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Cognitive Rehabilitation- Commercial Medical Management Guideline
Regulatory Requirements U.S. Food and Drug Administration (FDA): Cognitive rehabilitation is a procedure and, therefore, is not subject to U.S. Food and Drug Administration (FDA) regulation.
Research Evidence Background Cognitive function refers to the ability to selectively attend to information, acquire knowledge and appropriately apply knowledge. Cognitive rehabilitation involves therapies designed to help improve damaged cognitive functions such as attention, memory and learning, affect and expression, and executive functions, with the goal of improving the level of functioning in multiple life areas. There are two basic approaches to cognitive rehabilitation: restorative and compensatory cognitive rehabilitation. These two techniques can be used in combination, and can be components of a comprehensive multidisciplinary rehabilitation program that involves other forms of remediation and psychosocial therapy (Hayes, 2008).
Brain injury is defined as damage to the brain caused by externally inflicted trauma or damage due to stroke, aneurysm, anoxia, encephalitis, brain tumors, and brain toxins. Either type of injury may result in significant physical, cognitive, and psychosocial impairment in functioning and consciousness. The consequences of brain injury can be enormous, and may include a dramatic change in the life-course of the person, with profound disruption to the family, substantial loss of income, and extensive lifetime utilization of health care and community services. Although physical disability can result from brain injury, the deterioration in the cognitive abilities of the patient can be even more distressing because of the negative impact on interpersonal relationships, school, and work. Many are left with persistent motor disabilities, cognitive impairment and ongoing emotional/affective changes (NIH, 1999a; Mazaux, 1998). Cognitive rehabilitation has also been investigated for other disorders such as cerebral palsy, Down syndrome, Alzheimer's disease, attention deficit hyperactivity disorder, developmental disorders such as autism, and Parkinson's disease.
Traditional rehabilitation programs for brain injury patients include occupational and physical therapy, speech therapy, community integration, and vocational rehabilitation. In addition, cognitive rehabilitation may be a component of comprehensive brain injury treatment programs (NIH, 1999a).
Cognitive rehabilitation is defined as a set of therapies that are designed to help improve damaged intellectual, perceptual, psychomotor, and behavioral skills. The goals of cognitive rehabilitation are to enhance the person's capacity to process and interpret information and to improve the person's ability to function in all aspects of family and community life. Two different approaches are used for cognitive rehabilitation of the brain injured patient, restorative training and compensatory training.
Restorative training is based on the theory that repetitive exercise can restore lost functions. It uses methods derived from cognitive neuropsychology to focus on improving specific cognitive functions, with the goal of directing recovery of cognitive functions in the context of their premorbid organization. Attention disorders, slowing of mental processing, visual scanning, and posttraumatic Cognitive Rehabilitation- Commercial Medical Management Guideline aphasia are among the symptom domains that are believed to benefit the most from restorative methods (Mazaux, 1998; Carney, 1999).
The second approach used in cognitive rehabilitation is compensatory training, which aims to develop skills and coping strategies that allow the patient to reach functional competence in daily living despite the persistence of cognitive deficits. Coping with memory impairment is an example of this approach; persons with amnesia may be trained to develop behavioral routines that are dependent on preserved procedural memory or to use various adaptive devices to keep track of daily events and scheduled activities. Restorative and compensatory rehabilitation strategies are not mutually exclusive, and adaptive aids such as memory books and electronic paging systems may also improve certain cognitive functions, as well as help the patient cope with memory disorders (NIH, 1999a;
Coma (or sensory) stimulation is proposed to promote awakening of brain-injured patients from a coma or vegetative state. This may involve stimulation of any or all of the senses with various stimuli for each sense. There is not an established protocol for completing this type of stimulation or definitive patient selection criteria.
Research Brain Injury Earlier research by Ruff and Neiman (Ruff, 1990), Neistadt (Neistadt, 1992), Novak et al. (Novack, 1996), and Salazar (Salazar, 2000) indicated that there was not a significant difference between the control and treatment groups who had completed cognitive rehabilitation. Ruff and Neiman did find that that there was less depression in the treatment group (Ruff, 1990). Neistadt noted there was no significant difference between the restorative and compensatory types of cognitive rehabilitation (Neistadt, 1992). Cicerone (2000) concluded in a meta-analysis of literature that the evidence supported the effectiveness of several forms of cognitive rehabilitation (Cicerone, 2000).
Levine et al. completed a small randomized trial comparing a structured protocol for goal management training with motor skill training. Although the sample size was small (n=30), in all six outcome measures, the group treated with goal management training showed more improvement and less decline that the motor skills group. Four of the 6 comparisons were statistically significant (Levine, 2000).
A larger (n=110) randomized controlled trial was completed by Powell et al. that compared community based cognitive rehabilitation with a group that had limited support. Outcome measures included ability to engage in ADL, level of activity participation and overall psychological functioning. The treatment group had greater improvement in most functional areas and less depression and anxiety than did the limited support group (Powell, 2002).
Cicerone et al. completed a nonrandomized prospective study of a comprehensive program versus Cognitive Rehabilitation- Commercial Medical Management Guideline standard rehabilitation. Outcome measures included the level of community integration and functioning. The treatment group had greater community integration and independent functioning than did the standard rehabilitation group (Cicerone, 2004).
Cochrane Reviews: There is some indication that training improves alertness and sustained attention but no evidence to support or refute the use of cognitive rehabilitation for attention deficits to improve functional independence following stroke (Lincoln et al., 2000). There is insufficient evidence to support or refute the effectiveness of cognitive rehabilitation for memory problems after stroke. There is a need for better-designed trials of memory rehabilitation using common standardized outcome measures (Nair and Lincoln, 2007). Several types of neglect specific approaches are described but there is insufficient evidence to support or refute their effectiveness at reducing disability and improving independence. They can alter test performance and warrant further investigation in randomized trial (Bowen and Lincoln, 2007).
