DÄ internationalArchive38/2016Long-term Rehabilitation in Patients With Acquired Brain Injury

Original article

Long-term Rehabilitation in Patients With Acquired Brain Injury

A Randomized Controlled Trial of an Intensive, Participation-Focused Outpatient Treatment Program

Dtsch Arztebl Int 2016; 113: 634-41. DOI: 10.3238/arztebl.2016.0634

Bender, A; Adrion, C; Fischer, L; Huber, M; Jawny, K; Straube, A; Mansmann, U

Background: Patients with acquired brain injury who have been discharged from inpatient neurological rehabilitation often continue to suffer from limited independence, participation, and quality of life. Participation-focused outpatient treatment (in German: teilhabeorientierte ambulante Maßnahme, TEAM) was developed to improve these patients’ outcomes.

Methods: In a randomized, controlled trial, 53 patients who had sustained an acquired brain injury approximately four years earlier were allotted to two different sequences of treatment (26 TEAM/control, 27 control/TEAM). The primary endpoint was the achievement of an individual participation goal one month after the start of treatment. The secondary endpoints included independence in everyday activities, health-related quality of life, participation, and need for nursing care. The intervention was four weeks long and was carried out on an outpatient basis (19.4 ± 1.3 hours per week). Patients in the control group were treated in a manner resembling usual current care. All endpoints were evaluated in a per-protocol (PP) analysis of data from 47 patients. For confirmation, an intention-to-treat (ITT) analysis was also carried out for the primary endpoint and for independence in everyday activities.

Results: According to the PP analysis, TEAM patients achieved their individual participation goals at 1 month more frequently than control patients receiving standard treatment (61% vs. 21%; p = 0.008) and improved more with respect to independence in everyday activities. The difference between TEAM and standard treatment was +7.3 points on the FIM (Functional Independence Measure) scale (95% confidence interval [2.8; 11.8]; p = 0.0024). The superiority of TEAM was confirmed by the ITT analysis (achievement of the participation goal, TEAM vs. standard treatment: 54% vs. 19%, p = 0.0103). Moreover, improvements were seen at 12 months in quality of life, participation, and the need for nursing care.

Conclusion: The TEAM rehabilitation program can help patients in the chronic phase of acquired brain injury achieve participation goals that are relevant to everyday life. An adjustment of the care structure in Germany to include such intensive goal-oriented rehabilitation programs would lead to a more effective mobilization of these patients’ potential for long-term rehabilitation.

LNSLNS

Acquired brain injury, such as stroke or traumatic brain injury (TBI), is one of the most common causes of long-term disability. It is associated with loss of quality of life and substantial economic costs (1). Annual incidence rates are 262 per 100 000 population per year for TBI and 217 per 100 000 population for ischemic cerebral infarction, giving an estimate of approximately 380 000 new cases per year in Germany. Even ignoring milder cases with complete remission, there are hundreds of thousands of affected individuals living with the resulting disabilities (2, 3).

For moderate and serious injury, the most effective neurological rehabilitation possible is needed to prevent or reduce long-term disability. In Germany, such rehabilitation is established in a multiphase model according to the recommendations of the Federal Rehabilitation Working Group (BAR, Bundesarbeitsgemeinschaft Rehabilitation) (4). However, in recent years the duration of patients’ stays in inpatient neurological early rehabilitation (BAR phase B) has shortened, from a mean of 47 days in 2005 to 38 days in 2008. This means that patients are being discharged home or to a facility earlier and earlier (5, 6). After inpatient rehabilitation has ended, participation and quality of life often remain considerably restricted, and assistance and care are required (6). For example, 78% of former early rehabilitation patients are registered disabled, and 51% are allocated a tier of nursing care. Only 8.5% report that their daily lives are not restricted at all (6).

In the multiphase model, neurorehabilitation is coordinated and goal-focused, and is provided by an interdisciplinary rehabilitation team which takes into account factors concerning health, life situation, and context using the WHO International Classification of Functioning, Disability and Health (ICF) (7). In contrast, outpatient care (e.g. physiotherapy, occupational therapy, speech therapy) often fragments into individual, function-focused components that are not united in an overall treatment strategy.

In this article we report on the findings of a randomized controlled clinical trial in which patients with acquired brain injury in a chronic phase underwent treatment for 4 weeks. During the intervention period of the trial, patients were treated in a participation- and goal-focused interdisciplinary outpatient neurorehabilitation program while during the control period, patients recieved current standard outpatient care.

