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

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Investigate efficacy of modified ciat schedule
examine the efficacy of standard treatment versus modified ciat schedule
Sponsored by
NRZ Magdeburg Median Kliniken GmbH & Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Rehabilitation of Speech and Language Disorders

Eligibility Criteria

34 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NRZ Median Klinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CIAT-Group

standard treatment group

Arm Description

Patients received a modified constraint-induced therapy schedule

patients received a standard aphasia therapy

Outcomes

Primary Outcome Measures

Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT)
change from pretreatment in Aachen Aphasia Test at 8 weeks
change from pretreatment in Aachen Aphasia Test at 1 year

Secondary Outcome Measures

Change of Communicative Activity (CAL)
change from pretreatment in communication activity (CAL)at 8 weeks
Change from pretreatment in communication activity (CAL)at 1 year

Full Information

First Posted
June 15, 2012
Last Updated
June 19, 2012
Sponsor
NRZ Magdeburg Median Kliniken GmbH & Co
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1. Study Identification

Unique Protocol Identification Number
NCT01625676
Brief Title
Study of Modified Constraint-Induced Aphasia Therapy Schedule to Treat Patients Following Sub-acute Stroke
Acronym
MCIAT
Official Title
Constraint-Induced Aphasia Therapy Following Sub-acute Stroke: A Modified Therapy Schedule
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NRZ Magdeburg Median Kliniken GmbH & Co

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Aphasia, Rehabilitation of Speech and Language Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CIAT-Group
Arm Type
Experimental
Arm Description
Patients received a modified constraint-induced therapy schedule
Arm Title
standard treatment group
Arm Type
Active Comparator
Arm Description
patients received a standard aphasia therapy
Intervention Type
Other
Intervention Name(s)
Investigate efficacy of modified ciat schedule
Intervention Description
2 hours of training over 15 days
Intervention Type
Other
Intervention Name(s)
examine the efficacy of standard treatment versus modified ciat schedule
Intervention Description
2 hours of training over 15 days
Primary Outcome Measure Information:
Title
Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT)
Time Frame
pretreatment and 4 weeks
Title
change from pretreatment in Aachen Aphasia Test at 8 weeks
Time Frame
pretreatment and 8 weeks
Title
change from pretreatment in Aachen Aphasia Test at 1 year
Time Frame
pretreatment and 1 year
Secondary Outcome Measure Information:
Title
Change of Communicative Activity (CAL)
Time Frame
pretreatment and 4 weeks
Title
change from pretreatment in communication activity (CAL)at 8 weeks
Time Frame
pretreatment and 8 weeks
Title
Change from pretreatment in communication activity (CAL)at 1 year
Time Frame
pretreatment and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Almut A Sickert, PhD
Organizational Affiliation
NRZ Median Klinik Magdeburg
Official's Role
Study Chair
Facility Information:
Facility Name
NRZ Median Klinik
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23828834
Citation
Sickert A, Anders LC, Munte TF, Sailer M. Constraint-induced aphasia therapy following sub-acute stroke: a single-blind, randomised clinical trial of a modified therapy schedule. J Neurol Neurosurg Psychiatry. 2014 Jan;85(1):51-5. doi: 10.1136/jnnp-2012-304297. Epub 2013 Jul 4.
Results Reference
derived

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

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