NCT02153710

Brief Summary

This is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. The name of this disorder is called "aphasia." Individuals in this study will receive one of two treatments. The first is a phonological (sound level) treatment and the second is a semantic (word level) treatment. Individuals in both groups will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable stroke

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

March 11, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

July 1, 2019

Enrollment Period

3.4 years

First QC Date

March 20, 2014

Results QC Date

June 18, 2018

Last Update Submit

July 26, 2019

Conditions

Keywords

AphasiaAnomia

Outcome Measures

Primary Outcomes (1)

  • Spoken Word Production (Confrontation Naming)

    Reporting a change in percent correct scores pre-treatment versus 3-months post treatment. (0-100% scale)

    Pretreatment to 3 months following treatment termination change

Secondary Outcomes (2)

  • Response Latency

    Pretreatment to 3 months following treatment termination change

  • Verbs Correctly Named

    Pretreatment to 3 months following treatment termination change

Study Arms (2)

Phonomotor therapy

EXPERIMENTAL

Experimental group

Behavioral: Phonomotor Therapy

Semantic Feature Analysis therapy

ACTIVE COMPARATOR

Current standard of care therapy

Behavioral: Semantic Feature Analysis therapy

Interventions

Control therapy; current standard of care therapy

Semantic Feature Analysis therapy

Experimental therapy.

Phonomotor therapy

Eligibility Criteria

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

You may qualify if:

  • Single, left-hemisphere stroke
  • English as primary language prior to stroke

You may not qualify if:

  • Other neurological disorders
  • Untreated depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

StrokeAphasiaAnomia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Diane Kendall
Organization
University of Washington

Study Officials

  • Diane L. Kendall, PhD

    VA Puget Sound Health Care System Seattle Division, Seattle, WA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2014

First Posted

June 3, 2014

Study Start

March 11, 2014

Primary Completion

August 21, 2017

Study Completion

September 29, 2017

Last Updated

September 6, 2019

Results First Posted

September 6, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations