StrokeREMONCT05815368
Efficacy of REMO Training for Hand Motor Recovery After Stroke
A study testing REMO and Task-Oriented Training in people with Stroke and Stroke, Ischemic, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial summary
Upper limb motor impairment is one of the most common sequelae after stroke. Indeed, the recovery of upper limb sensory-motor functions remains one of the most important goals in stroke rehabilitation. In the last years, new approaches in neurorehabilitation field has been investigated to enhance motor recovery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic
- What is being tested?
- REMO and Task-Oriented Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 4 Oct 2022to 13 Jan 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Single ischemic or haemorrhagic stroke
- Fugl-Meyer Upper Extremity score: minimum 10/66 points
Who cannot join
- 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, 1 recruiting
- Recruiting
IRCCS San Camillo Hospital
Venice-Lido, Venice, 30126
Giorgia Pregnolato, +0412207 ext. 214, giorgia.pregnolato@hsancamillo.it
About this study
Official title: REcovery of Hand Motor Function in Stroke Rehabilitation: Efficacy of a Task-Oriented Protocol Provided by a sEMG-biofeedback Wearable Device (REMO)
Upper limb motor impairment is one of the most common sequelae after stroke. Indeed, the recovery of upper limb sensory-motor functions remains one of the most important goals in stroke rehabilitation.
In the last years, new approaches in neurorehabilitation field has been investigated to enhance motor recovery. The use of wearable devices combined with surface electromyography (i.e. sEMG) electrodes allows to detect patients muscle activation during motor performance. Moreover, sEMG is used to provide to the patients the biofeedback about their muscle activity during exercises execution to enhance motor control and motor recovery. The aim of the study is to define the efficacy of using REMO® (Morecognition srl, Turin,Italy) for hand motor recovery after stroke.
A randomised-controlled trial will be conducted compared to a task-oriented training, in hand motor rehabilitation after stroke. 28 patients with diagnosis of first stroke event will be enrolled in this study. After randomization process, participants will be allocated in Experimental Group (REMO training) or in Control Group (task-oriented training). The participants will be assessed before and after the treatment and sEMG will be collected during 12 hand movements. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). Finally, the sEMG of the same 12 hand movements will be collected from 15 healthy subjects to compare muscle activation with a normal reference model.
Read the detailed description
Stroke is the first cause of permanent disability worldwide. The last American Heart Association (AHA) statistical update showed that in the next years the rate of people affected by stroke is going to increase, most in young people. Indeed, last projections showed that by 2030 an additional 3.4 million adults will have had a stroke, a 20.5% increase in prevalence from 2021. Moreover, upper limb motor impairment is one of the most common sequelae after stroke. The impairment of upper limb motor functions compromises the level of autonomy of the patients in activity of daily living. Thus, the recovery of upper limb sensory-motor functions remains one of the most important goals in stroke rehabilitation.
In the last years, new approaches in neurorehabilitation field have been investigated to enhance motor recovery. The use of wearable devices consist of the application of sensors to the patient's body parts. The advantage of wearable sensor is to collect data from patients' movements to assess motor functions with high level of accuracy. Moreover, wearable device combined with surface electromyography (i.e. sEMG) electrodes allows to detect patients muscle activation during motor performance. sEMG is used also to provide to the patients the biofeedback about their muscle activity during exercises execution to enhance motor control and motor recovery. Surface electromyographic biofeedback showed good results in neurological conditions to improve motor control and hand motor recovery.
The investigators developed a wearable device (REMO®) that collected sEMG from forearm muscles during hand movements. In recent works, the investigators defined the feasibility and security of using REMO in a rehabilitation setting. Moreover, the investigators defined the clinical features of stroke patients able to control the device to execute up to 10 hand movements in order to control a rehabilitation computer interface. The aim of this study is to define the efficacy of using REMO® (Morecognition srl, Turin,Italy) for hand motor recovery after stroke compared to a specific protocol of hand motor rehabilitation (i.e., task-oriented training).
A randomised-controlled trial will be conducted compared to a task-oriented training, in hand motor rehabilitation after stroke. 28 patients with diagnosis of first stroke event, and with no other neurological diagnosis or severe cognitive impairment, will be enrolled in this study. After randomization process, participants will be allocated in Experimental Group (REMO training) or in Control Group (task-oriented training). The participants will be assessed before and after the treatment to define the clinical effects of the hand training. Moreover, the investigators will collect sEMG data using REMO device during 12 hand movements required to the patients before and after the training. The treatment consists of 15 sessions, (1hour/day, for 5 days/week, for 3 weeks). Finally, the sEMG of the same 12 hand movements will be collected from 15 healthy subjects to compare patients' muscle activation with a normal reference model.
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Stroke Sequelae
- Being tested
- REMO, Task-Oriented Training
- Keywords
- Neurological Rehabilitation, Surface Electromyography, Upper Extremity, Motor Impairment, Biofeedback, Motor Recovery
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMODevice
REMO training will consist of sEMG-biofeedback exercises provided by REMO device. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks.
