Multiple Sclerosis Clinical Trial
Official title:
Robot-based Assessment and Therapy in the Treatment of Upper Limb Impairment in Multiple Sclerosis: a Multi-center, Randomised Controlled Trial
Robot-assisted therapy has proven effective in the neuromotor rehabilitation of eg stroke
survivors. Robots can be programmed to interact with patients by guiding their movements, by
monitoring their performance and by quantifying the type and degree of their impairment.
A distinctive element of multiple sclerosis is the involvement of a variety of functional
systems, in a way that is highly subject-specific. This requires a personalization of
treatment, and continuous adaptation to changes in condition. This points to a need for
integrating patient assessment, definition of rehabilitation protocols, their administration
and the assessment of their outcome.
The goal of this study is to assess, in persons with MS, the efficacy of a type of
robot-assisted training that was specifically designed to counteract incoordination and
muscle weakness (typical of MS), tailored to individual type and degree of impairment, when
compared to simple movement training.
In recent years, the potential of robots in the treatment of persons with motor disabilities
has raised considerable interest. These devices may interact with patients by assisting or
perturbing their movements, may monitor their performance and even quantify their
impairment. Clinical trials involving stroke survivors clearly demonstrated that
robot-therapy results in improved motor control. More recently, robot-therapy has been
applied to other pathologies. A pilot study carried out by the proponents suggested that
Multiple Sclerosis (MS) subjects with predominantly cerebellar symptoms may indeed benefit
from robot-therapy. MS subjects with different symptoms may benefit from robot therapy as
well, but the variety of symptoms and degrees of impairment that is typical of MS suggests
that robots may fully show their potential if therapy is tailored on the individual
subjects.
In this study, the proponents aim at extending the results of the above mentioned pilot
study to MS subjects with a wider variety of impairments. Based on previous studies on robot
therapy with MS subjects and stroke survivors, the proponents will develop and test a robot
training exercise that is specifically designed to deal with incoordination and/or muscle
weakness. In a randomised controlled trial, the proponents will then assess the possible
contribution of this form of robot-therapy to the rehabilitation of MS subjects.
A population of clinically definite MS subjects with different degrees of upper limb
impairment was randomised into 2 groups: (i) Haptic training and (ii) Sensorimotor training.
Haptic training was based on a robot-assisted exercise protocol specifically designed to
treat cerebellar and motor symptoms in persons with MS by counteracting, respectively,
incoordination and muscle weakness. The exercise is based on a motor task - interaction with
a virtual mass-spring system under the effect of a resistive load - that requires
sophisticated coordination skills. Task difficulty (the time constant of the mass-spring
system) and the magnitude of the resistive load (stiffness magnitude of the resistive
spring) were automatically adjusted to the individual subjects' upper limb impairment.
In Sensorimotor training, the task is exactly the same, but the robot generates no forces.
Hand and target position are displayed on the computer screen. This group allowed
quantifying the specific contribution of robot assistance to sensorimotor recovery (if any).
Both groups performed 8-10 therapy sessions (1 hour/each, 2-3 times per week). Treatment
outcome was assessed in terms of the Nine-Hole Peg Test (9HPT) and the ARAT scores.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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