Methods

This was a single-center, randomized, controlled, investigator-blinded trial with 6 trial visits. Although it was planned and conducted as a crossover study, as a result of carryover effects statistical evaluation was performed as for a conventional parallel-group study, using data from the first treatment period (eMethods) (8). The first treatment period lasted one month and was followed by a 2-month washout phase. The treatments were then switched, and a final visit was held at 12 months (eFigure 1). The trial was approved by the ethics committee of the Faculty of Medicine at Ludwig-Maximilian University Munich. It was entered in the German Clinical Trials Register (DRKS, Deutsches Register Klinischer Studien) after it had begun (trial ID: DRKS00009602).

TEAM trial design and conduct
eFigure 1
TEAM trial design and conduct

Patients

Fifty-four chronic-phase patients who had suffered serious acquired brain injury (ischemic cerebral infarction, intracerebral hemorrhage, subarachnoid hemorrhage, TBI) were enrolled in the trial due to persistent disability and participation restriction; 53 were randomized to the 2 treatment orders, at a ratio of 1:1. One patient was excluded between enrolment and randomization as travel could not be arranged (CONSORT flow diagram, eFigure 2). The principal inclusion criteria were as follows:

CONSORT flow diagram
eFigure 2
CONSORT flow diagram
  • Cerebral infarction (hemorrhage or ischemia) or TBI 6 months or more ago
  • Time from discharge from inpatient rehabilitation treatment to trial enrolment 3 months or more
  • Age 18 to 85 years.

Trial intervention

The treatment phase lasted 4 weeks. The aim was for patients and their relatives to learn to deal with specific everyday challenges in the ICF domains self-care, home life, and mobility using a participation-focused outpatient program known as TEAM in line with its initials in German. Before randomization, during the initial visit at home, the patients and their relatives set a specific 4-week rehabilitation goal.

The TEAM intervention was conducted on an outpatient basis for 6 hours every weekday for 4 weeks, at the Burgau Treatment Center (TZB, Therapiezentrum Burgau). The 6 hours consisted of 2.5 hours of individual therapy, 1.5 hours of group therapy, and a one-hour set break. There were 2 meals, with therapeutic supervision, per treatment day. The treatment team was interdisciplinary (nurse and doctor, occupational therapist, physiotherapist, speech therapist, social service provider, technical aid advisor, neuropsychologist). A majority of therapy hours involved the use of Affolter tactual interaction therapy (9, 10). The TEAM intervention also integrated relatives closely, and evaluated patients in their real home environment.

In the control group, patients received standard outpatient treatment as they had before the trial. Those providing this treatment were informed of the patients’ trial participation and told, in particular, of the patients’ specific 4-week rehabilitation goals toward which they were to work.

Assessments and measuring tools

The primary outcome was defined as the extent of individual goal attainment. The tool used to measure this was goal attainment scaling (GAS). This characterizes the extent to which an individual target is attained using 5 levels, ranging from –2 (worse than initially) to +2 (better than planned), and makes it possible to quantify different patient-specific goals so that they can be compared with each other in rehabilitation research (case study in eBox) (11, 12).

Case study
eBox
Case study

The following measuring tools were also used:

  • The Functional Independence Measure (FIM) (13, 14)
  • EuroQol (EQ-5D: health-related quality of life [QoL]) (15)
  • Short-Form 36 (SF-36: self-evaluation QoL questionnaire) (16)
  • The WHO Disability Assessment Schedule (WHODAS: evaluation of changes in health, participation, and disability) (17)
  • The German New Appraisal Assessment: Nursing Care (analyzes patients’ resources to determine their care needs)
  • The Caregiver Strain Index (CSI) (18).

The modified Rankin Scale (mRS) was used for clinical characterization of the trial population on initial examination. Because this allows for only very rough outcome evaluation, mRS findings were not analyzed later in the trial (details on the measuring tools used can be found in the eMethods section).

Statistical evaluation

Both the GAS for the primary outcome and the other measuring tools underwent per-protocol analysis after the 4-week intervention (first treatment period). For GAS and FIM, intention-to-treat evaluation was also performed as a sensitivity analysis. This included dropouts. The statistical methods used and further information on the trial design are detailed in the eMethods section.

Results

Fifty-three patients were randomized to the two treatment orders (26 patients to the trial intervention followed by standard treatment in the control phase, 27 to standard treatment followed by the trial intervention). Forty-seven patients (23 in the TEAM group, 24 in the control group) completed the trial according to the schedule and were defined as the population to be analyzed in the per-protocol analysis. In addition, intention-to-treat analysis was performed for GAS and FIM (eMethods). There were no differences between the 2 groups at the beginning of the trial in terms of either demographics or health- and illness-related factors (Table 1).

