Does routine follow up after head injury help? A randomised controlled trial. Cognitive rehabilitation for traumatic brain injury: A randomized trial. Defense and Veterans Head Injury Program (DVHIP) Study Group. A randomised controlled trial to determine the effect of intensity of therapy upon length of stay in a neurological rehabilitation setting. Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial. Remedial therapy after stroke: a randomised controlled trial. Routine follow up after head injury: a second randomised controlled trial. Neuropsychological rehabilitation for traumatic brain injury: do carers benefit? Effectiveness of an intensive outpatient rehabilitation program for postacute stroke patients. Mild traumatic brain injuries: the impact of early intervention on late sequelae. A randomized controlled trial. Community based rehabilitation after severe traumatic brain injury: a randomised controlled trial. Comparing stroke rehabilitation outcomes between acute inpatient and nonintense home settings. A randomized trial of two treatments for mild traumatic brain injury. Traumatic brain injury: efficacy of multidisciplinary rehabilitation. Does a short period of rehabilitation in the home setting facilitate functioning after stroke? A randomized controlled trial. The effects of increased rehabilitation therapy after brain injury: results of a prospective controlled trial.
To evaluate the Medical Disability Society's 1988 recommendation that "every patient attending hospital after a head injury should be registered and offered an outpatient follow up appointment" by determining whether offering a routine follow up service to patients presenting to hospital with a head injury of any severity affects outcome six months later.
                A randomised controlled trial design with masked assessment of outcome.
                A mixed rural and urban health district with a population of about 560000.
                1156 consecutive patients resident in Oxfordshire aged between 16 and 65 years presenting over 13 months to accident and emergency departments or admitted to hospital and diagnosed as having a head injury of any severity, including those with other injuries.
                Patients were registered and randomised to one of two groups. Both groups continued to receive the standard service offered by the hospitals. The early follow up group were approached at 7-10 days after injury and offered additional information, advice, support, and further intervention as needed. All randomised patients were approached for follow up assessment six months after injury by independent clinicians blind to their group.
                Validated questionnaires were used to elicit ratings of post-concussion symptoms (the Rivermead postconcussion symptoms questionnaire), and changes in work, relationships, leisure, social, and domestic activities (the Rivermead head injury follow up questionnaire).
                The two groups were comparable at randomisation. Data was obtained at six months on 226 of 577 "control" patients and 252 of 579 "trial" patients (59% were lost to follow up). There were no significant differences overall between the trial and control groups at follow up, but subgroup analysis of the patients with moderate or severe head injuries (posttraumatic amnesia > or = one hour, or admitted to hospital), showed that those in the early intervention group had significantly fewer difficulties with everyday activities (P = 0.03).
                The results from the 41% of patients followed up do not support the recommendation of offering a routine follow up to all patients with head injury, but they do suggest that routine follow up is most likely to be beneficial to patients with moderate or severe head injuries. Some of those with less severe injuries do continue to experience difficulties and need access to services. A further trial is under way to test these conclusions. Traumatic brain injury (TBI) is a principal cause of death and disability in young adults. Rehabilitation for TBI has not received the same level of scientific scrutiny for efficacy and cost-efficiency that is expected in other medical fields.
                To evaluate the efficacy of inpatient cognitive rehabilitation for patients with TBI.
                Single-center, parallel-group, randomized trial conducted from January 1992 through February 1997 at a US military medical referral center.
                One hundred twenty active-duty military personnel who had sustained a moderate-to-severe closed head injury, manifested by a Glasgow Coma Scale score of 13 or less, or posttraumatic amnesia lasting at least 24 hours, or focal cerebral contusion or hemorrhage on computed tomography or magnetic resonance imaging.
                Patients were randomly assigned to an intensive, standardized, 8-week, in-hospital cognitive rehabilitation program (n=67) or a limited home rehabilitation program with weekly telephone support from a psychiatric nurse (n=53).
                Return to gainful employment and fitness for military duty at 1-year follow-up, compared by intervention group.
