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

NCT ID: NCT00540020

Last Updated: 2007-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-07-31
• Study Completion Date: 2003-05-31

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.

Conditions

Traumatic Brain Injury

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: OTHER

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.).

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: OTHER

Interventions

Rehabilitation

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James A. Haley Veterans Administration Hospital

FED

Sponsor Role: collaborator

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED

Sponsor Role: collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

VA Palo Alto Health Care System

FED

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

The Defense and Veterans Brain Injury Center

FED

Sponsor Role: lead

Principal Investigators

Deborah L. Warden, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Defense and Veterans Brain Injury Center

Elaine Date, M.D.

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Steven Scott, D.O.

Role: PRINCIPAL_INVESTIGATOR

James A. Haley VA

Barbara Sigford, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA

William Walker, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hunter H. McGuire VAMC

References

Vanderploeg RD, Schwab K, Walker WC, Fraser JA, Sigford BJ, Date ES, Scott SG, Curtiss G, Salazar AM, Warden DL; Defense and Veterans Brain Injury Center Study Group. Rehabilitation of traumatic brain injury in active duty military personnel and veterans: Defense and Veterans Brain Injury Center randomized controlled trial of two rehabilitation approaches. Arch Phys Med Rehabil. 2008 Dec;89(12):2227-38. doi: 10.1016/j.apmr.2008.06.015.

Reference Type: DERIVED

PMID: 19061734 (View on PubMed)

Other Identifiers

F292BL-C8

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Identifier Source: secondary_id

F292BL-C7

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F292BL-C6

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F292BL-C9

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Identifier Source: org_study_id