Aphasia Therapy: Factors of Efficacy

NCT ID: NCT02804412

Last Updated: 2016-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aphasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Patients received a standard, house-typical aphasia therapy in single and group therapy sessions

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

This is the control group with 14 h treatment over 10 workdays.

CIAT-group

Patients received constraint-induced aphasia therapy.

Group Type EXPERIMENTAL

CIAT-group

Intervention Type OTHER

Examine the efficacy of CIAT (30 h over 10 workdays) versus Control-group and communication treatment group.

communication treatment group (CTG)

Patients received aphasia group therapy without constraints

Group Type ACTIVE_COMPARATOR

communication treatment group (CTG)

Intervention Type OTHER

Examine the efficacy of CTG (30h over 10 wokrdays) versus CIAT-group and control group

Interventions

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Control group

This is the control group with 14 h treatment over 10 workdays.

Intervention Type OTHER

CIAT-group

Examine the efficacy of CIAT (30 h over 10 workdays) versus Control-group and communication treatment group.

Intervention Type OTHER

communication treatment group (CTG)

Examine the efficacy of CTG (30h over 10 wokrdays) versus CIAT-group and control group

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

39 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Hartwig Woldag

Head of departement NRZ Leipzig

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hartwig Woldag, PhD

Role: PRINCIPAL_INVESTIGATOR

NRZ Leipzig

References

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Woldag H, Voigt N, Bley M, Hummelsheim H. Constraint-Induced Aphasia Therapy in the Acute Stage: What Is the Key Factor for Efficacy? A Randomized Controlled Study. Neurorehabil Neural Repair. 2017 Jan;31(1):72-80. doi: 10.1177/1545968316662707. Epub 2016 Aug 9.

Reference Type DERIVED
PMID: 27506677 (View on PubMed)

Other Identifiers

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NRZ-CIAT

Identifier Type: -

Identifier Source: org_study_id

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