Westerberg et al. (2007) conducted a randomized pilot study of 18 stroke patients who were randomized to a treatment group (computerized training on working memory tasks) and passive control group. More than 1 year after stroke, working memory training improved working memory and attention.
A 1999 National Institutes of Health (NIH) Consensus Statement on the rehabilitation of persons with traumatic brain injury noted that the available evidence, although limited, supports the use of certain cognitive and behavioral rehabilitation strategies for individuals with brain damage. This document also states that rehabilitation services should be matched to the needs of individual, and that community-based non-medical services are required to optimize outcomes over the course of recovery (NIH, 1999b).
The Agency for Healthcare Research and Quality (AHRQ) produced an evidence report on cognitive rehabilitation for traumatic brain injury. This report noted that there was no evidence from comparative studies either for or against early rehabilitation in patients with mild and moderate injury.
The report went on to state that the evidence was insufficient to define appropriate treatment protocols or to establish the value of memory aid devices. In addition, there was limited evidence that employment can improve the vocational outcomes of TBI survivors. The efficacy of case management in the treatment of TBI patients was also evaluated, with the conclusion that there is evidence that case management can lead to functional improvements, although some study results were conflicting. A subsequent evidence report that focused specifically on cognitive rehabilitation in children and adolescents concluded that clinical studies with designs capable of providing evidence for the effectiveness of interventions for children and adolescents with TBI were lacking (Carney, 1999b; Chestnut, 1999).
A systematic review by the Brain Injury Interdisciplinary Special Interest Group of the American Congress of Rehabilitation Medicine (ACRM) concluded that there is some evidence of the Cognitive Rehabilitation- Commercial Medical Management Guideline effectiveness of several forms of cognitive rehabilitation for persons with TBI. This paper went on to make specific recommendations for remediation of attention, memory, functional communication, and executive functioning after TBI (Cicerone, 2000).
BlueCross BlueShield Association Technology Evaluation:Technology Evaluation Center (TEC) Association Cognitive Rehabilitation for Traumatic Brain Injury in Adults (2008) The 2008 update of the technology assessment concluded that the number of clinical trials is relatively small. Many of the studies suffer from small sample sizes, insufficient follow-up, and lack of assessment of health outcomes. Only the nonrandomized study shows benefits of cognitive rehabilitation in terms of health outcomes. Most of the randomized studies do not show an improvement in health outcomes after a program of cognitive rehabilitation. Based on the above, cognitive rehabilitation for traumatic brain injury in adults does not meet the TEC criteria.
Comatose Patients Ellis and Rader reviewed various theories and studies on the effectiveness of sensory stimulation for minimally responsive comatose patients. They state that the operational definitions of states of altered consciousness are not consistent and ranges from clouding of consciousness, delirium to persistent vegetative state. The conclude that several factors complicate the issue of structured sensory stimulation for patients including outcome measures used across studies have not been equivalent, levels of severity of injury and responsiveness vary across studies and that the evidence suggests sensory stimulation affects different patients differently (Ellis, 1990).
A Cochrane systematic review of sensory stimulation of brain-injured patients in coma or vegetative state was completed. This study included randomized and nonrandomized controlled trials. A very small number of studies met the inclusion criteria and had poor quality of methodology and study design. The Cochrane Review concluded that due to the diversity in reporting outcome measures, no reliable evidence to support the effectiveness of multisensory stimulation programs in comatose patients could be found (Lombardi, 2002).
The largest volume of research has been conducted on the middle band of brain injured patients, namely those with significant impairments but a clear ability to improve. Less progress has been made on the two extremes of the severity spectrum. Individuals in the PVS experience diminishing odds of significant recovery as time passes. Coma stimulation therapies have been recommended, but none of these has been definitely tested for efficacy (Wilson, 1993; Zasler, 1991).
Other Disorders Cognitive rehabilitation has also been investigated for disorders such as cerebral palsy, Down syndrome, Alzheimer's disease, attention deficit hyperactivity disorder, developmental disorders such as autism, and Parkinson's disease. There is little evidence that cognitive rehabilitation is beneficial for these conditions.
Cognitive Rehabilitation- Commercial Medical Management Guideline
Farina et al. (2006) evaluated the efficacy of two different group procedures of non-pharmacological treatment in mild-to-moderate Alzheimer's disease (AD). Thirty-two patients entered the study and were divided in groups of four subjects. Recreational activities ('global' stimulation) was compared with a combination of procedural memory training on activities of daily living and neuropsychological rehabilitation of 'residual' functions ('cognitive-specific'). At follow-up (six months later), compared with baseline, patients following the 'global' stimulation treatment showed an improvement at caregiver distress on Neuropsychiatric Inventory (NPI). No other significant difference was detected. The investigators concluded that a "global' treatment can lead to a significant improvement in AD patients, both for behavioral and functional aspects. The 'cognitive-specific' treatment that was used did not show better efficacy.
Sitzer et al. (2006) systematically reviewed the literature and summarized the effect of cognitive training (CT) for Alzheimer's disease (AD) patients. Effect sizes were calculated for 17 controlled studies identified through a comprehensive literature review. An overall effect size of 0.47 was observed for all CT strategies across all measured outcomes. The investigators concluded that CT shows promise in the treatment of AD, but further research is needed to evaluate the effect of treatment on function.