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Research Reports |
T Ellis, PT, PhD, NCS, is Clinical Associate Professor, Department of Physical Therapy and Athletic Training, Sargent College of Health and Rehabilitation Sciences, Boston University, 635 Commonwealth Ave, Boston, MA 02215; Associate Director of Clinical Care, Center for Neurorehabilitation, Boston, Mass; and Physical Therapist and Clinical Research Scientist, Braintree Rehabilitation Hospital, Braintree, Mass.
DI Katz, MD, is Associate Professor, Department of Neurology, School of Medicine, Boston University, and Director, Brain Injury Program, Department of Neurology, Braintree Rehabilitation Hospital.
DK White, PT, ScD, NCS, is Postdoctoral Research Fellow, Clinical Epidemiology Research Training Unit, School of Medicine, Boston University.
TJ DePiero, MD, is Assistant Professor, Department of Neurology, School of Medicine, Boston University, and Medical Director, Stroke Program, Department of Neurology, Braintree Rehabilitation Hospital.
AD Hohler, MD, is Assistant Professor, Department of Neurology, School of Medicine, Boston University, and Staff Neurologist, Department of Neurology, Braintree Rehabilitation Hospital.
M Saint-Hilaire, MD, FRCPC, is Assistant Professor, Department of Neurology, School of Medicine, Boston University, and Medical Director of the Parkinson Disease Program, Department of Neurology, Braintree Rehabilitation Hospital.
Address all correspondence to Dr Ellis at: tellis{at}bu.edu
Submitted September 11, 2007;
Accepted February 26, 2008
| Abstract |
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Subjects: Sixty-eight subjects with a diagnosis of PD were admitted to an inpatient rehabilitation hospital with a multidisciplinary movement disorders program.
Methods: Subjects participated in a rehabilitation program consisting of a combination of physical therapy, occupational therapy, and speech therapy for a total of 3 hours per day, 5 to 7 days per week, in addition to pharmacological adjustments based on data collected daily. A pretest-posttest design was implemented. The differences between admission and discharge scores on the Functional Independence Measure (FIM) (total, motor, and cognitive scores), Timed "Up & Go" Test, 2-Minute Walk Test, and Finger Tapping Test were analyzed.
Results: An analysis of data obtained for the 68 subjects admitted with a diagnosis of PD revealed significant improvements across all outcome measures from admission to discharge. Subjects with PD whose medications were not adjusted during their admission (rehabilitation only) (n=10) showed significant improvements in FIM total, motor, and cognitive scores. Improvements exceeded the minimal clinically important difference in 71% of the subjects. Prior level of function at admission accounted for 20% of the variance in the FIM total change score.
Discussion and Conclusion: The results suggest that subjects with a diagnosis of PD as a primary condition benefited from an inpatient rehabilitation program designed to improve functional status.
| Introduction |
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Although a Cochrane review1 of randomized controlled trials (RCTs) reported that there is insufficient evidence to support or refute the efficacy of physical therapy in PD, a number of intervention studies have found positive effects of physical therapy in addition to medication therapy (MT) in people with PD of Hoehn and Yahr stage II or III. A meta-analysis of 12 studies (RCTs and quasi-experimental designs) investigating the effects of physical therapy in addition to MT in people with PD demonstrated significant summary effect sizes with regard to ADL (0.40), stride length (0.46), and walking speed (0.49).2 A meta-analysis of 16 studies investigating the effects of occupational therapy for people with PD revealed significant summary effect sizes for outcomes classified at the capabilities and abilities level (0.5) and the activities and tasks level (0.54).3 A large-scale RCT (conducted after the Cochrane review) investigating the efficacy of physical therapy plus MT interventions in people with PD revealed significant differences between groups in the areas of comfortable walking speed, ADL, and QOL related to physical mobility.4 Effect sizes in this RCT were consistent with those reported in the 2 meta-analyses described above.
The impact of rehabilitation may be greater if implemented in an inpatient setting. In the outpatient environment, it becomes increasingly challenging to make optimal changes in medication regimens with a brief visit to the neurologist. Patients symptoms become more complex (dyskinesia, freezing, motor fluctuations, hallucinations, and loss of postural control) and difficult to manage as the disease progresses. Observation time is limited, and neurologists must rely on patients reports for information on the type, timing, and duration of symptoms. The inpatient environment, however, may be a viable alternative in which selected patients with a primary diagnosis of PD can receive effective management when they experience more complex symptoms, a decline in function, or frequent falls or are in jeopardy of losing their independence. With admission to an inpatient multidisciplinary rehabilitation hospital, patients can participate in daily therapies in an environment that allows continuous monitoring of functional status and medication response by a team that is knowledgeable about movement disorders. Although patients with PD often are admitted to an inpatient rehabilitation program following an orthopedic, cardiopulmonary, or general medical procedure (secondary diagnosis of PD), patients with PD as the primary diagnosis are not typically referred for inpatient rehabilitation.
