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CompletedNCT02804412Updated Jun 17, 2016

Aphasia Therapy: Factors of Efficacy

An interventional study of Control group and CIAT-group in Aphasia, sponsored by University of Leipzig. Completed. Open to participants aged 39 Years to 89 Years. Per ClinicalTrials.gov, last updated 2016-06-17.

Sponsored by University of Leipzig · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
39 Years to 89 Years
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Aphasia

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Keywords

  • communication disorders
  • language and speech disorder rehabilitation
  • stroke
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In context

Aphasia

365 studies on the registry are indexed under Aphasia; 89 are open to participants now.

This study's enrollment of 60 is above the median of 30 across 316 interventional studies indexed under Aphasia.

Browse Aphasia studies →

Lead sponsor

University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
39 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • first ever stroke
  • suffering from aphasia

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Control group

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

    Other: Control group

  • Experimental
    CIAT-group

    Patients received constraint-induced aphasia therapy.

    Other: CIAT-group

  • Active comparator
    communication treatment group (CTG)

    Patients received aphasia group therapy without constraints

    Other: communication treatment group (CTG)

Interventions

  • OtherControl group

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

  • OtherCIAT-group

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

  • Othercommunication treatment group (CTG)

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

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What researchers measure

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)

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

    Time frame: pretreatment and within 24 h post intervention

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 27506677 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02804412
Lead sponsor
University of Leipzig
Responsible party
Hartwig Woldag (Head of departement NRZ Leipzig, University of Leipzig) — Principal investigator
First posted
Jun 17, 2016
Start date
Mar 2005
Primary completion
Jan 2013
Completion
Mar 2013
Last update
Jun 17, 2016

Study contacts

Hartwig Woldag, PhD
principal investigator · NRZ Leipzig

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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