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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540020
• Other study ID #: F292BL-C9
• Secondary ID: F292BL-C8F292BL-
• Status: Completed
• Phase: N/A
• First received: October 4, 2007
• Last updated: October 4, 2007
• Start date: July 1996
• Est. completion date: May 2003

Study information

• Verified date: October 2007
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Uniformed Services University of the Health SciencesUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Other:
• Rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
The Defense and Veterans Brain Injury Center	Hunter Holmes Mcguire Veteran Affairs Medical Center, James A. Haley Veterans Administration Hospital, Minneapolis Veterans Affairs Medical Center, VA Office of Research and Development, VA Palo Alto Health Care System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(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	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
Secondary	Quality of life, psychosocial function, behavioral, and mood state measures		One-year Follow-up