Aphasia Therapy: Factors of Efficacy

Aphasia Clinical Trial

Official title:

Constraint Induced Aphasia Therapy in Stroke Patients in Acute Stage.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804412
• Other study ID #: NRZ-CIAT
• Status: Completed
• Phase: N/A
• First received: June 9, 2016
• Last updated: June 14, 2016
• Start date: March 2005
• Est. completion date: March 2013

Study information

• Verified date: June 2016
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Constraint-induced aphasia therapy (CIAT) has proven effective in stroke patients. It has remained unclear, however, whether intensity of therapy or constraint is the relevant factor. This study will give an answer to this question to improve speech and language therapy.

Description:

Although there is clear evidence that aphasia therapy is effective, questions remain as to the intensity of administered therapy, the preferred therapeutic approach and its initiation with regard to stroke onset. CIAT is a a high intense group therapy administered over 2 weeks. Additionally, patients have to communicate solely in spoken words or sentences (constraint). This study compares CIAT with an approach of the same intensity without constraints and a less intense house-typical therapeutic approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 39 Years to 89 Years

Eligibility

Inclusion Criteria:

• first ever stroke

• suffering from aphasia

Exclusion Criteria:

• severe cognitive or attentional impairments

• severe depression

• left-handedness

• severe dysarthria

• apraxia of speech

• severe deafness

• additional neurological diseases affecting speech (e.g. Parkinson's disease)

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:
• Control group
This is the control group with 14 h treatment over 10 workdays.
• CIAT-group
Examine the efficacy of CIAT (30 h over 10 workdays) versus Control-group and communication treatment group.
• communication treatment group (CTG)
Examine the efficacy of CTG (30h over 10 wokrdays) versus CIAT-group and control group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of aphasia by Aachener Aphasia Test (AAT)		pretreatment and within 24 h post intervention	No
Secondary	Change of Communication Activity Log (CAL)	The CAL is a two-part questionnaire rating the amount and the quality of daily communication on a six-point scale	pretreatment and within 24 h post intervention	No