NCT01625676

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2004

Longer than P75 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

Study Start

First participant enrolled

August 1, 2004

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

Enrollment Period

6.2 years

First QC Date

June 15, 2012

Last Update Submit

June 19, 2012

Conditions

Keywords

AphasiaRehabilitation of Speech and Language Disorders

Outcome Measures

Primary Outcomes (3)

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

    pretreatment and 4 weeks

  • change from pretreatment in Aachen Aphasia Test at 8 weeks

    pretreatment and 8 weeks

  • change from pretreatment in Aachen Aphasia Test at 1 year

    pretreatment and 1 year

Secondary Outcomes (3)

  • Change of Communicative Activity (CAL)

    pretreatment and 4 weeks

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

    pretreatment and 8 weeks

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

    pretreatment and 1 year

Study Arms (2)

CIAT-Group

EXPERIMENTAL

Patients received a modified constraint-induced therapy schedule

Other: Investigate efficacy of modified ciat schedule

standard treatment group

ACTIVE COMPARATOR

patients received a standard aphasia therapy

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

Interventions

2 hours of training over 15 days

CIAT-Group

2 hours of training over 15 days

standard treatment group

Eligibility Criteria

Age34 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • presence of residual aphasia
  • dysarthria and apraxia of speech

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NRZ Median Klinik

Magdeburg, Germany, 39120, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

AphasiaLanguage Disorders

Condition Hierarchy (Ancestors)

Speech DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Almut A Sickert, PhD

    NRZ Median Klinik Magdeburg

    STUDY CHAIR

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

June 15, 2012

First Posted

June 21, 2012

Study Start

August 1, 2004

Primary Completion

October 1, 2010

Study Completion

December 1, 2011

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations