Hemiparesis, Hemiplegia, Stroke, Stroke Hemorrhagic, Stroke, Ischemic
Conditions
Keywords
Neurological Rehabilitation, Upper Extremity, Electromyography, Hand Gesture
Brief summary
Recovery of upper limb and hand gestures is fundamental for autonomy restoration after stroke. Innovative technologies are a valid support for the delivery of rehabilitation treatments. Embedding surface electromyographic (sEMG) into wearable devices, allows the customisation of rehabilitation exercises, based on the clinical profile of each patient.
Detailed description
The aims of this study are to determine safety and feasibility of a prototype EMG-control wearable device (REMO) and to individualise clinical features of stroke survivors able to control the EMG armband targeted to hand rehabilitation. The device REMO consists in an armband composed by 8 bipolar electrodes able to record and process the electromyography of forearm muscles. The patterns of muscle activations are classified and used to perform EMG-biofeedback exercises in stroke rehabilitation training. The device is developed by clinicians of IRCCS San Camillo Hospital and spin-off Morecognition Srl. A total of 100 stroke patients patients has been recruited. They are clinically assessed and then tested on the ability to control the sEMG wearable device. The test is composed of 10 hand and fingers gestures to be performed with the paretic hand. Baseline and activation sEMG signals are recorded and compared for each movement. Three conditions representing absent, partial or full control of the device are defined and logistic multivarialbes regression models are used to identify clinical features describing the group each patient belongs to. Clinical cut-off for each strata is identified by odds ratio.
Interventions
DEVICEEMG-biofeedback armband (REMO)
After clinical evaluation, the subjects execute an instrumental test. By wearing EMG-biofeedback device (REMO), the subjects have to perform 10 different hand gestures: thumb abduction, pinch, finger flexion, finger extension, wrist flexion, wrist extension, forearm pronation, forearm supination, radial wrist deviation and ulnar wrist deviation. The muscle activations (EMG signals) during the execution of each movements, are recorded for 3 seconds.
Sponsors
IRCCS San Camillo, Venezia, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Each subject is assessed with a clinical protocol and an instrumental test, consists in executing 10 hand gestures by wearing a EMG-biofeedback armband
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Single ischemic or haemorrhagic stroke; * Score lower than 100 out of a total of 126 at the Functional Independence Measure (FIM) scale
Exclusion criteria
* Untreated epilepsy; * Major depressive disorder; * Fractures; * Traumatic Brain Injurj; * Severe Ideomotor Apraxia; * Severe Neglect; * Severe impairment of verbal comprehension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Upper Extremity (FMA-UE) | within 1 week from enrolment. | Motor function of the upper limb is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairiment), 2 (preserved function) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer - sensation | within 1 week from enrolment. | Sensation of the hemiparetic side is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairiment), 2 (preserved function) |
| Fugl-Meyer - pain and Range of Motion | within 1 week from enrolment. | Pain and Range of Motion of the hemiparetic upper limb is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairiment), 2 (preserved function) |
| Box and Blocks Test (BBT) | within 1 week from enrolment. | The patient has to carry as much cubes as possible, one by one, from a container to another one in one minute. The test is performed with both hands. |
| Number of movements controlled by EMG-biofeedback device | within 1 week from enrolment. | The patient is able to control a movement with the device if he crosses the pre-defined empirical threshold (10%) of the ratio between the maximum voluntary contraction (MVC) of the movement and the EMG recording during baseline (i.e. rest position). |
| Modified Ashworth Scale (MAS) | within 1 week from enrolment. | Spasticity is measured using the MAS of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total score = 20 points). |
| Nine Hole Pegboard Test (NHPT) | within 1 week from enrolment. | NHPT measures the dexterity of the hand. Patient should insert 9 pins in the board. There are 9 pins. The number of pins inserted in 50 sec are registered or if the patient inserted 9 pins, then the time is registered. |
| Functional Independence Measure scale (FIM) | within 1 week from enrolment. | FIM is an 18-item scale that assesses the degree of autonomy in carrying out activities of daily living (total score = 126 points). |
| Reaching Performance Scale (RPS) | within 1 week from enrolment. | RPS assesses the ability of subjects to reach an object (a cone). The cone is placed at both 4-cm (close) and 30-cm (far) distance from the subject. The subject is asked to reach and grab the cone if possible. The observer evaluates the quality of reaching instead of the grip strength (Total score = 36 points). |
Countries
Italy
Outcome results
None listed