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Completed

NCT Number: NCT02804412

Aphasia Therapy: Factors of Efficacy

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.

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Key information

Conditions

Aphasia Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Communication Disorders Language Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

39 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Control Group

Other

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

CIAT-group

Other

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

communication treatment group (CTG)

Other

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

Primary outcomes

  1. Change of aphasia by Aachener Aphasia Test (AAT)

    Time frame: pretreatment and within 24 h post intervention

Secondary outcomes

  1. Change of Communication Activity Log (CAL)

    Time frame: pretreatment and within 24 h post intervention

    The CAL is a two-part questionnaire rating the amount and the quality of daily communication on a six-point scale

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

Constraint Induced Aphasia Therapy in Stroke Patients in Acute Stage.

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Jun 17, 2016
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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