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A randomized controlled trial of holistic neuropsychologic rehabilitation after traumatic brain injury
Cicerone KD, Mott T, Azulay J, Sharlow-Galella MA, Ellmo WJ, Paradise S, Friel JC
Archives of Physical Medicine and Rehabilitation 2008 Dec;89(12):2239-2249
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate the effectiveness of comprehensive, holistic neuropsychologic (NP) rehabilitation compared with standard, multidisciplinary rehabilitation for people with traumatic brain injury (TBI). DESIGN: Randomized practical controlled trial. SETTING: Postacute brain injury rehabilitation center within a suburban rehabilitation hospital. PARTICIPANTS: Participants with TBI were recruited from clinical referrals and referrals from the community. Sixty-eight participants who met inclusion criteria were randomly allocated to treatment conditions. Most participants (88%) had sustained moderate or severe TBI, and greater than half (57%) were more than 1 year postinjury at the beginning of treatment. INTERVENTIONS: Treatment was conducted 15 hours per week for 16 weeks. Standard neurorehabilitation consisted primarily of individual, discipline specific therapies (n = 34). Intensive cognitive rehabilitation emphasized the integration of cognitive, interpersonal, and functional interventions within a therapeutic environment (n = 34). MAIN OUTCOME MEASURES: Primary outcomes were the Community Integration Questionnaire (CIQ) and Perceived Quality of Life scale (PQOL). Secondary outcomes included NP functioning, perceived self-efficacy, and community-based employment. RESULTS: NP functioning improved in both conditions. Intensive cognitive rehabilitation participants showed greater improvements on the CIQ (effect size (ES) 0.59) and PQOL (ES 0.30) as well as improved self-efficacy for the management of symptoms (ES 0.26) compared with standard neurorehabilitation treatment. These gains were maintained at the 6-month follow-up. Standard neurorehabilitation participants showed improved productivity at the 6-month follow-up associated with the need for continued rehabilitation. CONCLUSIONS: Improvements seen after intensive cognitive rehabilitation may be related to interventions directed at the self-regulation of cognitive and emotional processes and the integrated treatment of cognitive, interpersonal, and functional skills. The results show the effectiveness of comprehensive holistic NP rehabilitation for improving community functioning and quality of life after TBI compared with standard rehabilitation.

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