Study of Modified Constraint-Induced Aphasia Therapy Schedule to Treat Patients Following Sub-acute Stroke (MCIAT)

June 19, 2012 updated by: NRZ Magdeburg Median Kliniken GmbH & Co

Constraint-Induced Aphasia Therapy Following Sub-acute Stroke: A Modified Therapy Schedule

The purpose of this study is to assess the feasibility of modified Constraint-Induced Aphasia Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified CIAT versus standard treatment with the same intensity of intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Magdeburg, Germany, 39120
        • NRZ Median Klinik

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

34 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of first-ever stroke
  • aphasia in sub-acute stage
  • german speakers

Exclusion Criteria:

  • presence of residual aphasia
  • dysarthria and apraxia of speech

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
Experimental: CIAT-Group
Patients received a modified constraint-induced therapy schedule
Other: Investigate efficacy of modified ciat schedule
2 hours of training over 15 days
Active Comparator: standard treatment group
patients received a standard aphasia therapy
Other: examine the efficacy of standard treatment versus modified ciat schedule
2 hours of training over 15 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT)
Time Frame: pretreatment and 4 weeks
pretreatment and 4 weeks
change from pretreatment in Aachen Aphasia Test at 8 weeks
Time Frame: pretreatment and 8 weeks
pretreatment and 8 weeks
change from pretreatment in Aachen Aphasia Test at 1 year
Time Frame: pretreatment and 1 year
pretreatment and 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Communicative Activity (CAL)
Time Frame: pretreatment and 4 weeks
pretreatment and 4 weeks
change from pretreatment in communication activity (CAL)at 8 weeks
Time Frame: pretreatment and 8 weeks
pretreatment and 8 weeks
Change from pretreatment in communication activity (CAL)at 1 year
Time Frame: pretreatment and 1 year
pretreatment and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NRZ Magdeburg Median Kliniken GmbH & Co

Investigators

  • Study Chair: Almut A Sickert, PhD, NRZ Median Klinik Magdeburg

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

August 1, 2004

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimate)

June 21, 2012

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIC-2012

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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