Original article
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

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Abstract

Vanderploeg RD, Schwab K, Walker WC, Fraser JA, Sigford BJ, Date ES, Scott SG, Curtiss G, Salazar AM, Warden DL, for the 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.

Objectives

To determine the relative efficacy of 2 different acute traumatic brain injury (TBI) rehabilitation approaches: cognitive didactic versus functional-experiential, and secondarily to determine relative efficacy for different patient subpopulations.

Design

Randomized, controlled, intent-to-treat trial comparing 2 alternative TBI treatment approaches.

Setting

Four Veterans Administration acute inpatient TBI rehabilitation programs.

Participants

Adult veterans or active duty military service members (N=360) with moderate to severe TBI.

Interventions

One and a half to 2.5 hours of protocol-specific cognitive-didactic versus functional-experiential rehabilitation therapy integrated into interdisciplinary acute Commission for Accreditation of Rehabilitation Facilities–accredited inpatient TBI rehabilitation programs with another 2 to 2.5 hours daily of occupational and physical therapy. Duration of protocol treatment varied from 20 to 60 days depending on the clinical needs and progress of each participant.

Main Outcome Measures

The 2 primary outcome measures were functional independence in living and return to work and/or school assessed by independent evaluators at 1-year follow-up. Secondary outcome measures consisted of the FIM, Disability Rating Scale score, and items from the Present State Exam, Apathy Evaluation Scale, and Neurobehavioral Rating Scale.

Results

The cognitive-didactic and functional-experiential treatments did not result in overall group differences in the broad 1-year primary outcomes. However, analysis of secondary outcomes found differentially better immediate posttreatment cognitive function (mean ± SD cognitive FIM) in participants randomized to cognitive-didactic treatment (27.3±6.2) than to functional treatment (25.6±6.0, t332=2.56, P=.01). Exploratory subgroup analyses found that younger participants in the cognitive arm had a higher rate of returning to work or school than younger patients in the functional arm, whereas participants older than 30 years and those with more years of education in the functional arm had higher rates of independent living status at 1 year posttreatment than similar patients in the cognitive arm.

Conclusions

Results from this large multicenter randomized controlled trial comparing cognitive-didactic and functional-experiential approaches to brain injury rehabilitation indicated improved but similar long-term global functional outcome. Participants in the cognitive treatment arm achieved better short-term functional cognitive performance than patients in the functional treatment arm. The current increase in war-related brain injuries provides added urgency for rigorous study of rehabilitation treatments. (http://ClinicalTrials.gov ID# NCT00540020.)

Section snippets

Participants

All patients admitted to the CARF-accredited acute inpatient rehabilitation brain injury programs at 4 participating VAMCs (Minneapolis, Palo Alto, Richmond, and Tampa) during the study enrollment period were screened for eligibility. Inclusion criteria were (1) moderate-to-severe nonpenetrating TBI within the preceding 6 months, manifested by a postresuscitation Glasgow Coma Scale score of 12 or less, or coma of 12 hours or more, or PTA of 24 hours or more, and/or focal cerebral contusion or

Recruitment

During enrollment (July 19, 1996–May 16, 2003), 476 patients out of the 897 total rehabilitation admissions fit eligibility criteria and were invited to participate. Of these, 366 subjects consented and were randomized (fig 1). Five subjects rescinded consent before study procedures began, and 1 withdrew consent later, leaving 360 subjects, 180 in each treatment arm, for the intent-to-treat sample. These were distributed among the 4 study sites as follows: Minneapolis (n=65), Palo Alto (n=91),

Discussion

This study is the first randomized clinical head-to-head comparison of 2 acute inpatient interdisciplinary rehabilitation approaches to treating moderate to severe TBI. The competing treatment approaches, cognitive versus functional, were concurrently implemented in a large military and veteran sample using independent teams to maintain treatment purity. The primary outcomes were 1-year global functional measures rather than short-term impairment-based measures and did not differ between

Conclusions

The results from this trial, with the largest sample ever treated in a randomized controlled rehabilitation trial of TBI, indicated no difference between cognitive-didactic and functional-experiential approaches to brain injury rehabilitation on the primary 1-year global outcome measures of the study. However, patients in the cognitive treatment arm had better posttreatment cognitive performance than patients in the functional treatment arm. In addition, subgroup analyses found that younger

Acknowledgments

We thank the Defense and Veterans Brain Injury Center Study Group. Minneapolis VAMC: Barbara Sigford, MD, PhD, Rose Collins, PhD, Richard A. Lanham Jr, PhD, Jeanne Lojovich, PT, NCS, Donald MacLennan, MA, CCC/SLP, Michelle Peterson, DPT, NCS, Deborah Voydetich, OTR. Palo Alto VAMC: Elaine S. Date, MD, Rex A. Bierley, PhD, John H. Poole, PhD, Jill Storms, OTR/L, Sarah Eggen Thornhill, OTR/L, Rose Marie Salerno, RN. Richmond VAMC: William Walker, MD, Tripti Jena, MD, Micaela Cornis-Pop, PhD,

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  • Cited by (0)

    Supported by the Defense and Veterans Brain Injury Center, Uniformed Services University of the Health Sciences, Bethesda, MD, the Department of Veterans Affairs, Veterans Health Administration, and a Department of Defense award administered through the Henry Jackson Foundation (grant no. MDA 905-03-2-0003).

    No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.

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