NCT02804412

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

7.8 years

First QC Date

June 9, 2016

Last Update Submit

June 14, 2016

Conditions

Keywords

communication disorderslanguage and speech disorder rehabilitationstroke

Outcome Measures

Primary Outcomes (1)

  • Change of aphasia by Aachener Aphasia Test (AAT)

    pretreatment and within 24 h post intervention

Secondary Outcomes (1)

  • Change of Communication Activity Log (CAL)

    pretreatment and within 24 h post intervention

Study Arms (3)

Control group

ACTIVE COMPARATOR

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

Other: Control group

CIAT-group

EXPERIMENTAL

Patients received constraint-induced aphasia therapy.

Other: CIAT-group

communication treatment group (CTG)

ACTIVE COMPARATOR

Patients received aphasia group therapy without constraints

Other: communication treatment group (CTG)

Interventions

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

Control group

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

CIAT-group

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

communication treatment group (CTG)

Eligibility Criteria

Age39 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first ever stroke
  • suffering from aphasia

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

AphasiaCommunication DisordersLanguageStroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersCommunicationBehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Hartwig Woldag, PhD

    NRZ Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of departement NRZ Leipzig

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 17, 2016

Study Start

March 1, 2005

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

June 17, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share