The purposes of this study were to determine whether people with a diagnosis of idiopathic PD as a primary condition showed improvements in functional status following participation in a specialized inpatient multidisciplinary rehabilitation program and to determine whether the improvements observed exceeded the minimal clinically important difference (MCID). In addition, the subgroup of people who did not have medication adjustments during their admission was analyzed separately to examine changes attributable to rehabilitation only. This study also identified the determinants that best predicted rehabilitation outcome. We hypothesized that people with PD would show statistically and clinically significant increases in functional abilities following participation in an inpatient multidisciplinary rehabilitation program administered by a rehabilitation team with expertise in movement disorders. We also hypothesized that disease duration and baseline functional status would be important predictors of rehabilitation outcome.
| Method |
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The FIM is a widely used measure of functional status developed specifically for people in inpatient acute care rehabilitation facilities. The FIM comprises 2 sections: motor (13 items) and cognitive (5 items). These items are rated with regard to the performance of ADL tasks on a 7-point ordinal scale from a score of 1 (complete dependence) to a score of 7 (independence), with a maximum possible total score of 126. The FIM has well-established reliability and validity as a generic instrument.6,7 It also has been shown to be responsive to change following intervention in people who have had a stroke11 but has not been studied in people with PD.
The TMW is a safe, simple, and useful measure of walking ability in people with PD. Each subject was instructed to cover as much distance as possible on foot in 2 minutes, being told, "Keep walking until I tell you to stop." A tester accompanied the subject, acting as a timekeeper and guarding as needed. Light and colleagues8 demonstrated that subjects with PD walk a significantly shorter distance (
=
88 m [294 ft]) than sex- and age-matched control subjects (
=
182 m [608 ft]).
The TUG is a quick test incorporating a transfer from a sitting position to a standing position, ambulation, and turning, which are frequently impaired in people with movement disorders.9 Interrater reliability has been demonstrated to be excellent (intraclass correlation coefficient=.99) using the TUG in people with PD.12 The subjects were seated in a chair with arms on the armrests and were instructed to stand, walk to a point 3 m (10 ft) away, turn around, walk back to the chair, and sit. One practice trial and one test trial were recorded. The subjects were allowed to use an assistive device if necessary. Normative values for older people range from 10 to 11 seconds without a cane and from 11.5 to 15.2 seconds with a cane.13
The FT was used to measure the impact of common symptoms of movement disorders (bradykinesia, dyskinesia, and tremor) on upper-extremity function. This measure was used to determine the impact of medication adjustments and rehabilitation on the upper extremities, particularly in subjects who were nonambulatory and unable to participate in other assessments. The FT has been shown to be reliable and valid.10,14 Two buttons attached to counters were mounted 30 cm apart. The subjects alternated tapping of the buttons with the left hand for 1 minute. The sum of the taps on both buttons was the result for the left hand. The test then was repeated with the right hand.
Intervention
The program used in this study was a comprehensive, specialized, inpatient multidisciplinary rehabilitation program. The aim of this program was to optimize the subjects medication regimens and functional abilities through a team approach. The movement disorders team consisted of a consulting neurologist with specialization in movement disorders, attending neurologists (at the inpatient rehabilitation facility) with specialization in neurorehabilitation, a movement disorders fellow, physical therapists, occupational therapists, speech-language pathologists, nurses, and case managers. Specific assessment and treatment approaches were developed for this movement disorders program, and staff received regular in-service education on the management of PD and movement disorders.
In addition to the outcome measures administered at admission and discharge, daily measures (TMW, TUG, and FT) were obtained at both the peak and the trough times of the medication cycle in order to capture fluctuations in a subject's status. Although the same therapists administered both the intervention and the outcome measures, all therapy staff involved in data collection participated in multiple training sessions in order to standardize the administration of the outcome measures. During weekly "walk rounds," the interdisciplinary team examined the data, observed subject function, and discussed overall subject status. On the basis of this information, decisions regarding appropriate medication changes were made. An additional weekly movement disorders team meeting was held to discuss subjects responses to the medication adjustments and to examine additional data points. Further changes were made as needed, and this process was continued until the subjects were discharged.
