The aim of this study is to evaluate the effects of an assisted rehabilitation treatment through a robotic exoskeleton device on the functional recovery in a group of patients with hemiparesis from lesion of the first motor neuron (post-stroke), compared with a group of patients subjected to a conventional rehabilitation treatment. The patients enrolled in the study are chronic stroke injured with right hemiparesis of moderate to severe degree, by the system injury pyramid, never undergoing rehabilitation treatment with robots.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
RH-LEXOS is a robotic exoskeleton device to support the rehabilitation of stroke patients. This system is conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. Passive, assisted and active mobilization of upper arm is provided through the use of the exoskeleton robotic device within high intensive, repetitive, task-oriented exercises and an objective and reliable mean for monitoring patients' progress.
University Hospital of Pisa
Pisa, Italy
Change in Fugl-Meyer Assessment (FMA( Score
The null hypothesis tested in this study was the change in motor function domain of the upper extremity portion of the Fugl-Meyer assessment in the Robotic Group (Robotic Treatment) would be the same as the one obtained by the Control Group (Conventional Treatment). The FMA outcome is further divided and analyzed in terms of sub-items. In particular, the motor FMA score is divided into proximal (shoulder and elbow movement, 36 points) and distal (hand and wrist movement, 24 points) sub-items.
Time frame: baseline and 6 weeks
Functional scale: Bimanual Activity Test (BAT)
The BAT is a functional scale designed to quantify the contribution of patient's affected upper limb to execute 25 common Activities of Daily Living such as Loosen and tighten the cap of a bottle , or unscrew a bolt. The elapsed time for accomplishing each task is measured and the therapist also give a score (ranging from 1 to 4) about the quality of each movement. The BAT data is analyzed also in terms of sub-items, divided into pinch-tasks and power-tasks collecting those items requiring fine and gross manipulation motor skills respectively.
Time frame: baseline and 6 weeks
Modified Ashworth (MA) scale
The MA scale (Bohannon and Smith, 1987) is used to evaluate spasticity of the upper limb and to assess abnormal muscle tone at the shoulder and elbow. The MA scale is a 6-point scale: scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement. MA scores were averaged across the two joints and across testing directions (flexion, extension) to estimate abnormal muscle tone in the upper extremity (Zackowski, Dromerick et al., 2004)
Time frame: baseline and 6 weeks
Robotic kinesiological assessment of movement: Execution Time
This measure is evaluated only in the group of patients performing robotic training, at the end of each session through the analysis of their performance during the execution of an evaluation exercise without robotic assistance.The patients are instructed to reach different targets positioned in front of them and placed around a vertical circumference at 12 equally spaced locations. The robotic measure is extracted for each outgoing (from the center to the target) movement. The execution time is measured as the elapsed time (measure in seconds) for accomplishing each movement, measured from the time of grasping of the virtual object at the start position to the release time at the target position.
Time frame: At end of each session, during 6 weeks of enrollment in treatment
Robotic kinesiological assessment of movement: Smoothness index
This measure is evaluated only in the group of patients performing robotic training, at the end of each session through the analysis of their performance during the execution of an evaluation exercise without robotic assistance.The patients are instructed to reach different targets positioned in front of them and placed around a vertical circumference at 12 equally spaced locations. The robotic measure is extracted for each outgoing (from the center to the target) movement. The smoothness index is computed in the same interval period by counting the number of peaks in the velocity profile of movement, namely the Number of Movements Units (NMU) (Fasoli S, Krebs J Neurosci 2002)
Time frame: At end of each session, during 6 weeks of enrollment in treatment
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