Demographic and health-related factors at beginning of trial, before randomization, for intention-to-treat population*
Table 1
Demographic and health-related factors at beginning of trial, before randomization, for intention-to-treat population*

During the TEAM phases patients received 19.4 ± 1.3 (mean [M] ± standard deviation [SD]) hours of treatment per week. This was split into 6.4 hours of occupational therapy, 4.0 hours of physiotherapy, 1.7 hours of speech therapy, and 7.3 hours of group therapy focusing on everyday activities. During the control phase patients received their standard treatment. This was 2.2 ± 0.9 hours (M ± SD) of physiotherapy, 1.8 ± 1.0 hours of occupational therapy, and 1.2 ± 1.1 hours of speech therapy.

Results of the randomized controlled trial phase

In the TEAM group, 61% (14/23) of patients had achieved their individual goals by the end of the one-month initial treatment phase, versus only 21% (5/24) in the control group (p = 0.008; Fisher’s exact test for differences between rates; number needed to treat (NNT) = 1/0.400 = 2.5 [1.564; 12.827]).

In independence in daily activities, over the same period there was a significant increase in FIM score from 88.25 ± 22.99 (M ± SD) to 95.86 ± 16.4 in the TEAM group, versus 91.4 ± 18.4 to 92.2 ± 19.5 in the control group (p = 0.0003, Mann–Whitney U-test).

Both the significantly higher extent of goal attainment and the improvement in FIM for the TEAM program were confirmed in sensitivity analyses performed for all 53 randomized patients, i.e. including the 6 dropouts who had not begun the trial intervention: the figure for goal attainment was 54% [35; 72] for TEAM, versus 19% [8; 38] for standard treatment. The mean change in FIM score for TEAM was 7.40 ± 0.55, versus 0.89 ± 0.29 for standard treatment (p <0.0041, eMethods).

At 3 months (at the end of the 2-month washout phase), there were no significant differences between the TEAM program and standard treatment in terms of either the tools used to evaluate quality of life and participation or those used to assess the situation of relatives providing care (eTable 1).

Quality of life, participation, care needs, and burden on relatives at times T1 (baseline) and T3 (end of first treatment period, including 2-month washout phase)
eTable 1
Quality of life, participation, care needs, and burden on relatives at times T1 (baseline) and T3 (end of first treatment period, including 2-month washout phase)
Trial assessment schedule
eTable 3
Trial assessment schedule

Follow-up results

Twelve months after the beginning of the trial 80.9% (38/47) [66.74; 90.85] of all trial participants had achieved their original individual participation and activity goals (eFigure 3). Because of the trial’s crossover design, all patients had by now undergone the TEAM intervention. Regardless of treatment order, there were significant improvements among the trial population in the domains independence in daily activities, QoL (EQ-5D), participation, and care needs (Figure 1, Table 2).

Changes in various domains and outcomes during the one-year trial period
Figure 1
Changes in various domains and outcomes during the one-year trial period
Changes in clinical evaluation scales in parallel-group analysis (first onemonth treatment period before crossover only) and at one-year follow-up
Table 2
Changes in clinical evaluation scales in parallel-group analysis (first onemonth treatment period before crossover only) and at one-year follow-up
Goal attainment
eFigure 3
Goal attainment

Examination of FIM alone shows that independence improved significantly during TEAM treatment with both treatment orders (Figure 2).

Changes in FIM (&#916;FIM) during trial, from initial value at beginning of trial, by treatment group.
Figure 2
Changes in FIM (ΔFIM) during trial, from initial value at beginning of trial, by treatment group.

Complications during TEAM treatment

There were a total of 4 falls during TEAM treatment. The most common reason for medical consultations and treatments during TEAM treatment was adjustment of blood pressure medication, in most cases due to hypertensive values.

Discussion

In this randomized, controlled, investigator-blinded clinical trial, we were able to demonstrate that a participation-focused, intensive rehabilitation program lasting only 4 weeks enabled patient-specific goals highly relevant to everyday life to be attained more frequently than standard outpatient care, even among patients with serious acquired brain injury sustained a mean of 4 years previously. This is important because during such a chronic phase it is normally assumed that there will be a plateau rather than further dynamic improvement (19). However, other studies of rehabilitation interventions have already shown that significant functional or activity-related gains remain possible more than 6 months after brain injury (20, 21). Even the rather crude FIM tool to describe functional independence in daily activities showed small but significant improvements for the TEAM treatment. After the crossover, patients in the group receiving TEAM first and standard treatment second were able to maintain their progress and even build on it over 12 months. In contrast, the patients who received standard treatment first and TEAM second did not improve until they were undergoing the TEAM treatment, including in independence in daily activities. This can be seen as further evidence of the efficacy of the trial intervention (Figure 2).