                At 1-year follow-up, there was no significant difference between patients who had received the intensive in-hospital cognitive rehabilitation program vs the limited home rehabilitation program in return to employment (90% vs 94%, respectively; P=.51; difference, 4% [95% confidence interval ¿CI¿, -5% to 14%]) or fitness for duty (73% vs 66%, respectively; P=. 43; difference, 7% [95% CI, -10% to 24%]). There also were no significant differences in cognitive, behavioral, or quality-of-life measures. In a post-hoc subset analysis of patients who were unconscious for more than 1 hour (n = 75) following TBI, the in-hospital group had a greater return-to-duty rate (80% vs 58%; P=. 05).
                In this study, the overall benefit of in-hospital cognitive rehabilitation for patients with moderate-to-severe TBI was similar to that of home rehabilitation. These findings emphasize the importance of conducting randomized trials to evaluate TBI rehabilitation interventions. JAMA. 2000;283:3075-3081 A randomised single-blind controlled trial was designed to determine whether intensity of therapy (physiotherapy and occupational therapy) shortened length of stay for patients in a rehabilitation unit. Patients were under 65, primarily with stroke, but also with other conditions such as traumatic brain injury, and multiple sclerosis. The experimental group were timetabled to receive 67% more therapy in any given week, than the control group. After controlling for confounders and case mix (as expressed by type of therapy required) patients in the experimental group showed a significant 14-day reduction in length of stay (<0.01). Concurrently average length of stay was increased for both groups by 16 days due to delays in discharge. To evaluate the effects of an increase in the intensity of rehabilitation on the functional outcome of patients with traumatic brain injury (TBI).
                Sixty-eight patients (age 12-65 years) with moderate-to-severe TBI were included. They were randomized into high (4-hour/day) or control (2-hour/day) intensity rehabilitation programmes at an average of 20 days after the injury. The programmes ended when the patients achieved independence in daily activities or when 6 months had passed.
                No significant differences were found in the Functional Independence Measure (FIM) (primary outcome) and Neurobehavioural Cognitive Status Examination (NCSE) total scores between the two groups. There were significantly more patients in the high intensity group than in the control group who achieved a maximum FIM total score at the third month (47% vs. 19%, p = 0.015) and a maximum Glasgow Outcome Scale (GOS) score at the second (28% vs. 8%, p = 0.034) and third months (34% vs. 14%, p = 0.044).
                Early intensive rehabilitation may improve the functional outcome of patients with TBI in the early months post-injury and hence increase the chance of their returning to work early. Intensive rehabilitation in this study speeded up recovery rather than changed the final outcome. Of 1094 patients with a confirmed stroke admitted to Northwick Park, a district general hospital, 364 (33%) died while in hospital, 215 (20%) were fully recovered when discharged, and 329 (30%) were too frail or too ill from diseases other than stroke to be considered for active rehabilitation. Only 121 (11%) were suitable for intensive treatment. They and 12 patients referred direct to outpatients were allocated at random to one of three different courses of rehabilitation. Intensive was compared with conventional rehabilitation and with a third regimen which included no routine rehabilitation, but under which patients were encouraged to continue with exercises taught while in hospital and were regularly seen at home by a health visitor. Progress at three months and 12 months was measured by an index of activities of daily living. Improvement was greatest in those receiving intensive treatment, intermediate in those receiving conventional treatment, and least in those receiving no routine treatment. Decreasing intensity of treatment was associated with a significant increase in the proportions of patients who deteriorated and in the extent to which they deteriorated. Probably only a few stroke patients, mostly men, are suitable for intensive outpatient rehabilitation, but for those patients the treatment is effective and realistic. To confirm that patients admitted to hospital with a head injury benefit from a routinely offered early intervention service.
                A mixed rural and urban Health District of 560000 people with two accident and emergency departments provided the setting. Existing routine services for most patients with head injury are minimal. All patients aged 16-65 years admitted to hospital after a head injury of any severity, with or without other injuries entered the trial. Prospective randomisation, with a block randomisation procedure was used to allocate all eligible patients to either: a group offered an additional service by a specialist team; or a group receiving existing standard services. Patients were assessed at follow up six months after injury. The primary outcome measure was the Rivermead head injury follow up questionnaire, a validated and reliable measure of social disability. The Rivermead post-concussion symptoms questionnaire was used to estimate severity of post-concussion symptoms. Each patient in the trial group was contacted 7-10 days after injury, and offered assessment and interventions as needed. These initially focused on the provision of information, support, and advice. Forty six per cent of patients in the trial group also received further outpatient intervention or additional support by telephone.
