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

October 4, 2007 updated by: The Defense and Veterans Brain Injury Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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)
Time Frame: One-year Follow-up
One-year Follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Discharge from Protocol Treatment
Quality of life, psychosocial function, behavioral, and mood state measures
Time Frame: One-year Follow-up
One-year Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Defense and Veterans Brain Injury Center

Collaborators

Minneapolis Veterans Affairs Medical Center
US Department of Veterans Affairs
VA Palo Alto Health Care System
James A. Haley Veterans Administration Hospital
Hunter Holmes Mcguire Veteran Affairs Medical Center

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1996

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

October 4, 2007

First Submitted That Met QC Criteria

October 4, 2007

First Posted (Estimate)

October 5, 2007

Study Record Updates

Last Update Posted (Estimate)

October 5, 2007

Last Update Submitted That Met QC Criteria

October 4, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F292BL-C9
  • F292BL-C8
  • F292BL-C7
  • F292BL-C6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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