Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01163461
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 49
• Patients Per Site Per Month: 0.6

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Aphasia	Behavioral: speech therapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Real Word Effects in Phonological Treatment for Word Retrieval
• Actual Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Jun 30, 2013
• Actual Study Completion Date: Sep 30, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate Treatment individuals will receive 60 hours of speech therapy	Behavioral: speech therapy; individuals will receive 60 hours of behavioral speech therapy
Experimental: Delayed Treatment individuals will receive 60 hours of speech therapy after 6 week delay period	Behavioral: speech therapy; individuals will receive 60 hours of behavioral speech therapy

Outcome Measures

Primary Outcome Measures

1. Speech Production [Baseline to one week post treatment termination and three months post treatment termination]

   percent change in the number of untrained words spoken correctly

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• left hemisphere stroke

• monolingual English speaking

• right handed

• presence of aphasia

Exclusion Criteria:

• preexisting neurological condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington	United States	98108

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Diane L. Kendall, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01163461
• Other Study ID Numbers: C6572-R
• First Posted: Jul 15, 2010
• Last Update Posted: Aug 31, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Aphasia

Study Results

Participant Flow

Arm/Group Title	Delayed Aphasia Therapy	Immediate Aphasia Therapy
Arm/Group Description	14 individuals were randomized to received aphasia therapy following a 6-week control delay phase. Upon completion of the 6-week control phase, they received 60 hours of behavioral therapy	14 individuals were randomized to received 60 hours of aphasia therapy immediately following testing. (no delay)
Period Title: Overall Study
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Behavioral Aphasia Therapy
Arm/Group Description	Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
Overall Participants	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56 (15)
Sex: Female, Male (Count of Participants)
Female	14 50%
Male	14 50%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Aphasia Therapy
Arm/Group Description	Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
Measure Participants	28
% change immediately post treatment	5.27 (8.09)
% change 3 months post treatment	5.28 (7.55)

Adverse Events

Arm/Group Title	Single Group Open Trial
Arm/Group Description	28 individuals were randomized to receive either immediate speech therapy, or delayed speech therapy (following a 6 week delay period to control for Hawthorne effects). All participants received 60 hours of speech therapy 2 hours/day, 5 days/week for 6 weeks. Language behaviors were testing before, after and 3 months later.
All Cause Mortality
	Single Group Open Trial
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single Group Open Trial
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Other (Not Including Serious) Adverse Events
	Single Group Open Trial
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Social circumstances
No adverse events	0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.