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CompletedNCT01625676MCIATUpdated Jun 21, 2012

Study of Modified Constraint-Induced Aphasia Therapy Schedule to Treat Patients Following Sub-acute Stroke

An interventional study of Investigate efficacy of modified ciat schedule and examine the efficacy of standard treatment versus modified ciat schedule in Aphasia, sponsored by NRZ Magdeburg Median Kliniken GmbH & Co. Completed at 1 site in Germany. Open to participants aged 34 Years to 84 Years. Per ClinicalTrials.gov, last updated 2012-06-21.

Sponsored by NRZ Magdeburg Median Kliniken GmbH & Co · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
34 Years to 84 Years
Sex
All
01

Study summary

The purpose of this study is to assess the feasibility of modified Constraint-Induced Aphasia Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified CIAT versus standard treatment with the same intensity of intervention.

02

Conditions studied

  • Aphasia

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Keywords

  • Aphasia
  • Rehabilitation of Speech and Language Disorders
03

In context

Aphasia

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

This study's enrollment of 100 is above the median of 30 across 316 interventional studies indexed under Aphasia.

Browse Aphasia studies →

Lead sponsor

This is the only study on the registry with NRZ Magdeburg Median Kliniken GmbH & Co as lead sponsor.

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

04

Who can participate

Ages eligible
34 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • clinical diagnosis of first-ever stroke
  • aphasia in sub-acute stage
  • german speakers

Exclusion criteria

Exclusion Criteria:

  • presence of residual aphasia
  • dysarthria and apraxia of speech
05

Study design

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

Study arms

  • Experimental
    CIAT-Group

    Patients received a modified constraint-induced therapy schedule

    Other: Investigate efficacy of modified ciat schedule

  • Active comparator
    standard treatment group

    patients received a standard aphasia therapy

    Other: examine the efficacy of standard treatment versus modified ciat schedule

Interventions

  • OtherInvestigate efficacy of modified ciat schedule

    2 hours of training over 15 days

  • Otherexamine the efficacy of standard treatment versus modified ciat schedule

    2 hours of training over 15 days

06

What researchers measure

Primary outcomes

  1. Change of aphasia and aphasic syndromes by Aachen Aphasia Test (AAT)

    Time frame: pretreatment and 4 weeks

  2. change from pretreatment in Aachen Aphasia Test at 8 weeks

    Time frame: pretreatment and 8 weeks

  3. change from pretreatment in Aachen Aphasia Test at 1 year

    Time frame: pretreatment and 1 year

Secondary outcomes

  1. Change of Communicative Activity (CAL)

    Time frame: pretreatment and 4 weeks

  2. change from pretreatment in communication activity (CAL)at 8 weeks

    Time frame: pretreatment and 8 weeks

  3. Change from pretreatment in communication activity (CAL)at 1 year

    Time frame: pretreatment and 1 year

07

Study locations

1 site
  • NRZ Median Klinik
    Magdeburg, 39120, Germany
08

References and documents

Publications

  • Sickert A, Anders LC, Munte TF, Sailer M. Constraint-induced aphasia therapy following sub-acute stroke: a single-blind, randomised clinical trial of a modified therapy schedule. J Neurol Neurosurg Psychiatry. 2014 Jan;85(1):51-5. doi: 10.1136/jnnp-2012-304297. Epub 2013 Jul 4. PubMed 23828834 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01625676
Lead sponsor
NRZ Magdeburg Median Kliniken GmbH & Co
Responsible party
Sponsor
First posted
Jun 21, 2012
Start date
Aug 2004
Primary completion
Oct 2010
Completion
Dec 2011
Last update
Jun 21, 2012

Study contacts

Almut A Sickert, PhD
study chair · NRZ Median Klinik Magdeburg

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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