Working… Menu

Aphasia Therapy: Factors of Efficacy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02804412
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Information provided by (Responsible Party):
Hartwig Woldag, University of Leipzig

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.

Condition or disease Intervention/treatment Phase
Aphasia Other: Control group Other: CIAT-group Other: communication treatment group (CTG) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Constraint Induced Aphasia Therapy in Stroke Patients in Acute Stage.
Study Start Date : March 2005
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Active Comparator: Control group
Patients received a standard, house-typical aphasia therapy in single and group therapy sessions
Other: Control group
This is the control group with 14 h treatment over 10 workdays.

Experimental: CIAT-group
Patients received constraint-induced aphasia therapy.
Other: CIAT-group
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
Other: communication treatment group (CTG)
Examine the efficacy of CTG (30h over 10 wokrdays) versus CIAT-group and control group

Primary Outcome Measures :
  1. Change of aphasia by Aachener Aphasia Test (AAT) [ Time Frame: pretreatment and within 24 h post intervention ]

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   39 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02804412

Sponsors and Collaborators
University of Leipzig
Layout table for investigator information
Principal Investigator: Hartwig Woldag, PhD NRZ Leipzig
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hartwig Woldag, Head of departement NRZ Leipzig, University of Leipzig Identifier: NCT02804412    
Other Study ID Numbers: NRZ-CIAT
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hartwig Woldag, University of Leipzig:
communication disorders
language and speech disorder rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases