Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223847
Status:
COMPLETED
Last Update Posted:
2009-01-01
First Post:
2005-09-14
Brief Title:
An Investigation of Constraint Induced Language Therapy for Aphasia
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
An Investigation of Constraint Induced Language Therapy for Aphasia
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the effects of intensive constraint induced language therapy CILT for individuals with chronic aphasia compared with traditional aphasia therapy The specific objectives of the proposed research are to determine the effects of therapy type CILT vs traditional and dose density intensive or distributed on speech therapy outcome In addition we will investigate the functional and qualitative impact of these interventions on functional communication
Detailed Description:
Objectives Aphasia is an acquired language disorder that is a common sequelae of stroke and poses tremendous levels of handicap for the victim as well as burden for caregivers While the efficacy of aphasia rehabilitation has been found to be statistically significant in its effect Wertz et al 1986 Robey 1994 its clinical significance has been often disappointing Siegel 1987 A promising avenue for rehabilitation of chronic aphasia based on the approach and principles of Constraint Induced Movement Therapy CIMT has recently been described Pulvermuller et al 2001 These investigators reported that individuals with chronic stable aphasia benefited statistically as well as clinically from language therapy designed to include attributes of CIMT forced-use delivered in high doses over a relatively short period of time In a limitation of the study the conditions of constraint-induced language treatment CILT and traditional treatment were confounded by differences in treatment intensity A pilot study funded by the VA Rehabilitation Research Development RRD to begin to control for confounding variables and treatment intensity is currently underway in a collaboration between the Houston VAMC Center of Excellence in Healthy Aging with Disabilities and the Brain Rehabilitation Research Center of Excellence in Gainesville FL While data collection is ongoing preliminary results suggest that individuals with chronic aphasia made substantial measurable change on a language battery following intensive CILT
The purpose of this study is to expand on the pilot work we have done and to identify the functional and qualitative impact of these interventions on communication in naturalistic settings and on caregivers Specifically we will compare the relative impact of therapy type constrained forced speech TX vs multi-modal PACE TX and dose intensity massed practice or distributed on rehabilitation of chronic aphasia
Research Plan Using between group comparisons and multiple-baseline single subject comparisons we will examine the impact of CILT in a larger group of individuals with aphasia controlling for the confounding variables of massed practice forced use and relevant context In addition we will investigate the functional and qualitative impact of these interventions on communication in naturalistic settings
Methods A total of 48 subjects collected at three sites Houston Gainesville and Tampa VAMCs will be randomly assigned across four experimental conditions 1 intensive CILT 2 intensive PACE therapy 3 distributed CILT and 4 distributed PACE therapy Pre and post treatment language assessments discourse samples daily probe measures and qualitative interviews will be used to measure TX effects In addition these measures will be recollected one month following TX to assess the stability of the TX effects
The purpose of this study is to expand on the pilot work we have done and to identify the functional and qualitative impact of these interventions on communication in naturalistic settings and on caregivers Specifically we will compare the relative impact of therapy type constrained forced speech TX vs multi-modal PACE TX and dose intensity massed practice or distributed on rehabilitation of chronic aphasia
Research Plan Using between group comparisons and multiple-baseline single subject comparisons we will examine the impact of CILT in a larger group of individuals with aphasia controlling for the confounding variables of massed practice forced use and relevant context In addition we will investigate the functional and qualitative impact of these interventions on communication in naturalistic settings
Methods A total of 48 subjects collected at three sites Houston Gainesville and Tampa VAMCs will be randomly assigned across four experimental conditions 1 intensive CILT 2 intensive PACE therapy 3 distributed CILT and 4 distributed PACE therapy Pre and post treatment language assessments discourse samples daily probe measures and qualitative interviews will be used to measure TX effects In addition these measures will be recollected one month following TX to assess the stability of the TX effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None