Upper limb disabilities are among the most debilitating issues after a cerebral stroke. One promising approach in motor rehabilitation is the use of functional electrical stimulation (FES). This technique can be integrated into daily therapy to follow an adaptive approach, exploiting the residual capacities of patients. FES can help to stimulate the affected muscles, improve coordination and strengthen the weakened muscles, thus supporting the rehabilitation process.
18 years or older
Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks
Medical Research Council score for at least one upper limb muscle greater than 0 and less than 5 (excluding extremes).
Signed informed consent
Score at the Mini Mental State Examination (adjusted for age and schooling) < 24
Clinical evidence in the case of visual disturbance, ideomotor apraxia, behavioral disorders, neglect, sensory, visual and auditory disturbances of severe degree or otherwise that prevent use of the device
Major head trauma
Cardio-respiratory or internal clinical instability
Parallel
EMG-based FES rehabilitation
DeviceEach subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises while using the FitFES device.
Traditional rehabilitation
Other interventionEach subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises.
Action Research Arm Test (ARAT)
The ARAT test assesses upper limb functioning through the execution of 19 tasks, divided in 4 sub-tests (grasp, grip, pinch, and gross arm movement). Each movement is scored on a 4-point ordinal scale (0=no movement, 1=movement partially performed, 2=movement completed but takes abnormally long; 3=movement performed normally). Total possible score is 57 points, with higher scores associated to best motor functioning.
Fugl-Meyer Upper Extremity scale (FM-UE)
The Fugl-Meyer Assessment of Motor Recovery after Stroke is one of the most widely used measures of motor impairment in post-stroke hemiplegic patients, covering 5 domains (Motor fu ENnction, sensory function, balance, joint range of motion, joint pain). The assessment of upper extremity motion is performed using the Upper Extremity assessment (FM-UE), including items scored on a 3-point ordinal scale (0: cannot perform, 1: performs partially; 2: performs fully) with a total maximum score: 66 points (higher scores, best clinical profile).
Box and Block test (BBT)
The Box and Block Test (BBT) measures unilateral gross manual dexterity. The BBT goal is to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The score is determined by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. Higher scores on the test indicate better gross manual dexterity
EuroQol 5-Dimension 5-level (EQ-5D-5L) Questionnaire
EQ-5D-5L is a standardized instrument for use as a measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, the EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status. It measures the 5 dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension is scored on a Likert scale of 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Surface Electromyography (EMGs)
Surface Electromyography (EMGs) is a non-invasive tool able to assess muscular electrical activity during the execution of active movements using electrodes applied on the skin surface. Muscular contraction amplitude will be recorded from 24 sensors placed on upper limbs (12 sensors/limb), during the execution of motor acts. Then, the difference between patient's and observed model's temporal dynamic of muscular contraction will be chosen as EMG outcome.
Body Kinematics
Kinematics of the upper limb and trunk will be recorded using a 9-camera optoelectronic system during 3D motor acts. The system will measure the 3D coordinates of spherical markers attached to body landmarks to compute trunk, shoulder, elbow and wrist angles. Data processing will provide measures of deviations from physiological movement.
Treatment Safety
Data related to the safety of the device will be collected: 1. Number of adverse events 2. Number of drop-out related to patient intolerance to the device
Cost-effectiveness ratio
The costs of the two rehabilitation paths (with and without device), related to direct costs (maintenance device, consumables) and indirect costs will be collected (training of therapists on the device, costs related to the patient using the device). Procedures to be performed in a single treatment session will also be evaluated, in terms of time needed for preparation and dressing, and of trained personnel required during a session. An estimate of the working cycles that the device can perform in a year will also be considered.
Age data
Age of participants will be collected
Gender data
Gender of participants will be collected
Scholarity data
Scholarity of participants will be collected
Click on the lead sponsor to view all of their trials.
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Istituto Italiano di Tecnologia
Collaborator
Ospedale Policlinico San Martino
Collaborator
