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1. (WO2018042351) DEVICE AND SYSTEM STIMULATING FEELING, PERCEPTION AND MOTILITY
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DEVICE AND SYSTEM STIMULATING FEELING, PERCEPTION AND MOTILITY

The object of the present invention is a device and a system stimulating feeling, perception and motility for the rehabilitation of pareses and/or paralyses of upper limbs, in particular such as a unilateral paresis (hemiparesis), a unilateral paralysis (hemiplegia), a hemispatial neglect, after an intracerebral haemorrhage, cerebral infarction, craniocerebral injury, inflammatory and autoimmune diseases of the nervous system, metabolic diseases of the central nervous system (CNS), CNS oncological disorders, conditions after an oncological-neurosurgical intervention, in which a system comprising a device in the form of a glove detecting pressure and an armband or only an armband can be used, if feeling is retained in an upper limb.

In the case of sensory disturbance in an upper limb in the course of diseases of the central nervous system, as listed above, and peripheral neuropathies, like polyneuropathies (including diabetic, the Guillain-Barre syndrome), the above-mentioned system can be used, comprising a device in the form of a glove and an armband, in which the glove will detect pressure and send a message to the armband, which will inform the patient about the pressure.

The central nervous system serves various functions in human body. Its part responsible for the proper execution of voluntary movements and maintaining bodily posture is called a pyramidal system. This system is made of a central (Betz cells) and peripheral motor neuron and it has two tracts, which provide motor innervation of skeletal muscles. If the pyramidal system is damaged, a pyramidal syndrome, also called a central or upper motor neuron syndrome, will be observed in the ill person. Among symptoms characteristic for this syndrome are: weakened muscles, pareses, paralyses, located in a place depending on the damage (http://neuropsychologia.org/objawy-piramidowe). Currently, the symptoms of pyramidal syndromes, such as pareses and paralyses, are cured using a model of rehabilitation comprising kinesiotherapy, a therapy involving movement in the form of individual exercises with a physiotherapist and group exercises, physiotherapeutic procedures (magnetotherapy, electrotherapy, hydrotherapy, etc.) and neuropsychological procedures (therapy of attention, perception, speech). Sometimes physiotherapy proceeds according to certain methods. For example, neurodevelopmental methods like PNF and Bobath are popular in neurology. Sometimes, a therapy in an augmented reality is used (the patient manipulates their hand in a glove in a virtual environment).

However, usually this means one hour of therapy a day, possibly several hours a day. The patients are also given homework, which they do not perform due to an impaired motivation system. Therefore, there is still need for the development of a method and a system supporting rehabilitation by making the patients contact their paretic limb for all hours of a day except sleep.

Additionally, in the case of patients with sensory disturbance, there is a need to develop a device replacing feeling and signalling to the patient the pressure exerted on the upper limb.

Unexpectedly, the above-mentioned problems have been solved in the present invention thanks to the development of a device and a system for the rehabilitation of pareses and/or paralyses of upper limbs, a device in the form of a glove replacing feeling in the impaired limb and a system comprising the above-mentioned glove and an armband communicating with the patient and with the external environment.

Therefore, the object of the present invention is a device stimulating feeling, perception and motility for the rehabilitation of pareses and/or paralyses of upper limbs, which has the form of a glove and comprises pressure sensors on the top and inner sides, connected by electrical cables to a power supply, and a module for communication with other devices, such as Bluetooth.

Preferably, the pressure sensor is a contact or piezoelectric sensor.

Another object of the present invention is a system stimulating feeling, perception and motility for the rehabilitation of pareses and/or paralyses of upper limbs, characterised in that it comprises the above-mentioned device in the form of a glove and an armband/smartwatch for mounting on an impaired limb, comprising an electronic board, a processor/controller, a battery or an accumulator, a memory, an accelerometer, at least one element for communication with the user and a module for communication with other devices.

Preferably, the element for communication with the user is a speaker, a screen or an illuminated button, a vibrator.

Preferably, the armband with suitable software/the smartwatch stimulates feeling, perception and motility in predefined time intervals by a signal tone, a vibrating signal and a light signal.

