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

35 years to 85 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
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

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

University of Leipzig

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.

General Publications

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

Keywords

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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