however, whether intensity of therapy or constraint is the relevant factor. This study will give an answer to this question to improve speech and language therapy.
Detailed description
Although there is clear evidence that aphasia therapy is effective, questions remain as to the intensity of administered therapy, the preferred therapeutic approach and its initiation with regard to stroke onset. CIAT is a a high intense group therapy administered over 2 weeks. Additionally, patients have to communicate solely in spoken words or sentences (constraint). This study compares CIAT with an approach of the same intensity without constraints and a less intense house-typical therapeutic approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Control groupPatients received a standard, house-typical aphasia therapy in single and group therapy sessions |
| CIAT-group | Experimental | Other: CIAT-groupPatients received constraint-induced aphasia therapy. |
| communication treatment group (CTG) | Active comparator | Other: communication treatment group (CTG)Patients received aphasia group therapy without constraints |
Who may qualify
- Ages
- 39 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- first ever stroke
- suffering from aphasia
Key exclusion criteria (7 listed)
- severe cognitive or attentional impairments
- severe depression
- left-handedness
- severe dysarthria
- 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 |
|---|---|---|
| Control groupThis is the control group with 14 h treatment over 10 workdays. | Other | Control group |
| CIAT-groupExamine the efficacy of CIAT (30 h over 10 workdays) versus Control-group and communication treatment group. | Other | CIAT-group |
| communication treatment group (CTG)Examine the efficacy of CTG (30h over 10 wokrdays) versus CIAT-group and control group | Other | communication treatment group (CTG) |
Primary outcome
Change of aphasia by Aachener Aphasia Test (AAT)
Time frame: pretreatment and within 24 h post intervention
1 secondary outcome
Change of Communication Activity Log (CAL)
Time frame: pretreatment and within 24 h post intervention
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 17 Jun 2016.
- Derived from this study: PubMed 27506677Woldag H, Voigt N, Bley M, Hummelsheim H. Constraint-Induced Aphasia Therapy in the Acute Stage: What Is the Key Factor for Efficacy? A Randomized Controlled Study. Neurorehabil Neural Repair. 2017 Jan;31(1):72-80. doi: 10.1177/1545968316662707. Epub 2016 Aug 9.
- Individual participant dataSharing planned: No
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
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
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.
Hartwig Woldag, PhD principal investigator
NRZ Leipzig
Questions about this trial
What is this clinical trial studying?
A study testing CIAT-group and communication treatment group (CTG) in people with Aphasia, run by University of Leipzig.
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 2 inclusion and 7 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 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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 by Aachener Aphasia Test (AAT) (time frame: pretreatment and within 24 h post intervention). 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 NCT02804412, 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 17 Jun 2016.