Preferably, the other device for communication with the armband/smartwatch is a device in the form of a glove.

Preferably, the module for communication with other devices is a Bluetooth module.

Preferably, the system additionally comprises an application for a computer, a smartphone or another mobile device.

Preferably, the system additionally comprises a web service.

The invention also relates to a system for the rehabilitation of pareses and/or paralyses of upper limbs, characterised in that it comprises an armband/smartwatch for mounting on an impaired limb, comprising an electronic board, a processor/controller, a battery or an accumulator, a memory, an accelerometer, an element for communication with the user and a module for communication with other devices, and an application for a computer, smartphone or another mobile device.

Preferably, the system additionally comprises a web service.

The device according to the present invention in the form of a glove is intended to replace feeling in an impaired limb. The glove signalises the pressure exerted on the hand (squeezing the hand with one's body or an item), also, in the case of hemispatial neglect, meaning a perception disorder, it signalises the clenching of the hand as a result of spasticity. Thanks to the use of the glove, patients become aware of the appearance of stimuli which may damage the hand. The patients also obtain the ability to realise the clenching of fingers during locomotion, which usually takes place as an associated reaction. Due to this , they can willingly modulate muscle tension, and the control and awareness of the hand allows the reduction, or even elimination, of spasticity.

The invention will now be presented in more detail in a preferable embodiment, with reference to the attached drawings, in which:

Figs. 1 -4 present schematically the glove according to the invention;

Fig. 5 presents schematically the armband in a top and front view;

Fig. 6 presents a schematic diagram of the armband; and

Fig. 7 presents a schematic diagram of the glove.

An embodiment of the invention

The system for the rehabilitation of pareses and/or paralyses of upper limbs according to the present invention comprises:

- a glove with pressure sensors;

- an armband/smartwatch;

- an application for a computer, a smartphone or another mobile device;

- a web service.

Characteristics of the elements:

The glove is made of a breathable, thin material 3, provided with pressure sensors 1 (e.g. contact, piezoelectric) on the top and inner sides (Fig. 1 - 4). The pressure sensors 1 are connected via electrical cables 2 to a powering armband 4 provided with a power switch 5. The function of the glove is to record pressure on the dorsal side of the hand in a case when the patient presses their hand to something, sits on it, strikes it against some item. Therefore, the glove replaces the protective function of feeling and records the pressure on palm - the function of detecting the clenching of fingers, which is usually associated with neurological patients during motion. The glove communicates, e.g. by Bluetooth, with the armband/smartwatch or directly with a computer, smartphone or another mobile device, where the "tactile" data is being sent.

The armband/smartwatch presented in Fig. 5 comprises a switch 6, a speaker 7, hinges 8, a fastening 9, a body 10 and an illuminated button 1 1 , that is a button, e.g. with a LED, which flashes during activation and the patient must push "the flashing thing" in order to deactivate the alarm. The armband/smartwatch is also provided with an electronic board, a processor/controller, a battery, a vibrator, a screen, a flash memory, an accelerometer and a Bluetooth module. Every time interval preset by a therapist, the armband/smartwatch activates the alarm (e.g. every 10 minutes for 10 hours a day). The armband/smartwatch is mounted on the paretic hand and the alarm involves a one-time stimulation by a signal tone, vibration and screen flashing. The patient must use their other hand to deactivate the alarm by touching the screen. During the time between the activation of the alarm and its deactivation , the software measures the reaction time and acceleration range by the accelerometer in 3 planes of

movement. The data is stored in the memory of the device, or in the case of an active connection with a computer, a smartphone or another mobile device, it is immediately transmitted to a server.

Additionally, in the case of the detection of outside pressure or the clenching of the hand by the glove, the armband/smartwatch transmits return information to the patient, e.g. by a voice message (e.g. open your hand, mind your hand) and vibration.

The function of the application is to receive the data transmitted by the glove and the armband/smartwatch, transmit this data via the Internet to a server, connect to a web service with a user profile, graphically and digitally present the collected data, as well as to analyse the risk of spasticity and to suggest recommendations (contact a neurologist, do not clench your hand, consider a botulinum toxin injection, etc.). Additionally, in the case of neglecting to switch the alarm off, the application will contact a caretaker, stating the patient's location in the case of the ill who are at risk of another stroke or epileptic seizure.