Assessments/Measuring tools to test hypothesis
eTable 2
Assessments/Measuring tools to test hypothesis

The special feature of this trial is its focus on attainment of a predefined, participation-related goal relevant to everyday life and its verification of goal attainment in the real home environment. There have already been multiple clinical studies of rehabilitation showing that specific measures can attain functional and activity-related improvements even in chronic patients, such as constraint-induced movement therapy for arm and hand function (22), robotic arm and hand training (2325), task-specific arm and hand training (26), and intensive speech therapy combined with transcranial magnetic stimulation (27). However, many of these studies were not controlled or used only very small case numbers, and patients’ individual living environments were not taken into account when their results were measured. This latter seems to us to be a decisive aspect of patients’ post-clinical long-term rehabilitation.

Several of our trial participants had also achieved functional and activity-related gains during standard outpatient treatment, but they were unable to use these gains in their real home environments (see eBox for case study). This corresponds to the logic of the ICF, which works on the basis that actual participation in life is governed not only by the severity of the damage sustained and resulting disability but also, and substantially, by the resources available to the patient and his/her environment or the hindering factors in these areas (28). Comprehensive rehabilitation programs should attach sufficient importance to all these factors in chronic-phase patients.

Participation-focused treatment has also been performed in other studies of rehabilitation, for example in a smaller, uncontrolled case series of 12 chronically ill stroke patients (29). In this study participation improved steadily over a 5-month observation period. There were similar findings in a nonrandomized trial involving 83 stroke patients, 27 of whom took part in a special outpatient treatment program (30). The participation of patients in the intervention group improved significantly in comparison to untreated patients. This is in line with the results we present here and illustrates that participation-focused intensive treatment programs can be successful even in chronic-phase patients.

After 12 months our trial patients achieved increased participation, reduced care needs, greater independence, and better health-related quality of life than at baseline. However, because this was a crossover trial, all patients received a one-month therapeutic intervention, so the trial could not examine whether the positive changes were due to the TEAM intervention. Nevertheless, the long-term positive improvements in quality of life are significant, as many earlier longitudinal studies had shown that after an improvement within the first 6 months quality of life did not improve further even after years (31, 32).

Whether such long-term rehabilitation programs may also be worthwhile in terms of health economics should be clarified in future pilot projects. Lesser care needs and greater independence in daily life may lead to a lessening of the burden on the social insurance system in multiple sectors in Germany.

The finding that there is long-term potential for rehabilitation following acquired brain injury may sound ominous to those who provide funding, but it may have major implications for care in Germany, where this potential as yet remains almost untapped. Care after acquired brain injury is currently characterized by isolated function-focused, individual treatment components provided too infrequently. There is often no coordination of these individual treatment components, which are undoubtedly performed very skillfully and with the best of intentions; primary care physicians and neurologists in private practice in particular are often unable to cope with the resulting workload through no fault of their own. Specific essentials such as determining which technical aids are required or advice on social services are usually completely absent. In addition, experienced rehabilitation physicians are usually no longer involved at all in this phase of recovery, which often lasts for decades. However, the uncoordinated prescription of treatment and aids, performed with the best of intentions, leads to high costs even though they do not allow patients to achieve as many concrete goals as focused treatment programs (Figure 3a). On the basis of the scientific evidence, it would be far more sensible to treat patients at regular intervals with further intensive rehabilitation programs in order to achieve their next goals which are relevant to their everyday lives (Figure 3b). We have previously been able to show that a similar approach with very seriously affected patients receiving inpatient rehabilitation at intervals can still result in significant improvements even after several years (33). The core features of the post-clinical rehabilitation program for chronic-phase patients presented here correspond in broad terms to the recommendations recently formulated by Germany’s Federal Rehabilitation Working Group (BAR) for phase E of neurological rehabilitation (34). A comprehensive care structure should be put in place for this area as swiftly as possible.

