NCT01163461

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

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

First Submitted

Initial submission to the registry

July 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 16, 2015

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

July 14, 2010

Results QC Date

September 29, 2014

Last Update Submit

August 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Speech Production

    percent change in the number of untrained words spoken correctly

    Baseline to one week post treatment termination and three months post treatment termination

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

individuals will receive 60 hours of speech therapy

Behavioral: speech therapy

Delayed Treatment

EXPERIMENTAL

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

Behavioral: speech therapy

Interventions

speech therapyBEHAVIORAL

individuals will receive 60 hours of behavioral speech therapy

Delayed TreatmentImmediate Treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • preexisting neurological condition

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

Related Publications (1)

  • 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).

MeSH Terms

Conditions

Aphasia

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Results Point of Contact

Title
Dr. Diane Kendall (PI)
Organization
VAMC Puget Sound

Study Officials

  • Diane L. Kendall, PhD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 15, 2010

Study Start

September 1, 2010

Primary Completion

June 30, 2013

Study Completion

September 30, 2014

Last Updated

August 31, 2017

Results First Posted

July 16, 2015

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations