- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02804412
Aphasia Therapy: Factors of Efficacy
June 14, 2016 updated by: Hartwig Woldag, University of Leipzig
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
37 years to 87 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- first ever stroke
- suffering from aphasia
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
Patients received a standard, house-typical aphasia therapy in single and group therapy sessions
|
This is the control group with 14 h treatment over 10 workdays.
|
Experimental: CIAT-group
Patients received constraint-induced aphasia therapy.
|
Examine the efficacy of CIAT (30 h over 10 workdays) versus Control-group and communication treatment group.
|
Active Comparator: communication treatment group (CTG)
Patients received aphasia group therapy without constraints
|
Examine the efficacy of CTG (30h over 10 wokrdays) versus CIAT-group and control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of aphasia by Aachener Aphasia Test (AAT)
Time Frame: pretreatment and within 24 h post intervention
|
pretreatment and within 24 h post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Communication Activity Log (CAL)
Time Frame: pretreatment and within 24 h post intervention
|
The CAL is a two-part questionnaire rating the amount and the quality of daily communication on a six-point scale
|
pretreatment and within 24 h post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hartwig Woldag, PhD, NRZ Leipzig
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
June 9, 2016
First Submitted That Met QC Criteria
June 14, 2016
First Posted (Estimate)
June 17, 2016
Study Record Updates
Last Update Posted (Estimate)
June 17, 2016
Last Update Submitted That Met QC Criteria
June 14, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NRZ-CIAT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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