                314 patients were registered: 184 were randomised into the trial group, 130 into the control group. For prognostic data, the groups were comparable at randomisation, and remained comparable when assessed at six months. 132 trial and 86 control patients were followed up at six months after injury. Patients' posttraumatic amnesia ranged from mild (n=79, 40%), and moderate (n=62, 32%), to severe (n=38, 19%) and very severe (n=17, 9%). The trial group patients had significantly less social disability (p=0.01) and significantly less severe post-concussion symptoms (p=0.02) at follow up at six months after injury than the control group patients.
                The early interventions offered by a specialist service significantly reduced social morbidity and severity of post-concussion symptoms in trial group patients at six months after head injury. Recommendations about how specialist services should be targeted are made both in the light of these results and those from a previous randomised controlled trial. This study evaluated the effectiveness of a new rehabilitation service, compared with existing services, for carers of people with traumatic brain injury (TBI). Subjects were 96 adult carers of people consecutively admitted to two local hospitals. They were assigned to one of three groups: Early new service (pre-discharge); Late new service (post-discharge); or a Control condition (existing services only). Individual randomization was not possible and randomization by hospital site was rejected because of demographic and clinical differences between sites. Group assignment was determined by a pre-specified timetable which alternated between hospitals. Two outcomes were compared at 6 months post-injury: carers' emotional distress and how well-informed they felt about TBI and available resources. Analyses adjusting for potential confounding factors confirmed a clinically plausible superior outcome for both intervention groups compared to the control group. However, these differences did not obtain statistical significance (p > or = 0.01). Several reasons for these findings are discussed, including the novelty of the new service and methodological issues such as statistical power. Longer term follow-up studies are required as psychological sequelae and, therefore, the need for intervention is known to increase with time and may not be most apparent during the first 6 months. The effectiveness of ongoing rehabilitation services for postacute stroke survivors is poorly documented. We designed a randomized control, single-blinded study to demonstrate the effectiveness of intensive outpatient therapy. The treatment intervention consisted of 1 hr each of physical and occupational therapy, four times per week, for 12 wk; therapy focused on neuromuscular facilitation and functional tasks. All subjects were screened before the therapies and after 3 mo and 9 mo. Forty-nine stroke survivors, who were at least l yr (mean, 2.9 yr) poststroke, were randomized with two treated patients to each control (no treatment supplied). All patients had received inpatient rehabilitation at the time of their acute stroke, but no patient had any ongoing therapy within the last 6 mo. The outcome measures included the Functional Independence Measure (FIM), Brunnstrom stages of motor recovery, timed mobility tasks, and the Jebson hand evaluation. We also evaluated the level of depression, self-esteem, and socialization. The treated patients demonstrated an improvement of 6.6 points over the 3 mo of therapy compared with only 1.5 points in the control group in the FIM motor score transformed using Rasch analysis. The change from time 0 to 3 mo was significant in the treated group but not in the controls. Treated patients maintained their gains at the 9-mo follow-up, and controls lost ground. The treated group improved in terms of socialization and self-esteem as evidenced by a lower Sickness Impact Profile, whereas the controls tended to get worse. There was a trend toward less depression, but this did not reach a P = 0.05 level of significance. This study demonstrates that significant functional gains can still be attained in the postacute stroke survivor, despite prior inpatient rehabilitation services. Positive results from early clinical intervention of mild traumatic brain injury (MTBI) patients by rehabilitation specialists have been reported. Various treatments have been used, but few controlled studies are published. We hypothesised that early rehabilitation of selected MTBI patients would reduce long term sequelae.
