Multiple Sclerosis Clinical Trial
Official title:
Standardized Comprehensive Two-month Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis: a Randomized-controlled Trial
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS)
and the most common cause of non-traumatic disability in young adults in western countries.
Despite increasing therapeutic options to ameliorate the disease course, most patients suffer
from persistent neurological deficits over time.
Disability in MS has a negative impact on patients life's impairing activities of daily
living (ADL) and quality of life (QoL) and leading to loss of work and the need providing
care. This results in tremendous socioeconomic burden.
Disease-modifying treatments prevent disability progression in variable extent. However no
drugs are available ameliorate persistent disability in MS. Therefore, exercise training as
well as physical and occupational therapies are important in the symptomatic treatment of MS.
Physical and occupational therapy is usually performed close to patients home by therapist
with different professional background in a non-standardized way.
The investigators therefore aim to develop a standardized comprehensive ambulatory
neurorehabilitation program, integrating task oriented circuit training for MS patients to
improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital
settings.
Background
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS)
and the most common cause of non-traumatic disability in young adults in western countries.
The incidence of MS is low in childhood and increases after the age of 18, reaching a peak
between 20 and 40 years (mean age of 30 years) with women being affected approximately 2-5
years earlier than men. In Switzerland the incidence is thought to be 4:100.000 with
approximately 12.500 affected patients.
Despite increasing therapeutic options to ameliorate the disease course, most patients suffer
from persistent neurological deficits over time.
Neurologic symptoms can be manifold and are highly variable amongst patients. They include
loss of vision, sensorimotor defects, impaired manual dexterity, ataxia, apraxia, gait
disturbances, bladder- and bowl problems, fatigue, cognitive dysfunctions and others, which
alone, or in combination, lead to disability in MS patients. Disability in MS has a negative
impact on patients life's impairing activities of daily living (ADL) and quality of life
(QoL) and leading to loss of work and the need providing care. This results in tremendous
socioeconomic burden.
Disease-modifying treatments prevent disability progression in variable extent. However no
drugs are available ameliorate persistent disability in MS. Therefore, exercise training as
well as physical and occupational therapies are important in the symptomatic treatment of MS.
Intensive task oriented circuit training has been shown to be effective in stroke improving
gait, and several ADL. Some pilot randomized controlled trials in MS demonstrated exercise
training being able to improve muscular strength, aerobic capacity and ambulatory performance
as well as fatigue, balance and gait. Furthermore, specific therapies improve manual
dexterity, coordination and mobilization in MS patients as well. Although, so far no
randomized trial has been done to prove the effectiveness of task oriented circuit training
in MS.
Physical and occupational therapy is usually performed close to patients home by therapist
with different professional background in a non-standardized way.
The investigators therefore aim to develop a standardized comprehensive ambulatory
neurorehabilitation program, integrating task oriented circuit training for MS patients to
improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital
settings.
Objective
To evaluate the impact of a standardized comprehensive ambulatory neurorehabilitation program
on disability in patients with multiple sclerosis measured by performance based test of the
upper and lower extremities and by patient recorded outcome measures regarding functioning of
the upper and lower extremities, activities of daily living and quality of life.
The investigators hypothesize that this training program will improve disability, activities
of daily living and quality of live in MS patients.
Methods
Prospective double center, randomized, cross-over study. Consecutive MS patients that
complain about disability that affects ADL and/or QoL will be recruited to participate in a
comprehensive ambulatory neurorehabilitation program. Afterwards baseline measurements will
be performed and patients will be randomized 1:1 into the early treatment group or the
delayed treatment group in groups of four using sealed envelopes. The early treatment group
starts the neurorehabilitation program whereas in the delayed treatment group, patients will
be put on a waiting list for two months. After two months, outcome measurements will be
collected. Patients of the early treatment group stop the neurorehabilitation program and
patients of the delayed treatment group start the neurorehabilitation program for two months
("cross-over design"). Two months after ending the program, each group will be retested.
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