NCT01597037

Brief Summary

The purpose of this study is to evaluate how changing different conditions of the speech-language treatment (such as cues, feedback, complexity and practice schedule) affects the language outcome of study subjects with aphasia (i.e., difficulty with the comprehension and expression of spoken and written language) following a stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

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

June 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 30, 2018

Status Verified

November 1, 2018

Enrollment Period

6.3 years

First QC Date

May 9, 2012

Last Update Submit

November 28, 2018

Conditions

AphasiaStroke

Keywords

AphasiaSpeech Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Percent accurate script related words

    For trained script, untrained script, generalization script

    Change from baseline to post-treatment in three weeks

Secondary Outcomes (1)

  • Rate of script-related words

    Change from baseline to post-treatment in three weeks

Study Arms (4)

High complexity, high feedback

ACTIVE COMPARATOR

Scripts are one grade level higher than the typical script that would be provided for the severity of aphasia; there is an opportunity for the participant to listen to his/her production and assess performance.

Behavioral: Script training

High complexity, low feedback

ACTIVE COMPARATOR

Scripts are one grade level higher than the typical script that would be provided for the severity of aphasia; there is no opportunity for the participant to listen to his/her production and assess performance.

Behavioral: Script training

Low complexity, high feedback

ACTIVE COMPARATOR

Scripts are one grade level lower than the typical script that would be provided for the severity of aphasia; there is an opportunity for the participant to listen to his/her production and assess performance.

Behavioral: Script training

Low complexity, low feedback

ACTIVE COMPARATOR

Scripts are one grade level lower than the typical script that would be provided for the severity of aphasia; there is no opportunity for the participant to listen to his/her production and assess performance.

Behavioral: Script training

Interventions

Script trainingBEHAVIORAL

90 minutes/day, 6 days a week; includes 3 weeks of training

High complexity, high feedbackHigh complexity, low feedbackLow complexity, high feedbackLow complexity, low feedback

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A single unilateral left-hemisphere stroke
  • Aphasia Quotient between 40 and 80 on the Western Aphasia Battery
  • Age 21 or older
  • At least 6 months post-stroke
  • Able to comply with the study protocol
  • Premorbidly right-handed, as determined by the Edinburgh Handedness Inventory
  • Fluent in English premorbidly
  • Completed at least 8th grade education

You may not qualify if:

  • More than one stroke
  • Any other neurological condition that could potentially affect cognition, speech or language.
  • Global aphasia or inability to participate in routine speech therapy
  • Major active psychiatric illness that may interfere with required study procedures
  • Untreated or inadequately treated depression
  • Current abuse of alcohol or drugs
  • Unable to understand, cooperate or comply with study procedures
  • Significant visual or auditory impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Cherney LR, Van Vuuren S. Complexity and Feedback During Script Training in Aphasia: A Feasibility Study. Arch Phys Med Rehabil. 2022 Jul;103(7S):S205-S214. doi: 10.1016/j.apmr.2022.03.002. Epub 2022 Mar 15.

    PMID: 35304120DERIVED

MeSH Terms

Conditions

AphasiaStroke

Condition Hierarchy (Ancestors)

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

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
Senior Research Scientist

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 11, 2012

Study Start

June 1, 2011

Primary Completion

September 1, 2017

Study Completion

April 1, 2018

Last Updated

November 30, 2018

Record last verified: 2018-11

Locations

US(1)