Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans
4 other identifiers
interventional
360
0 countries
N/A
Brief Summary
Context: Traumatic brain injury (TBI) is a common condition associated with significant long-term cognitive, behavioral, and functional morbidities. There are minimal controlled efficacy data of various acute rehabilitation intervention approaches. Objective: To determine the relative efficacy of two different acute TBI rehabilitation approaches - cognitive-didactic versus functional-experiential. Secondarily to determine relative efficacy for different patient subpopulations based on baseline cognitive functioning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 1996
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
July 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 4, 2007
CompletedFirst Posted
Study publicly available on registry
October 5, 2007
CompletedOctober 5, 2007
October 1, 2007
October 4, 2007
October 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
(1) Functional independence (i.e., ability to live independently with less than 3 hours of assistance per week) (2) Return to work/school (i.e., paid employment or school enrollment, either full or part time)
One-year Follow-up
Secondary Outcomes (2)
The Functional Independence Measures (FIM)33, 34 consisting of motor and cognitive scores and the Disability Rating Scale Score (DRS)35 were measured.
Discharge from Protocol Treatment
Quality of life, psychosocial function, behavioral, and mood state measures
One-year Follow-up
Study Arms (2)
Cognitive-Didactic
EXPERIMENTALDeveloped by Sohlberg \& Mateer to target four cognitive domains often impaired by TBI: attention, memory, executive functions, and pragmatic communication. Subjects practiced progressively more difficult paper-and-pencil or computerized cognitive tasks in 1:1 cognitive therapy sessions (1.5-2.5 hours daily).
Functional-Experiential
EXPERIMENTALThe works of Giles and Clark-Wilson and Hartley guided the basic concepts and treatment of the functional-experiential arm (Functional). The objective of the functional protocol was to use real life performance situations and common tasks to remediate or compensate for functional deficits after brain injury. Functional protocol treatment interventions (1.5-2.5 hours daily) typically occurred in group settings and natural environments (hospital recreation areas, group rooms, simulated home environments in the dining room, community outings, etc.).
Interventions
Eligibility Criteria
You may qualify if:
- moderate-to-severe closed head injury, manifested by a post-resuscitation Glasgow Coma Scale (GCS) score of 12 or less, or coma of 12 hours or more , or posttraumatic amnesia (PTA) of 24 hours or more, and/or focal cerebral contusion or hemorrhage on computed tomography (CT) or magnetic resonance imaging (MRI)
- documented traumatic brain injury within 6 months of randomization
- Rancho Los Amigos Scale (RLAS) cognitive level of 5-7 at time of randomization
- age 18 or older
- active duty military member or veteran
- anticipated length of needed acute interdisciplinary TBI rehabilitation of 30 days or more
You may not qualify if:
- history of prior moderate to severe traumatic brain injury or other pre-injury severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Defense and Veterans Brain Injury Centerlead
- James A. Haley Veterans Administration Hospitalcollaborator
- Hunter Holmes Mcguire Veteran Affairs Medical Centercollaborator
- Minneapolis Veterans Affairs Medical Centercollaborator
- VA Palo Alto Health Care Systemcollaborator
- US Department of Veterans Affairscollaborator
Related Publications (1)
Vanderploeg RD, Schwab K, Walker WC, Fraser JA, Sigford BJ, Date ES, Scott SG, Curtiss G, Salazar AM, Warden DL; Defense and Veterans Brain Injury Center Study Group. Rehabilitation of traumatic brain injury in active duty military personnel and veterans: Defense and Veterans Brain Injury Center randomized controlled trial of two rehabilitation approaches. Arch Phys Med Rehabil. 2008 Dec;89(12):2227-38. doi: 10.1016/j.apmr.2008.06.015.
PMID: 19061734DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah L. Warden, M.D.
The Defense and Veterans Brain Injury Center
- PRINCIPAL INVESTIGATOR
Elaine Date, M.D.
VA Palo Alto Health Care System
- PRINCIPAL INVESTIGATOR
Steven Scott, D.O.
James A. Haley VA
- PRINCIPAL INVESTIGATOR
Barbara Sigford, M.D., Ph.D.
Minneapolis VA
- PRINCIPAL INVESTIGATOR
William Walker, M.D.
Hunter H. McGuire VAMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
October 4, 2007
First Posted
October 5, 2007
Study Start
July 1, 1996
Study Completion
May 1, 2003
Last Updated
October 5, 2007
Record last verified: 2007-10