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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NRZ Magdeburg Median Kliniken GmbH & Co
ClinicalTrials.gov Identifier:
NCT01625676
First received: June 15, 2012
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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 Intervention
Aphasia
Other: Investigate efficacy of modified ciat schedule
Other: examine the efficacy of standard treatment versus modified ciat schedule

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Constraint-Induced Aphasia Therapy Following Sub-acute Stroke: A Modified Therapy Schedule

Resource links provided by NLM:


Further study details as provided by NRZ Magdeburg Median Kliniken GmbH & Co:

Primary Outcome Measures:
  • Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT) [ Time Frame: pretreatment and 4 weeks ] [ Designated as safety issue: Yes ]
  • change from pretreatment in Aachen Aphasia Test at 8 weeks [ Time Frame: pretreatment and 8 weeks ] [ Designated as safety issue: Yes ]
  • change from pretreatment in Aachen Aphasia Test at 1 year [ Time Frame: pretreatment and 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change of Communicative Activity (CAL) [ Time Frame: pretreatment and 4 weeks ] [ Designated as safety issue: Yes ]
  • change from pretreatment in communication activity (CAL)at 8 weeks [ Time Frame: pretreatment and 8 weeks ] [ Designated as safety issue: Yes ]
  • Change from pretreatment in communication activity (CAL)at 1 year [ Time Frame: pretreatment and 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: August 2004
Study Completion Date: December 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   34 Years to 84 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by NRZ Magdeburg Median Kliniken GmbH & Co

Additional 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
Study First Received: June 15, 2012
Last Updated: June 19, 2012
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Language Disorders
Aphasia
Stroke
Speech 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

ClinicalTrials.gov processed this record on August 26, 2014