Throughout their length of stay, subjects participated in a combination of physical therapy, occupational therapy, and speech therapy for a minimum of 3 hours per day, 5 to 7 days per week. Therapy was provided on an individual basis and in a group format when appropriate. The components of the intervention were based on "best evidence" from the literature.15 These components included the use of external cueing to improve gait speed, step length, and cadence16–18; the application of cognitive movement strategies to improve bed mobility and transfers19,20; balance training21; exercises to improve joint mobility22,23 and strength (force-generating capacity)24; and voice treatment to improve volume and clarity of speech.25,26 An overview of the components of the intervention is shown in Table 2. These components were individualized to meet the needs of each study participant.
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=.007) was applied to all t tests. The effectiveness of the program was investigated for subjects who participated in rehabilitation in addition to having medication adjustments and for subjects who participated in rehabilitation but whose PD medications were not changed (rehabilitation only) during their inpatient admission. In addition, the clinical significance of the improvements observed was determined on the basis of the FIM total change scores. An FIM total change score of
22 has been shown to be associated with the MCID in people who have had a stroke.27 Therefore, in our study, a change from baseline to discharge of
22 was considered clinically meaningful, whereas a change of less than 22 was considered too small to be clinically meaningful.
To determine the relationship between baseline indices (independent variables) and treatment outcomes (dependent variables), we conducted a univariate analysis with Pearson correlation coefficients. The following factors served as predictor (independent) variables: age, disease duration, sex, education level, Hoehn and Yahr stage, prior level of function (physical assistance required or not required for daily bed mobility, transfer from sitting position to standing position, and gait prior to admission, according to subject or family report), PD symptoms on admission (rigidity, tremor, bradykinesia, postural instability, dyskinesia, and speech and cognitive impairments), and baseline status on each of the outcome measures. The dependent variable was FIM total change score (discharge status minus admission status). A stepwise regression analysis was conducted to identify which determinants identified as significant (P
.20) in the univariate analysis predicted rehabilitation outcome. The significance of each variable entered into the regression analysis was determined with a t test, the significance of R2 was determined with an F test, and the level of significance was set at .05. Colinearity diagnostics were applied for each variable entered into the regression analysis in order to control for unstable estimates of entered regression coefficients. All data analyses were performed with SPSS Professional Statistics (version 15.0) software (for Windows).*
| Results |
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Predictors of Rehabilitation Outcome
Significant correlations were found between the FIM total change score and prior level of function and between the FIM total change score and the presence of dyskinesia on admission. A lower prior level of function and the presence of dyskinesia were associated with less improvement in the FIM total score. Prior level of function accounted for 20% of the variance in the FIM total change score (Tab. 3). The presence of dyskinesia did not significantly improve model fit.
MCID in the FIM Total Score
All subjects made gains in the FIM total score, with a range of improvements from 4 to 75. Forty-eight subjects (71%) showed changes of
22 in the total FIM score, representing clinically important differences (Figure). Eighty-three percent of the subjects who did not require physical assistance prior to admission experienced clinically meaningful changes, whereas 41% of the subjects who required physical assistance prior to admission experienced clinically meaningful changes.
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| Discussion |
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Despite a growing body of literature demonstrating the benefits of exercise and rehabilitation for patients with PD, it is not part of standard practice in the United States to refer patients with PD for rehabilitation services. Historically, inpatient rehabilitation admission has not been considered for patients with a chronic, progressive disease such as PD unless there has been an acute event, such as a fracture or pneumonia. Despite the inclusion of PD as 1 of the 13 designated medical conditions for which intensive inpatient rehabilitation services have been determined to be medically necessary by the Centers for Medicare and Medicaid Services, patients experiencing declines in function related to their PD typically are not admitted to inpatient rehabilitation facilities.
