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StrokeMORENCT05416619

Effects of Hand MOtor Rehabilitation Using a sEMG-biofeedback

A study testing REMO® in people with Stroke and Stroke, Ischemic, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stroke is the first cause of disability worldwide. The motor impairment of the hand is one of the most common sequelae in patients after stroke. Indeed, approximately 60% of patients with diagnosis of stroke suffers from hand sensorimotor impairment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Stroke, Ischemic, Stroke Hemorrhagic
What is being tested?
REMO®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
14 Aug 2017to 27 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Single ischemic or haemorrhagic stroke
  • able to control at least 1 movement with REMO (i.e. able to cross 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)

Who cannot join

  • Untreated epilepsy;
  • Major depressive disorder;
  • Fractures;
  • Traumatic Brain Injury;
  • Severe Ideomotor Apraxia;
  • Severe Neglect;
  • Severe impairment of verbal comprehension.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS San Camillo Hospital

    Venice-Lido, Venice, 30126

Other trials in Italy

About this study

Official title: Effects of Hand MOtor Rehabilitation Using a sEMG-biofeedback, After Stroke: a Longitudinal Pilot Study

Stroke is the first cause of disability worldwide. The motor impairment of the hand is one of the most common sequelae in patients after stroke. Indeed, approximately 60% of patients with diagnosis of stroke suffers from hand sensorimotor impairment. In the last years, new approaches in neurorehabilitation field has been permitted to enhance hand motor recovery. Wearable devices permit to apply sensors to the patient's body for monitoring the kinematic and dynamic characteristics of patient's motion. Moreover, wearable sensors combined with electrodes detecting muscle activation (i.e. surface electromyography - sEMG) permit to provide biofeedback to the patient to improve motor recovery.

Read the detailed description

The aim of the study is to investigate the effect of using REMO® (Morecognition srl, Turin, Italy) device in hand motor rehabilitation.

The device REMO® is 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 sEMG-biofeedback exercises in stroke rehabilitation training. The device is developed by clinicians of IRCCS San Camillo Hospital and Morecognition Srl.

A total of 20 patients with first diagnosis of stroke and with no other neurological diagnosis or severe cognitive impairment has been enrolled. The patients are tested with REMO® and if they are able to control at least one movements, they are enrolled in the longitudinal pilot study. The treatment consists in 15 sessions, 1hour/day, for 5 days/week, for 3 weeks. The patients are clinically evaluated before and after the REMO® treatment to define clinical effect of the sEMG-biofeedback training.

Being tested
REMO®
Keywords
Neurological Rehabilitation, Hand Recovery, Electromyography
Medical subject headings
Stroke, Ischemic Stroke, Hemorrhagic Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REMO®Device

    The patients receive daily 1 hour of conventional therapy and 1 hour of treatment of REMO®, that is a wearable composed by 8 bipolar electrodes able to detect the surface electromyography of the forearm muscles. REMO® allows the control of a computer interface using the surface electromyography to execute sEMG-biofeedback exercises for hand rehabilitation. The movements required for hand rehabilitation are the following: thumb abduction, pinch, finger flexion, finger extension, wrist flexion, wrist extension, forearm pronation, forearm supination, radial wrist deviation and ulnar wrist deviation. The treatment consists in 15 sessions, 1hour/day, for 5 days/week, for 3 weeks. The patients are clinically evaluated before and after the REMO® treatment.

Study groups in NCT05416619
Study groupRoleWhat they receive
sEMG-biofeedback GroupExperimentalReceive 1 hour of sEMG-biofeedback hand training provided by wearable REMO® and 1 hour of daily conventional rehabilitation therapy.
Receives: Device: REMO®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Upper Extremity

    Fugl-Meyer Upper Extremity is a stroke-specific scale which assesses the upper limb motor functioning in patients with post-stroke hemiplegia. There are 3 values: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to upper limb hemiplegia. The maximum value is 66 points, which corresponds to normal motor performance.

    Measured: Change from baseline, at 3 weeks (15 sessions).

Secondary outcomes (8)

  1. Fugl-Meyer - sensation

    Sensation of the hemiparetic side is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to completely impaired sensory functioning. The maximum value is 24 points, which corresponds to normal sensory functioning.

