John W. Engstrom, Stephen L. Hauser
There is a lack of compelling evidence that physical rehabilitation is effective in the treatment of multiple sclerosis (MS). Solari and colleagues (1999) report the results of a randomized, single-blind, controlled trial of inpatient physical rehabilitation program in MS. Inclusion criteria were clinically definite or laboratory-supported MS, age 18-65 years, and an expanded disability status scale (EDSS) score between 3 and 6.5. Exclusion criteria consisted of at least one exacerbation within the preceding 3 months; cognitive impairment likely to interfere with the study; a history of cardiac, respiratory, orthopedic, psychiatric, or other medical conditions limiting study participation; pregnancy; use of immunosuppressants, interferon, copolymer, 4-aminopyridine, or experimental drugs in the preceding 6 months; or rehabilitation within 3 months prior to study entry. Patients were not allowed to use interferon, copolymer, cyclophosphamide, 4-aminopyridine, or intravenous steroids during the study. Patients were randomized to physical rehabilitation or control treatment (a home exercise program). Physical examinations were scheduled at baseline and weeks 3, 9, and 15 after study entry. Evaluation scales were Kurtzke's EDSS, Hauser's Ambulation Index, the Functional Independence Measure (FIM), and the Hamilton rating scale for depression. Health-related quality of life was assessed by a 36-item short form health survey questionnaire (SF-36). The inpatient rehabilitation program was 3 weeks long and consisted of 45-min exercise periods twice per day. The specific therapeutic approach differed according to the degree of impairment and disability. Goals for patients with an EDSS score of <4.5 were postural control, facilitation of normal gait, increasing range of motion, and maximizing muscle power and endurance. For patients with an EDSS score >4.5, use of appropriate aids to maximize mobility (such as orthoses) and compensatory strategies were added to the rehabilitation program. One primary outcome measure was the effect of the program on disability as measured by the motor component of the FIM; the latter consists of self-care, transfer, and locomotion scales. Another primary outcome measure was a change in neurologic impairment as assessed by the EDSS. A secondary endpoint was quality of life as assessed by the SF-36.
Of the 304 patients screened over a 2-year period, 50 were enrolled in the study. Of these, 27 were assigned to active and 23 to control treatment. Common exclusions were EDSS scores out of range, current enrollment in physical rehabilitation, ongoing immunosuppressant use, and recent MS exacerbation(s). The change in EDSS scores clustered around zero at the end of rehabilitation in both groups. On the other hand, an improvement in the FIM occurred in 48 percent of intervention patients, compared with 9 percent of controls (p = .004). This effect persisted at 9 weeks. At 15 weeks, there continued to be significant improvements in self-care and locomotion among the intervention group. There was a statistically significant difference between study group and control patients for general health and mental health subscale scores.
It is noted that while impairment was not affected by the rehabilitation program, there was a significant improvement in the FIM motor domain; the degree of improvement in disability was clinically useful. The SF-36 profile showed significant improvement in the mental composite score at 3 and 9 weeks. The authors conclude that physical rehabilitation in patients with MS has a positive effect on disability.
The accompanying editorial by Aisen (1999) reviews the challenges facing investigators who hope to define the objective value of neurorehabilitation on MS. The editorial cites existing studies demonstrating that fitness and affect are improved in MS patients enrolled in aerobic training programs. An outpatient control group undergoing intensive rehabilitation would have helped in the Solari study to determine the extent to which hospitalization is a necessary component of intensive treatment.
1.Aisen ML: Justifying neurorehabilitation: A few steps forward. Neurology
52:8, 1999 [PMID 9921839]
2.Solari A et al: Physical rehabilitation has a positive effect on disability in multiple sclerosis patients. Neurology 52:57, 1999 [PMID 9921849]