The results of the present study demonstrated the benefits of inpatient rehabilitation for people who had primary, typical idiopathic PD and who were admitted as a result of frequent falling, a decline in functional status, or difficulty managing their current environment. As a result of this decline, they were at risk of losing their independence and requiring additional care at home or in an institutionalized setting. Despite the chronic, progressive nature of PD, most people made statistically significant and clinically meaningful gains from admission to discharge. This finding suggested the benefits of systematic pharmacological adjustments combined with intensive rehabilitation and 24-hour monitoring over a mean length of stay of 21 days. The outcomes of the present study, in which the participants predominantly had PD of Hoehn and Yahr stages III and IV, are consistent with the results of rehabilitation studies conducted on an outpatient basis in which the participants typically had PD of Hoehn and Yahr stages II and III, suggesting the benefits of rehabilitation in later stages of the disease.2,4
The improvements observed in the FIM motor, TMW, and TUG scores demonstrated changes at the functional level. Although people with PD are thought to have deficits in motor learning, they appear to be able to learn new, more effective strategies to help improve walking, rising from a chair, moving in bed, and performing ADL tasks. Daily practice of tasks in the present study allowed multiple repetitions for people to learn successful solutions. Smiley-Oyen and colleagues28 found that patients with PD were able to learn and retain 2 different movement sequences following extensive practice, with the majority of the changes occurring at between 1 and 2 weeks. In addition, a recent study29 suggested that patients with PD may benefit more from blocked practice than from random practice of tasks. This finding suggested that many repetitions of the same task, which occurred during the inpatient rehabilitation admission in the present study, may have been an important component of the intervention. In addition, research suggests that patients with PD are capable of activating compensatory cortical mechanisms to facilitate the execution of motor tasks in the presence of a dopamine deficit in the frontostriatal motor circuits.30 The external cueing strategies implemented in the present study to improve gait function may have served to enhance the recruitment of cortical areas while bypassing the poorly functioning basal ganglia.31 Studies22,24,32 also support the benefits of stretching, strengthening, and endurance training for people with PD. Although these components were included in the intervention in the present study, changes in these areas were not explicitly measured. Therefore, their contributions to the improvements made in function are unknown.
We considered whether the gains made in the present study were clinically significant in addition to being statistically significant. The change score of
22 was associated with an MCID in people after stroke.27 However, because this cutoff score was derived from people who had had a stroke, it may not be the most appropriate cutoff score for determining clinically meaningful change in people with PD. The data from the stroke study served as a starting point from which to interpret the clinical relevance of our findings, given the lack of research on determining MCIDs in outcome measures used for people with PD following pharmacological or rehabilitation interventions. Given that the gains of 71% of the subjects with PD exceeded the MCID of 22, it is plausible that the results for a substantial proportion of our sample of subjects would have continued to exceed the threshold even if the cutoff score were higher.
The ability to identify people with PD most likely to benefit from inpatient rehabilitation would help physicians and rehabilitation teams target patients more appropriately. The value of identifying important determinants of rehabilitation outcome has been demonstrated for other domains, such as stroke33 and chronic obstructive lung disease,34 but has not been investigated for PD. In the present study, prior level of function accounted for 20% of the variance in the FIM total change score. This result suggests the value of baseline status in predicting rehabilitation outcome. Additional studies with larger samples are needed to further investigate the predictors of rehabilitation outcome.
There are several limitations of the present study. The lack of a control group limited our ability to attribute the improvements observed specifically to rehabilitation or to the combination of pharmacological and rehabilitation interventions. Improvements attributable to other aspects of an inpatient hospital admission also cannot be ruled out. However, given the natural history of the disease, people with PD would not be expected to show improvements without intervention, particularly given the magnitude of the gains revealed in our results. In a recent randomized controlled trial investigating the efficacy of a rehabilitation program in an outpatient setting, we found that 38 subjects in a no-treatment control condition (medication management only) showed a mean improvement of only 0.9 m (3 ft) in TMW scores over a 6-week period (unpublished data). In contrast, there was a mean gain of 24 m (80 ft) over a mean of 20 days in the present study.
Another limitation of the present study was the lack of follow-up after discharge. Although the gains made were substantial, it is unknown whether the subjects were able to transfer these gains to their home environments. Even if the subjects were able to translate the gains made in the rehabilitation hospital to their home environments, it is unknown how long these gains were maintained. In addition, improvements in the present study were measured at the functional level. Changes in QOL and neurological impairments were not measured and should be considered in future studies. Measuring changes in the brain may also be important because studies investigating the impact of exercise in animal models of parkinsonism have suggested that forced exercise of the affected limb may reduce the vulnerability of dopamine neurons, in part because of an increase in the availability of glial cell line-derived neurotrophic factor.35,36 Further research is needed to investigate the potential neuroprotective effects of exercise on the progression of PD in humans during various stages of the disease process.
| Conclusion |
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| Footnotes |
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This study was approved by the Boston University Institutional Review Board and the Braintree Rehabilitation Hospital Medical Executive Committee.
This study was supported by the Dudley Allen Sargent Research Fund.
This study was presented, in part, as a poster at the American Congress of Rehabilitation Medicine–American Society of Neurorehabilitation conference; September 28–October 2, 2005; Chicago, Ill.
* SPSS Inc, 233 S Wacker Dr, Chicago, IL 60606. ![]()
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