NCT Number: NCT00540020
Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
A randomly assigned, intent-to-treat model of two different comprehensive treatment programs conducted between July 19 1996 and May 16, 2003 in 360 adult participants with moderate to severe TBI treated in four participating Veterans Administration TBI rehabilitation centers.
All patients admitted to the Commission for Accreditation of Rehabilitation Facilities (CARF) accredited acute inpatient rehabilitation brain injury programs at 4 participating Veterans Administration Medical Centers (VAMCs) (Minneapolis, Palo Alto, Richmond, and Tampa) during the study enrollment period were screened for eligibility.
The design was a randomized-controlled trial with two treatment arms (cognitive-didactic and functional-experiential), both embedded within an interdisciplinary TBI rehabilitation program. All treatment was hospital based. The interactive nature of the experimental conditions precluded subject blinding. Since each participating site serves a wide geographic area, the protocol permitted post-hospital outcome assessments by structured telephonic interview, to minimize drop out.
Participants completed baseline assessment then received by random assignment one of the two standardized protocol rehabilitation programs (summarized below and described in detail elsewhere). Participants received 1.5 to 2.5 hours daily of protocol-specific therapy plus another 2 to 2.5 hours daily of occupational and physical therapy. Independent teams of therapists functioned at each site to deliver the separate treatments and by necessity were not blinded to treatment. Protocol monitoring site visits, biweekly conference calls, and biannual investigator meetings were conducted to ensure uniformity of protocol treatment over time.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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.
Treatment and study plan
Primary outcomes
-
(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)
Time frame: One-year Follow-up
Secondary outcomes
-
The Functional Independence Measures (FIM)33, 34 consisting of motor and cognitive scores and the Disability Rating Scale Score (DRS)35 were measured.
Time frame: Discharge from Protocol Treatment
-
Quality of life, psychosocial function, behavioral, and mood state measures
Time frame: One-year Follow-up
Sponsors and collaborators
Lead sponsor
The Defense and Veterans Brain Injury Center
Fed
Collaborators
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- James A. Haley Veterans Administration Hospital
- Minneapolis Veterans Affairs Medical Center
- US Department of Veterans Affairs
- VA Palo Alto Health Care System
Registry information
Official study title
Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans: DVBIC Randomized Clinical Trial of Two Rehabilitation Approaches
Important dates
- Study start
- 1996
- Study completion
- 2003
- First posted
- Oct 5, 2007
- Registry last updated
- Oct 5, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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