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

This study has been completed.
Sponsor:
Collaborators:
James A. Haley Veterans Administration Hospital
Hunter Holmes Mcguire Veteran Affairs Medical Center
Minneapolis Veterans Affairs Medical Center
VA Palo Alto Health Care System
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00540020
First received: October 4, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Other: Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans: DVBIC Randomized Clinical Trial of Two Rehabilitation Approaches

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • (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 Outcome Measures:
  • 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 ]

Enrollment: 360
Study Start Date: July 1996
Study Completion Date: May 2003
Arms Assigned Interventions
Experimental: Cognitive-Didactic
Developed 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).
Other: Rehabilitation
Experimental: Functional-Experiential
The 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.).
Other: Rehabilitation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540020

Sponsors and Collaborators
The Defense and Veterans Brain Injury Center
James A. Haley Veterans Administration Hospital
Hunter Holmes Mcguire Veteran Affairs Medical Center
Minneapolis Veterans Affairs Medical Center
VA Palo Alto Health Care System
Investigators
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
  More Information

No publications provided by Walter Reed Army Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00540020     History of Changes
Other Study ID Numbers: F292BL-C9, F292BL-C8, F292BL-C7, F292BL-C6
Study First Received: October 4, 2007
Last Updated: October 4, 2007
Health Authority: United States: Uniformed Services University of the Health Sciences
United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Brain Injuries
Cognition
Randomized Trials
Rehabilitation
Treatment Outcome

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 20, 2014