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

Aphasia Clinical Trial

— MCIAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625676
• Other study ID #: SIC-2012
• Status: Completed
• Phase: N/A
• First received: June 15, 2012
• Last updated: June 19, 2012
• Start date: August 2004
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: NRZ Magdeburg Median Kliniken GmbH & Co
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 34 Years to 84 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia

Intervention

Other:
• Investigate efficacy of modified ciat schedule
2 hours of training over 15 days
• examine the efficacy of standard treatment versus modified ciat schedule
2 hours of training over 15 days

Locations

Country	Name	City	State
Germany	NRZ Median Klinik	Magdeburg

Sponsors (1)

Lead Sponsor	Collaborator
NRZ Magdeburg Median Kliniken GmbH & Co

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT)		pretreatment and 4 weeks	Yes
Primary	change from pretreatment in Aachen Aphasia Test at 8 weeks		pretreatment and 8 weeks	Yes
Primary	change from pretreatment in Aachen Aphasia Test at 1 year		pretreatment and 1 year	Yes
Secondary	Change of Communicative Activity (CAL)		pretreatment and 4 weeks	Yes
Secondary	change from pretreatment in communication activity (CAL)at 8 weeks		pretreatment and 8 weeks	Yes
Secondary	Change from pretreatment in communication activity (CAL)at 1 year		pretreatment and 1 year	Yes