The system according to invention may also comprise a web service, where registered users may watch the progress of the rehabilitation of the upper limb, receive graphical reports of changes in terms of limb movement, receive proposals of exercises, training programmes and suggestions regarding the rehabilitation procedure.

The functionality of the system according to the present invention in terms of physiotherapy

The application activates the device on the wrist of the paretic hand every preset time interval (10-60 minutes) for at least 10-12 hours a day. The patient's function is to deactivate the alarm (vibration, flashing, signal tone) by touching the screen.

The assumed timeframes for the given phases of recovering from the pyramidal syndrome may differ depending on the nosological unit (an intracerebral haemorrhage, a cerebral infarction, a craniocerebral injury, an inflammatory disease of the nervous system, a metabolic disease, an oncological disorder, condition after an oncological-neurosurgical intervention), the age of the ill person, as well as the general state of health and intensity of the conducted physiotherapy and the coexistence and complexity of perceptual syndromes.


The patient's functional The patient's reaction

Neurophysiological and functional effect status to stimulation

torso towards the paralysed limb, stimulating exertion of the paralysed body part, activating the extensors of the lower limb and torso, the learning of anti-gravity work, activation of muscle tension in the paralysed part of the torso, including abdominal muscles and chest muscles, constructing postural stability and improving ventilation, along with a positive impact on intestinal peristalsis.

Upper limb paresis, the If possible, lifting and As above, plus the activation of adductors, inner beginning of tension in adduction of the upper rotators and flexors of the paretic upper limb, distal parts (fingers, limb - moving it closer to meaning the muscles which become spastic the wrist), minimal the midline of the body to most frequently. Active movement and learning the movement of proximal deactivate the device. cortical control of these muscles is a condition of the parts (shoulder- Followed by intentional normalisation of muscle tension and it does not scapula) loosening and lowering allow the development of spasticity. The build-up of of the limb. muscle tension in proximal parts-avoidance/therapy

(from several weeks to

of shoulder subluxation. A painful shoulder is about a dozen weeks)

associated with the head of the humerus sliding out of the socket and with stretching the ligaments, a joint capsule, peripheral muscles and nerves, which often causes pain so strong that it precludes the patient from undertaking any rehabilitation. This subluxation takes place due to the gravitational "pulling" of the limb from the joint because of its weight, and without the protection of muscle tension. Periodic activation by the application eliminates subluxation.

Weaker paresis of the Flexion and adduction of As above, plus obtaining an active movement of upper limb, the ability the paretic upper limb. flexion and extension in the elbow joint. Stimulating to perform an active Upon deactivating the the device by a distal key point - wrist - restores the flexion of the elbow device, straightening the natural timing of movement. A stimulus on the joint limb in the elbow joint. periphery of the limb causes the beginning of the movement from the most distal part of the upper

(from about a dozen

limb, restoring the physiological sequence of weeks to several

movement (activating the segments of the body). months)

Regression of upper Flexion and return As above, plus restoring active movements inside limb paresis, the ability (pronation) of the all large joints of the paretic upper limb, the

The patient's functional The patient's reaction

Neurophysiological and functional effect status to stimulation

to pronate the forearm forearm of the paretic capability of multifunctionality, multitasking, because upper limb (the gesture the device activates every preset time interval,

(from several months

of "looking at the when the patient performs different actions and is in to about a dozen

watch"), returning the different positions.

months)

limb into the vicinity of

the hip.

The phase of The gesture of "looking Supplementation of cognitive physiotherapy and commencing cognitive at the watch" rehabilitation. Implementation of the assumptions of rehabilitation the Bobath therapy involving the stimulation of paretic body parts for the whole part of the day

(after about a dozen

besides sleep. The body will always discriminate months)

against the paretic side of the body. The device will force continuous activity of the limb and equalise the level of activity. An improvement of interhemispheric communication by the interaction of both upper limbs and the head/sight.