Acute Stroke Clinical Trial
Official title:
Study of the Effectiveness of an Interactive Robot for the Rehabilitation of the Upper Limb in Acute Stroke Patients by Evaluating the 3 Fields of the ICF: a Prospective, Randomized, Controlled, Simple Blind Study
Stroke is the principal cause of permanent disability within the investigators population.
This incapacity justifies an intensive and prolonged multidisciplinary rehabilitation, which
can be optimized by robotics.
The investigators team has developed a robot designed to rehabilitate the upper limb. This
robot allows the patient to perform active, passive, or assisted exercises. The system is
also able to assess movement quality and to provide a feedback to the patient and the
therapist via a graphical interface. This therapy is designed to improve functional recovery
of patients, and then their quality of life.
Few quality studies have evaluated the efficacy of robotic assisted therapy in patients at
the acute stage of rehabilitation (< 3 months post stroke) when most improvements are
observed.
Thus, the aim of this study was to objectify the effectiveness of robotic-assisted
rehabilitation in the acute stage after stroke by evaluating the 3 fields of the ICF
(International Classification of Functioning, Disability and Health) and performing a
prospective multicenter randomized controlled single blind trial. In this study, 60 stroke
patients will be recruited and randomized into two groups. All patients will receive a
similar classical rehabilitation as a basis. Patients of the control and experimental groups
will receive a supplement of classical rehabilitation and robotic-assisted therapy,
respectively.
INTRODUCTION
The cerebral vascular accident affects two people per thousand each year (Duncan et al.
2005). This injury is the leading cause of permanent disability in our population. The brain
damage is expressed by different neurological impairments and functional disabilities. These
disabilities justify intensive and sustained multidisciplinary rehabilitation to reduce
neurological impairments, to improve the activities and participation of patients, and,
ultimately, their quality of life (Duncan et al., 2005).
Recently appeared in rehabilitation to stimulate maximum brain plasticity robotic devices
meet the actual recommendations existing in stroke's rehabilitation (Langhorne et al., 2011).
Indeed, the robots allow the execution of a large number of movements whose quality is
controlled. A visual interface gives the patient a feedback of its movements, and offers
exercises oriented functional tasks that have meaning for him and the possibly dive into a
virtual reality. All these elements justify the clinical development of robots to assist the
therapists (Pignolo et al. 2009).
The therapeutic efficacy of these robots for the rehabilitation of the upper limb was
evaluated especially in chronic stroke patients (> 6 months after stroke) (Mehrholz et al.,
2012). Unfortunately, few quality studies was conducted in these patients at the acute stage
of rehabilitation, during which the potential of brain plasticity is the most important and
the largest functional progress are observed (Stinear et al. 2012). In addition, few studies
have evaluated the effect of these therapies robotic on the three fields of the ICF (Mehrholz
et al., 2012). Many studies focus on impairments (e.g. muscle strength) without assessing the
functional ability of the patient in activities of daily living.
OBJECTIVES
To perform a multicenter, single blind, randomized, controlled trial to assess the efficacy
of of robotic-assisted therapy in acute stroke patients by evaluating the three fields of the
ICF.
METHODS
Patients will be included in the Cliniques Universitaires Saint-Luc (Brussels, Belgique) and
the center of William Lennox (Ottignies, Belgique). The patients will be randomised into two
groups (control and experimental), using a stratified randomization method to ensure the
equivalence of the two groups for motor neurological impairments (score of the Fugl-Meyer).
This randomization will be organized independently in each centre participating in the study.
The study of statistical power shows that 27 patients per group are necessary. This study of
power has taken into account a statistical power desired to 99%, a minimum detectable change
to 0.09 and a standard deviation of 0.08 on the upper limb kinematics of the patient
(Gilliaux et al. 2014). In estimating a risk of out drop to 10%, the investigators plan to
recruit 60 patients.
In each centre, in the acute phase, the patients receive daily a multidisciplinary
rehabilitation (physiotherapy, occupational therapy, speech therapy,...) more or less
intensive (60 to 300 min). In the experimental group, one of these daily therapies will be
devoted to the rehabilitation robot, 4 times a week for 9 weeks. The control group will
benefit from conventional treatments. As such, the duration of support will be similar
between the two groups. All treatments will be administered by therapists specialized in
neurological rehabilitation.
Patients will be evaluated three times in the study: before the start of treatments, at the
end of treatments, and 6 months after the stroke event. All assessments will be carried out
by a therapist which will be not informed the group that the patient is assigned
(single-blind).
PERSPECTIVES
From this study, the investigators hope to demonstrate the efficacy of robotic-assisted
therapy in acute stroke patients by evaluating the three fields of the ICF. These results
could prove that this tool can be a significant complement for the stroke rehabilitation.
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