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Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
speech therapy
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • left hemisphere stroke
  • monolingual English speaking
  • right handed
  • presence of aphasia

Exclusion Criteria:

  • preexisting neurological condition

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate Treatment

Delayed Treatment

Arm Description

individuals will receive 60 hours of speech therapy

individuals will receive 60 hours of speech therapy after 6 week delay period

Outcomes

Primary Outcome Measures

Speech Production
percent change in the number of untrained words spoken correctly

Secondary Outcome Measures

Full Information

First Posted
July 14, 2010
Last Updated
August 30, 2017
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01163461
Brief Title
Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia
Official Title
Real Word Effects in Phonological Treatment for Word Retrieval
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2010 (Actual)
Primary Completion Date
June 30, 2013 (Actual)
Study Completion Date
September 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 who participate in this study will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).
Detailed Description
The study design was a single group (n=26) with repeated testing (3 times) pre- and post-treatment. All participants received the same treatment protocol (described in detail in Appendix A and in Minkina et al. (under review)). In order to control for improvement in language function related to passage of time, and for the effect of repeated exposure to outcome measures, individuals were randomly assigned to one of two conditions: delayed treatment or immediate treatment (Figure 2). Participants who were randomized to the delayed group received repeated testing three times before and three times after a six-week delay. During the delay phase they were permitted to participate in usual speech-language care (e.g., conversation groups and individual therapy). Standardized assessments and outcome measures (described in detail below) were administered prior to the start of treatment (for both immediate and delayed groups), at the end of the delay phase (delayed group only), immediately after treatment termination, and at three months post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment
Arm Type
Experimental
Arm Description
individuals will receive 60 hours of speech therapy
Arm Title
Delayed Treatment
Arm Type
Experimental
Arm Description
individuals will receive 60 hours of speech therapy after 6 week delay period
Intervention Type
Behavioral
Intervention Name(s)
speech therapy
Intervention Description
individuals will receive 60 hours of behavioral speech therapy
Primary Outcome Measure Information:
Title
Speech Production
Description
percent change in the number of untrained words spoken correctly
Time Frame
Baseline to one week post treatment termination and three months post treatment termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: left hemisphere stroke monolingual English speaking right handed presence of aphasia Exclusion Criteria: preexisting neurological condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane L. Kendall, PhD
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23695900
Citation
Kendall DL, Hunting Pompon R, Brookshire CE, Minkina I, Bislick L. An analysis of aphasic naming errors as an indicator of improved linguistic processing following phonomotor treatment. Am J Speech Lang Pathol. 2013 May;22(2):S240-9. doi: 10.1044/1058-0360(2012/12-0078).
Results Reference
result

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Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia

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