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

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
The Defense and Veterans Brain Injury Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Traumatic Brain Injury focused on measuring Brain Injuries, Cognition, Randomized Trials, Rehabilitation, Treatment Outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Cognitive-Didactic

    Functional-Experiential

    Arm Description

    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).

    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.).

    Outcomes

    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)

    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.
    Quality of life, psychosocial function, behavioral, and mood state measures

    Full Information

    First Posted
    October 4, 2007
    Last Updated
    October 4, 2007
    Sponsor
    The Defense and Veterans Brain Injury Center
    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, US Department of Veterans Affairs
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00540020
    Brief Title
    Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans
    Official Title
    Rehabilitation of Traumatic Brain Injury in Active Duty Military Personnel and Veterans: DVBIC Randomized Clinical Trial of Two Rehabilitation Approaches
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    The Defense and Veterans Brain Injury Center
    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, US Department of Veterans Affairs

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury
    Keywords
    Brain Injuries, Cognition, Randomized Trials, Rehabilitation, Treatment Outcome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    360 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive-Didactic
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Functional-Experiential
    Arm Type
    Experimental
    Arm Description
    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.).
    Intervention Type
    Other
    Intervention Name(s)
    Rehabilitation
    Primary Outcome Measure Information:
    Title
    (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 Measure Information:
    Title
    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
    Title
    Quality of life, psychosocial function, behavioral, and mood state measures
    Time Frame
    One-year Follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deborah L. Warden, M.D.
    Organizational Affiliation
    The Defense and Veterans Brain Injury Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Elaine Date, M.D.
    Organizational Affiliation
    VA Palo Alto Health Care System
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Steven Scott, D.O.
    Organizational Affiliation
    James A. Haley VA
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Barbara Sigford, M.D., Ph.D.
    Organizational Affiliation
    Minneapolis VA
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    William Walker, M.D.
    Organizational Affiliation
    Hunter H. McGuire VAMC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19061734
    Citation
    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.
    Results Reference
    derived

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

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