NCT01540383

Brief Summary

The purpose of this study is to examine whether 3 weeks of intensive language therapy provided in clinical in- and outpatient settings is effective in improving everyday communication in postacute/chronic post-stroke aphasia, as measured by performance on the Amsterdam Nijmegen Everyday Language Test (ANELT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 6, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

February 6, 2012

Last Update Submit

April 24, 2026

Conditions

AphasiaStroke

Keywords

CommunicationLanguageTreatmentInterventionTherapyEfficacyMaintenanceRecoveryOutcomeRehabilitationTreatment IntensityLanguage ImpairmentIntensive Language TherapyFunctional CommunicationFunctional ImprovementEvidence-Based InterventionHigh-Frequency

Outcome Measures

Primary Outcomes (1)

  • Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT) - A-scale

    Mean gain in ANELT understandability scores (ANELT A-scale; using the parallel versions ANELT-I and ANELT-II)

    Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)

Secondary Outcomes (10)

  • morbidity measure: changes in language-systematic aphasia screening (SAPS)

    Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)

  • morbidity measure: changes in communicative-pragmatic screening (KOPS)

    Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)

  • morbidity measure: changes in Modified Rankin Scale

    Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)

  • quality of life measure: changes in German version of the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)

    Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)

  • quality of life measure: changes in Communicative Effectiveness Index (CETI) and the ANELT partner communication questionnaire

    Baseline is compared to performance 6 months post 3 weeks of intensive language therapy.

  • +5 more secondary outcomes

Study Arms (2)

Intensive aphasia therapy group

EXPERIMENTAL

Group starts intensive integrative aphasia therapy within 3 workdays (or as soon as possible) after baseline exam

Behavioral: Intensive integrative aphasia therapy

Waiting list control group

OTHER

Group starts intensive integrative aphasia therapy after a waiting period of at least three weeks

Behavioral: Waiting list control group

Interventions

Intensive integrative aphasia therapyBEHAVIORAL

Intensive language therapy (3 weeks, 5 days/week, \>=2 hours/day) provided in regular clinical setting and consisting of a combination of language systematic and communicative-pragmatic treatment

Intensive aphasia therapy group
Waiting list control groupBEHAVIORAL

Control group starts intensive language therapy after a 3-week waiting period.

Waiting list control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of aphasia for at least 6 months after non-hemorrhagic or hemorrhagic cortical or subcortical-cortical stroke
  • native language German
  • participant's comprehension ability needs to be sufficiently high to give informed consent
  • participant's language abilities have to allow the administration of the Aachen Aphasia Test (AAT)

You may not qualify if:

  • aphasia due to non-vascular etiology
  • no evidence for aphasia (based on AAT subtests 'Token Test' and 'Written Language'
  • severe untreated medical conditions which prohibit participation in intensive language therapy
  • severe vision or hearing problems (uncorrected)
  • participation in another interventional or language therapy study within four weeks before potential enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Muenster

Münster, North Rhine-Westfalia, 48149, Germany

Location

Related Publications (2)

  • Breitenstein C, Grewe T, Floel A, Ziegler W, Springer L, Martus P, Huber W, Willmes K, Ringelstein EB, Haeusler KG, Abel S, Glindemann R, Domahs F, Regenbrecht F, Schlenck KJ, Thomas M, Obrig H, de Langen E, Rocker R, Wigbers F, Ruhmkorf C, Hempen I, List J, Baumgaertner A; FCET2EC study group. Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open-label, blinded-endpoint, controlled trial in a health-care setting. Lancet. 2017 Apr 15;389(10078):1528-1538. doi: 10.1016/S0140-6736(17)30067-3. Epub 2017 Mar 1.

    PMID: 28256356DERIVED

  • Baumgaertner A, Grewe T, Ziegler W, Floel A, Springer L, Martus P, Breitenstein C. FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial. Trials. 2013 Sep 23;14:308. doi: 10.1186/1745-6215-14-308.

    PMID: 24059983DERIVED

MeSH Terms

Conditions

AphasiaStrokeCommunicationLanguageLanguage Disorders

Condition Hierarchy (Ancestors)

Speech DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Annette Baumgaertner, PhD

    Hochschule Fresenius University of Applied Science

    PRINCIPAL INVESTIGATOR

  • Caterina Breitenstein, PhD

    Neurology, University of Muenster

    PRINCIPAL INVESTIGATOR

  • Agnes Floel, MD

    Neurology, Universitätsmedizin Charite, CCM, Berlin

    STUDY DIRECTOR

  • Wolfram Ziegler, PhD

    Clinical Neuropsychology Research Group (EKN), Klinikum Bogenhausen, München

    PRINCIPAL INVESTIGATOR

  • Tanja Grewe, PhD

    Hochschule Fresenius University of Applied Sciences

    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
SPONSOR

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 28, 2012

Study Start

April 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

DE(1)