                A randomised controlled trial with one year follow-up. Among 1719 consecutive patients with MTBI, 395 individuals, 16-60 years of age, met the MTBI definition. Exclusion criteria were: previous clinically significant brain disorders and/or a history of substance abuse. The control group (n = 131) received regular care. The intervention group (n = 264) was examined by a rehabilitation specialist. 78 patients were mainly referred to an occupational therapist. The problems were identified in daily activities and in terms of post-concussion symptoms (PCS), an individualised, tailored treatment was given. Primary endpoint was change in rate of PCS and in life satisfaction at one-year follow-up between the groups.
                No statistical differences were found between the intervention and control groups. Patients who experienced few PCS two to eight weeks after the injury and declined rehabilitation recovered and returned to their pre-injury status. Patients who suffered several PCS and accepted rehabilitation did not recover after one year.
                In this particular MTBI sample, early active rehabilitation did not change the outcome to a statistically-significant degree. Further studies should focus on patients with several complaints during the first 1-3 months and test various types of interventions. Evaluation of multidisciplinary community based outreach rehabilitation after severe traumatic brain injury (TBI).
                A randomised controlled trial compared outreach treatment (mean of two sessions a week for 27.3 (SD 19.1) weeks) in community settings such as participants' homes, day centres, or workplaces, with provision of written information detailing alternative resources. Follow up for an average of 24.8 months after initial allocation was by a blinded independent assessor. Participants were aged 16-65, had sustained severe TBI between 3 months and 20 years previously, and had no other neurological conditions. Of 110 initially allocated, 48 outreach and 46 information participants were successfully followed up. Primary outcome measures (Barthel index (BI) and the brain injury community rehabilitation outcome-39 (BICRO-39)) focused on levels of activity and participation. Secondary measures were the functional independence measure and the functional assessment measure (FIM+FAM) and, in a subgroup of 46 participants, the hospital anxiety and depression scale. Analyses were non-parametric.
                outreach participants were significantly more likely to show gains on the BI and the BICRO-39 total score and self organisation and psychological wellbeing subscales. There were likewise strong trends (p<0.10) for BICRO personal care and mobility, and on the FIM+FAM for personal care and cognitive functions. Differential improvements were not seen for indices of socializing, productive employment, anxiety, or depression. Median changes on individual subscales were small, reflecting the diversity of the clinical population; however, 40% of outreach but only 20% of information participants made a clinically significant improvement of 2+ points on at least one BICRO-39 scale. Time since injury was unrelated to the magnitude of gains.
                This is the first RCT of multidisciplinary community rehabilitation after severe TBI, and suggests that even years after injury it can yield benefits which outlive the active treatment period. To compare outcomes in stroke survivors who received rehabilitation services in an acute inpatient rehabilitation setting (multidisciplinary rehabilitation team) with outcomes in survivors in a home-based setting (family caregivers, limited team supervision).
                Randomized clinical trial, with mean follow-up after 60 days.
                Inpatient rehabilitation setting and home-based settings.
                Sixty patients (age range, 43-80yr) who had a stroke between 1996 and 1999 and had been referred after medical stabilization, randomly divided into 2 groups: group 1, inpatient rehabilitation; group 2, home-based rehabilitation.
                Group 1: therapeutical and neuromuscular exercises with occupational therapy with professional supervision; group 2: conventional exercises with family caregiver and limited professional supervision.
                Spasticity was evaluated with the Ashworth Scale, motor status with Brunnstrom's stages, functional status with the FIM instrument, and cognitive status with the Mini-Mental State Examination before and after rehabilitation.
                Patients rehabilitated in acute inpatient settings had better motor, functional, and cognitive outcomes (p < .05). Spasticity changes did not differ between the groups.
                Intense inpatient rehabilitation services for stroke survivors provide significantly more favorable functional and cognitive outcomes with relatively low complications than did nonintense rehabilitation efforts in home settings.
