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

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ClinicalTrials.gov Identifier: NCT01625676
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : June 21, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Aphasia Other: Investigate efficacy of modified ciat schedule Other: examine the efficacy of standard treatment versus modified ciat schedule

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Constraint-Induced Aphasia Therapy Following Sub-acute Stroke: A Modified Therapy Schedule
Study Start Date : August 2004
Primary Completion Date : October 2010
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT) [ Time Frame: pretreatment and 4 weeks ]
  2. change from pretreatment in Aachen Aphasia Test at 8 weeks [ Time Frame: pretreatment and 8 weeks ]
  3. change from pretreatment in Aachen Aphasia Test at 1 year [ Time Frame: pretreatment and 1 year ]

Secondary Outcome Measures :
  1. Change of Communicative Activity (CAL) [ Time Frame: pretreatment and 4 weeks ]
  2. change from pretreatment in communication activity (CAL)at 8 weeks [ Time Frame: pretreatment and 8 weeks ]
  3. Change from pretreatment in communication activity (CAL)at 1 year [ Time Frame: pretreatment and 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   34 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01625676


Locations
Germany
NRZ Median Klinik
Magdeburg, Germany, 39120
Sponsors and Collaborators
NRZ Magdeburg Median Kliniken GmbH & Co
Investigators
Study Chair: Almut A Sickert, PhD NRZ Median Klinik Magdeburg
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NRZ Magdeburg Median Kliniken GmbH & Co
ClinicalTrials.gov Identifier: NCT01625676     History of Changes
Other Study ID Numbers: SIC-2012
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by NRZ Magdeburg Median Kliniken GmbH & Co:
Aphasia
Rehabilitation of Speech and Language Disorders

Additional relevant MeSH terms:
Aphasia
Stroke
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases