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Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans

Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans: DVBIC Randomized Clinical Trial of Two Rehabilitation Approaches

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00540020
Enrollment
360
Registered
2007-10-05
Start date
1996-07-31
Completion date
2003-05-31
Last updated
2007-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Brain Injuries, Cognition, Randomized Trials, Rehabilitation, Treatment Outcome

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.

Detailed description

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.

Interventions

OTHERRehabilitation

Sponsors

James A. Haley Veterans Administration Hospital
CollaboratorFED
Hunter Holmes Mcguire Veteran Affairs Medical Center
CollaboratorFED
Minneapolis Veterans Affairs Medical Center
CollaboratorFED
VA Palo Alto Health Care System
CollaboratorFED
US Department of Veterans Affairs
CollaboratorFED
The Defense and Veterans Brain Injury Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
(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

MeasureTime frame
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 measuresOne-year Follow-up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026