                Copyright 2001 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation The purpose of this study was to compare an education-oriented single session treatment (SS) for mild traumatic brain injury (MTBI) to a more extensive assessment, education, and treatment-as-needed intervention (TAN). Participants were 111 adults with MTBI who were recruited from consecutive admissions to two hospital emergency wards. They were randomly assigned to either the SS or TAN modality. The groups did not differ on any demographic, injury-related, or questionnaire variable when first seen within 3 weeks of injury. The groups generally improved a similar amount and did not differ from each other on any symptom-related, functional, or vocational variables 3-4 months after their baseline session. Patient satisfaction ratings with services provided were also similar for the two groups. Brief educational intervention given soon after MTBI appears to be adequate for most MTBI survivors. To establish efficacy of a coordinated multidisciplinary rehabilitation service for severe head injury, provided at Hunters Moor Regional Rehabilitation Centre.
                A quasi-experimental design to compare treatment effects between two groups. The first group received a coordinated, multidisciplinary regional rehabilitation service; the other, a single discipline approach provided by local, district hospitals. Follow-up was for 2 years postinjury.
                Fifty-six consecutive severe head injury admissions, with an identified main caregiver, referred for rehabilitation within 4 weeks of their injury.
                The Barthel index, the Functional Independence Measure (FIM), and the Newcastle Independence Assessment Form (NIAF), a newly developed, real-life, comprehensive measure. In addition, caregivers completed the General Health Questionnaire.
                The group that received coordinated multidisciplinary rehabilitation not only demonstrated significant gains throughout the study period but also maintained treatment effect after input ended. Furthermore, caregivers of this group had significantly reduced levels of distress. The comparison group, despite initial lower injury severity and shorter hospital stay, did not demonstrate equivalent gains or any posttreatment effect.
                The results show the efficacy of a comprehensive, specialist multidisciplinary regional service. There are significant implications for service provision for people with severe traumatic head injury. To assess the effect of three weeks of rehabilitation in the home setting for younger patients with stroke with the aim of improving activity level.
                A randomized controlled study with blinded evaluations at discharge, three weeks, three months and one year after discharge.
                Home of the patient or the ordinary day rehabilitation clinic at the university hospital.
                Fifty-eight patients (median age 53 years) consecutively discharged from inpatient rehabilitation with a first occurrence of stroke participated in training directly after discharge. Intervention: Rehabilitation was given for 9 hours/week over three weeks. The home group received individually tailored training, based on the patient's needs and desires, with a focus on activities in their natural context. Support and information were also given. The intervention in the day clinic group was aimed mainly at improved functions.
                The main outcome was activity, assessed with the Assessment of Motor and Process Skill (AMPS). The impairment level was also evaluated. Costs were estimated.
                There were no significant differences between the groups on any of the four assessments. However, there seemed to be an earlier improvement on some measures (including AMPS) for the home group. For both groups there was a greater improvement on the activity level than on the impairment level. the costs of the home group were less than half of the costs of the day clinic group.
                With the present results, both rehabilitation programmes could be recommended, however, further studies are needed to define patients who may specifically benefit from the home rehabilitation programme. Costs should be taken into consideration. The objective was to investigate the effect of increased intensity of rehabilitation therapy provided to brain-injured subjects on the rate at which independence was regained and the duration of hospital admission.
                A two-centre, prospective, controlled study with random allocation to groups.
                Two district general hospitals on the south coast of England.
                Fifty-six people with moderate and severe head injury consecutively admitted to Southampton and Poole hospitals between June 1995 and September 1997.
                Increased intensity of rehabilitation therapy input without change in content.
                Subjects receiving more intensive therapy made more rapid progress and were discharged home sooner. The different intensities of therapy employed in this study showed no evidence of a 'ceiling' effect and the 'intervention group' made significantly more rapid progress on tests of dependency during the period of admission. A clear response to increased therapy input was seen in one of the centres with more rapid functional improvement and a shorter length of hospital stay. This centre already had more therapy and better community facilities. No such benefits were seen at the other centre where the intervention group had a longer hospital stay than the routine group.
                Increasing the hours per week of therapy given to adults recovering from brain injury in hospital can accelerate the rate of recovery of personal independence and result in their being discharged from hospital sooner. Increased rehabilitation therapy after brain injury is associated with enhanced functional recovery and shorter hospital stay if provided in the context of an integrated service that can provide ongoing community support. There is no evidence of any ceiling effect of therapeutic intensity beyond which no further response is observed.