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NCT Number: NCT04889586

Hand MOtor Rehabilitation Using a EMG-biofeedback: a Cross-sectional Study

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Hemiplegia Hemorrhagic Stroke Ischemic Stroke Nervous System Diseases Neurologic Manifestations Paralysis Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Hemorrhagic Stroke, Ischemic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Camillo Hospital

Venice-Lido, Venice, 30126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMG-biofeedback armband (REMO)

Device

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.

Primary outcomes

  1. Fugl-Meyer Upper Extremity (FMA-UE)

    Time frame: 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 outcomes

  1. Fugl-Meyer - sensation

    Time frame: 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)

  2. Fugl-Meyer - pain and Range of Motion

    Time frame: 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)

  3. Box and Blocks Test (BBT)

    Time frame: 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.

  4. Reaching Performance Scale (RPS)

    Time frame: 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).

  5. Modified Ashworth Scale (MAS)

    Time frame: 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).

  6. Nine Hole Pegboard Test (NHPT)

    Time frame: 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.

  7. Functional Independence Measure scale (FIM)

    Time frame: 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).

  8. Number of movements controlled by EMG-biofeedback device

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

IRCCS San Camillo, Venezia, Italy

Other

Registry information

Official study title

Hand Motor Recovery Using a EMG-biofeedback in Stroke Rehabilitation: a Cross-sectional Study

Acronym: MORE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 17, 2021
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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