Back to resultsAphasia Therapy: Factors of Efficacy
Primary Purpose
Aphasia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Control group
CIAT-group
communication treatment group (CTG)
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring communication disorders, language and speech disorder rehabilitation, stroke
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Control group
CIAT-group
communication treatment group (CTG)
Arm Description
Patients received a standard, house-typical aphasia therapy in single and group therapy sessions
Patients received constraint-induced aphasia therapy.
Patients received aphasia group therapy without constraints
Outcomes
Primary Outcome Measures
Change of aphasia by Aachener Aphasia Test (AAT)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02804412
Brief Title
Aphasia Therapy: Factors of Efficacy
Official Title
Constraint Induced Aphasia Therapy in Stroke Patients in Acute Stage.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
communication disorders, language and speech disorder rehabilitation, stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients received a standard, house-typical aphasia therapy in single and group therapy sessions
Arm Title
CIAT-group
Arm Type
Experimental
Arm Description
Patients received constraint-induced aphasia therapy.
Arm Title
communication treatment group (CTG)
Arm Type
Active Comparator
Arm Description
Patients received aphasia group therapy without constraints
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
This is the control group with 14 h treatment over 10 workdays.
Intervention Type
Other
Intervention Name(s)
CIAT-group
Intervention Description
Examine the efficacy of CIAT (30 h over 10 workdays) versus Control-group and communication treatment group.
Intervention Type
Other
Intervention Name(s)
communication treatment group (CTG)
Intervention Description
Examine the efficacy of CTG (30h over 10 wokrdays) versus CIAT-group and control group
Primary Outcome Measure Information:
Title
Change of aphasia by Aachener Aphasia Test (AAT)
Time Frame
pretreatment and within 24 h post intervention
Secondary Outcome Measure Information:
Title
Change of Communication Activity Log (CAL)
Description
The CAL is a two-part questionnaire rating the amount and the quality of daily communication on a six-point scale
Time Frame
pretreatment and within 24 h post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartwig Woldag, PhD
Organizational Affiliation
NRZ Leipzig
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27506677
Citation
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.
Results Reference
derived
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Aphasia Therapy: Factors of Efficacy
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