    Measured: Change from baseline, at 3 weeks (15 sessions).

  2. Fugl-Meyer - pain and Range of Motion

    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 impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to maximum level of pain and restriction. The maximum value is 48 points, which corresponds to no pain and normal range of motion.

    Measured: Change from baseline, at 3 weeks (15 sessions).

  3. Box and Blocks Test

    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.

    Measured: Change from baseline, at 3 weeks (15 sessions).

  4. Reaching Performance Scale

    Reaching Performance Scale 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. The minimum value is 0 points, which corresponds to incapacity of any ability of reaching an object. The maximum value is 36 points, which corresponds to the preservation of the ability of reaching an object.

    Measured: Change from baseline, at 3 weeks (15 sessions).

  5. Modified Ashworth Scale

    Spasticity is measured using the Modified Ashworth Scale of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total score = 20 points). The therapist evaluates the spasticity of each muscles. There are 5 values: 0 (no increase in muscle tone), 1 (slight increase in muscle tone), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone), 4 (affected part rigid in flexion or extension).

    Measured: Change from baseline, at 3 weeks (15 sessions).

  6. Nine Hole Pegboard Test

    Nine Hole Pegboard Test 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.

    Measured: Change from baseline, at 3 weeks (15 sessions).

  7. Functional Independence Measure

    Functional Independence Measure scale is an 18-item scale that assesses the degree of independence in carrying out activities of daily living. There are 7 values: 1 (Total Assistance or not Testable), 2 (Maximal Assistance), 3 (Moderate Assistance), 4 (Minimal Assistance), 5 (Supervision), 6 (Modified Independence), 7 (Complete Independence). The minimum values is 18 points, which corresponds to the lower level of independence in activities of daily living. The maximum value is 126 points, which corresponds to the maximum level of independence in activities of daily living.

    Measured: Change from baseline, at 3 weeks (15 sessions).

  8. Number of movements controlled by REMO® device

    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 sEMG recording during baseline (i.e. rest position).

    Measured: Change from baseline, at 3 weeks (15 sessions).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2022
  2. Study start14 Aug 2017
  3. Primary completion11 Feb 2019
  4. Study completion27 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Intervention is provided by a wearable device for hand rehabilitation. The device is composed by 8 bipolar electrodes that are able to detect muscle activation to control a computer interface to execute sEMG-biofeedback training for hand motor recovery.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05416619
Sponsor's protocol ID
2016.29.1
Acronym
MORE
Status last verified
Jun 2022
First submitted
31 May 2022
Last updated
13 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Celadon N, Dosen S, Binder I, Ariano P, Farina D. Proportional estimation of finger movements from high-density surface electromyography. J Neuroeng Rehabil. 2016 Aug 4;13(1):73. doi: 10.1186/s12984-016-0172-3.

    PubMed 27488270

  • Paleari M, Di Girolamo M, Celadon N, Favetto A, Ariano P. On optimal electrode configuration to estimate hand movements from forearm surface electromyography. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:6086-9. doi: 10.1109/EMBC.2015.7319780.

    PubMed 26737680

  • Di Girolamo M, Celadon N, Appendino S, Turolla A. and Ariano P. EMG-based biofeedback system for motor rehabilitation: A pilot study,. IEEE Biomedical Circuits and Systems Conference (BioCAS). 2017; pp. 1-4, doi: 10.1109/BIOCAS.2017.8325086.

  • Parker J, Powell L, Mawson S. Effectiveness of Upper Limb Wearable Technology for Improving Activity and Participation in Adult Stroke Survivors: Systematic Review. J Med Internet Res. 2020 Jan 8;22(1):e15981. doi: 10.2196/15981.

    PubMed 31913131

  • Maceira-Elvira P, Popa T, Schmid AC, Hummel FC. Wearable technology in stroke rehabilitation: towards improved diagnosis and treatment of upper-limb motor impairment. J Neuroeng Rehabil. 2019 Nov 19;16(1):142. doi: 10.1186/s12984-019-0612-y.

    PubMed 31744553

Questions about this trial

What is this clinical trial studying?

A study testing REMO® in people with Stroke and Stroke, Ischemic, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Upper Extremity (time frame: Change from baseline, at 3 weeks (15 sessions).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05416619, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.

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