NCT00827268

Brief Summary

This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have poor reading skills following a stroke. Specifically, this study is designed to improve skill in sounding out words for reading and spelling. The overall time commitment for participation in this study is approximately 11-30 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

2.5 years

First QC Date

January 20, 2009

Last Update Submit

November 28, 2017

Conditions

Keywords

DyslexiaReadingAphasiaStroke

Outcome Measures

Primary Outcomes (1)

  • Change in Real World Reading Skills

    Real World Reading Skills was tested using the Woodcock Reading Mastery Test-Revised

    Language testing are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment.

Study Arms (1)

Arm 1

OTHER

Repeated probes every 8 hours of treatment (1/week)

Behavioral: One-on-one treatment of reading difficulties

Interventions

Multimodal behavioral treatment focused on retraining sound to letter associations and skills in sounding out words when reading. Treatment has been pilot-tested in published papers since 1998.

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Adults with post-stroke reading difficulties (phonological alexia)
  • \>3 months post-stroke
  • native English speaker
  • can go in MRI scanner (3 to 6 scans),
  • participate in 90 to 120 free treatment sessions
  • return for 3-month post-treatment follow-up assessment \& MRI.

You may not qualify if:

  • mental illness
  • degenerative disease, visual or auditory acuity impairment
  • drug abuse
  • English is not first language
  • claustrophobia
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Related Links

MeSH Terms

Conditions

AphasiaStrokeDyslexia, AcquiredDyslexia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesSpecific Learning DisorderLearning DisabilitiesNeurocognitive DisordersMental DisordersNeurodevelopmental Disorders

Study Officials

  • Timothy W. Conway, PhD

    North Florida/South Georgia Veterans Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a repeated probe design study.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2011

Study Completion

July 1, 2012

Last Updated

November 30, 2017

Record last verified: 2017-11

Locations