Attainment of independence and partic ipation goals in daily life following acquired brain injury in relation to therapy and care structure
Figure 3
Attainment of independence and partic ipation goals in daily life following acquired brain injury in relation to therapy and care structure

Limitations

One limitation we must acknowledge is that the design of this trial did not allow us to investigate whether or not the content of the TEAM rehabilitation program was more effective than other therapies; this would have required a control group receiving treatment at the same frequency but with different content. An apparent contradiction in the findings of our trial is that although the number of individual patient goals achieved using the TEAM treatment was statistically significantly greater, this seems to have had no effect on generic measuring tools for health-related quality of life (EQ-5D, SF-36) or participation (WHODAS) at the end of the first treatment period, at one month. However, measuring quality of life and participation in neurological patients is difficult, particularly when generic and general measuring tools are used (35). Attainment of specific everyday goals may lie below the sensitivity threshold of the measuring procedure. Intention-to-treat analysis was performed only to confirm the extent of individual goal attainment.

Funding/sponsorship
This trial was sponsored pro rata by the German Federal Ministry of Health (BMG, Bundesministerium für Gesundheit) as a pilot project, using third-party funds. We are very grateful for this support.

Acknowledgement
We would like to thank all the patients who took part in this trial, as well as Dr. med. Dipl.-Inform. Thomas Müller of the Institute for Medical Information Processing, Biometrics, and Epidemiology (IBE, Institut für medizinische Informationsverarbeitung, Biometrie und Epidemiologie) of the University of Munich for IT management processing of the trial database.

Conflict of interest statement
Prof. Bender, Luzia Fischer, Dr. Huber, and Kerstin Jawny are staff physicians in a neurological rehabilitation facility that provides a corresponding commercial outpatient rehabilitation program.

Prof. Bender has received reimbursement of travel expenses and event fees from Bayer, and a lecture fee from Covidien. He receives material resources for a research project from Hocoma and Hasomed.

Christine Adrion, Prof. Mansmann, and Prof. Straube declare that no conflict of interest exists.

Manuscript received on 18 February 2016, revised version accepted on 21 June 2016.

Translated from the original German by Caroline Shimakawa-Devitt, M.A.

Corresponding author:
Prof. Dr. med. Andreas Bender
Burgau Treatment Center
Kapuzinerstr. 34
89331 Burgau
Germany
a.bender@therapiezentrum-burgau.de

@Supplementary material
For eReferences please refer to:
www.aerzteblatt-international.de/ref3816

eMethods, eBoxes, eFigures, eTables:
www.aerzteblatt-international.de/16m0634

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Department of Neurology, Therapiezentrum Burgau:
Prof. Dr. med. Bender, Luzia Fischer, Dr. med. Huber, Kerstin Jawny
Neurological Clinic and Policlinic, Großhadern Hospital, Ludwig-Maximilians-Universität München:
Prof. Dr. med. Bender, Prof. Dr. med. Straube
Institute for Medical Data Processing, Biometrics and Epidemiology (IBE),
Ludwig-Maximilians-Universität (LMU) München: Christine Adrion, MPH, Prof. Dr. rer. nat. Mansmann
Changes in various domains and outcomes during the one-year trial period
Figure 1
Changes in various domains and outcomes during the one-year trial period
Changes in FIM (&#916;FIM) during trial, from initial value at beginning of trial, by treatment group.
Figure 2
Changes in FIM (ΔFIM) during trial, from initial value at beginning of trial, by treatment group.
Attainment of independence and partic ipation goals in daily life following acquired brain injury in relation to therapy and care structure
Figure 3
Attainment of independence and partic ipation goals in daily life following acquired brain injury in relation to therapy and care structure
Demographic and health-related factors at beginning of trial, before randomization, for intention-to-treat population*
Table 1
Demographic and health-related factors at beginning of trial, before randomization, for intention-to-treat population*
Changes in clinical evaluation scales in parallel-group analysis (first onemonth treatment period before crossover only) and at one-year follow-up
Table 2
Changes in clinical evaluation scales in parallel-group analysis (first onemonth treatment period before crossover only) and at one-year follow-up
Case study
eBox
Case study
TEAM trial design and conduct
eFigure 1
TEAM trial design and conduct
CONSORT flow diagram
eFigure 2
CONSORT flow diagram
Goal attainment
eFigure 3
Goal attainment
Quality of life, participation, care needs, and burden on relatives at times T1 (baseline) and T3 (end of first treatment period, including 2-month washout phase)
eTable 1
Quality of life, participation, care needs, and burden on relatives at times T1 (baseline) and T3 (end of first treatment period, including 2-month washout phase)
Assessments/Measuring tools to test hypothesis
eTable 2
Assessments/Measuring tools to test hypothesis
Trial assessment schedule
eTable 3
Trial assessment schedule
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