Task-Oriented TrainingOther
Task-Oriented training will consist of task-specific functional exercises. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| REMO training | Experimental | REMO training will consist of sEMG-biofeedback exercises provided by REMO device. Receives: Device: REMO |
| Task-Oriented training | Active comparator | Task-Oriented training will consist of task-specific functional exercises Receives: Other: Task-Oriented Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity - hand
Fugl-Meyer Upper Extremity - hand section is a specific section of Fugl-Meyer Upper Extremity assessment that assesses the wrist and hand motor function in patients with post-stroke hemiplegia. There are 3 values:0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0. The maximum value is 24 points, which corresponds to normal hand motor function.
Measured: Change from Baseline Fugl-Meyer Upper Extremity (hand items) at 3 weeks
Secondary outcomes (13)
Fugl-Meyer Upper Extremity
Fugl-Meyer Upper Extremity is a stroke-specific scale which assesses the upper limb motor functions in patients with post-stroke hemiplegia. There are 3 values:0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0.
Measured: Change from Baseline Fugl-Meyer Upper Extremity at 3 weeks
Fugl-Meyer Assessment - 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 Fugl-Meyer Assessment (sensation) at 3 weeks
Fugl-Meyer Assessment - 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 48points, which corresponds to no pain and normal range of motion.
Measured: Change from Baseline Fugl-Meyer Assessment (pain and Range of Motion) at 3 weeks
Box and Blocks Test
The patient has to carry as much cubes as possible, one by one, from a box to another one in one minute. The test is performed with both hands.
Measured: Change from Baseline Box and Blocks Test at 3 weeks
Reaching Performance Scale
Reaching Performance Scale assesses the ability of subjects to reach an object (acone). 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 assessor valuates the quality of reaching instead of the grip strength. The minimum value is0 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 to reach an object.
Measured: Change from Baseline Reaching Performance Scale at 3 weeks
Modified Ashworth Scale - flexor carpi muscles
Level of spasticity of flexor carpi muscles is measured using the Modified Ashworth Scale. 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 Modified Ashworth Scale (flexor carpi muscles) at 3 weeks
Nine Hole Pegboard Test
Nine Hole Pegboard Test measures the dexterity of the hand. Patient should insert9 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 Nine Hole Pegboard Test at 3 weeks
Functional Independence Measure
Functional Independence Measure scale is an 18-item scale that assesses the level 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 Functional Independence Measure at 3 weeks
Action Research Arm Test
Action Research Arm Test (ARAT) assesses upper limb functioning using observational methods. It is a 19 item measure divided into 4 sub-items (grasp, grip, pinch, gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally; 2) Completes test, but takes abnormally long or has great difficulty; 1) Performs test partially; 0) Can perform no part of test. The maximum score on the ARAT is 57 points (possible range 0 to57).
Measured: Change from Baseline Action Research Arm Test at 3 weeks
Cylindric Grasp Force
The Cylindric Grasp Force is assessed with Dynamometer (CITEC Dynamometer, N).
Measured: Change from Baseline Cylindric Grasp Force at 3 weeks
Abilhand questionnaire
The ABILHAND questionnaire assesses bimanual ability as an interview-based test focused on the patient's perceived difficulty. Bimanual ability is defined as the capacity to manage daily activities that require the use of both hands, whatever the strategies involved. Three levels of response scale for each item, rated as 'Impossible=0, Difficult=1, Easy=2, Not applicable=missing data.'.
Measured: Change from Baseline Abilhand questionnaire at 3 weeks
Abilhand questionnaire
The ABILHAND questionnaire assesses bimanual ability as an interview-based test focused on the patient's perceived difficulty. Bimanual ability is defined as the capacity to manage daily activities that require the use of both hands, whatever the strategies involved. Three levels of response scale for each item, rated as 'Impossible=0, Difficult=1, Easy=2, Not applicable=missing data.'.
Measured: Change from Baseline Abilhand questionnaire at 7 weeks
System Usability Scale
The System Usability Scale (SUS) provides a reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start4 Oct 2022
- Primary completion13 Jan 2025 (estimated)
- Study completion13 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized-Controlled Trial (RCT)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgia Pregnolato, IRCCS San Camillo, Venezia, Italy
- Investigators
- Giorgia Pregnolato, Principal investigator, IRCCS San Camillo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815368
- Sponsor's protocol ID
- 2021.13
- Acronym
- REMO
- Status last verified
- Feb 2024
- First submitted
- 16 Mar 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
PubMed 35363499Parker 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 31913131Di 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.
D. Rimini et al.,
Pregnolato G, Rimini D, Baldan F, Maistrello L, Salvalaggio S, Celadon N, Ariano P, Pirri CF, Turolla A. Clinical Features to Predict the Use of a sEMG Wearable Device (REMO(R)) for Hand Motor Training of Stroke Patients: A Cross-Sectional Cohort Study. Int J Environ Res Public Health. 2023 Mar 14;20(6):5082. doi: 10.3390/ijerph20065082.
PubMed 36981992
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REcovery of Hand Motor Function in Stroke Rehabilitation: Efficacy of a Task-Oriented Protocol Provided by a sEMG-biofeedback Wearable Device (REMO)
- ClinicalTrials.gov ID
- NCT05815368
- Acronym / sponsor ID
- REMO / 2021.13
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Stroke Sequelae
- Keywords
- Neurological Rehabilitation, Surface Electromyography, Upper Extremity, Motor Impairment, Biofeedback, Motor Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 13 Jan 2025 (estimated)
- Study completion
- 13 Jan 2025 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Upper limb motor impairment is one of the most common sequelae after stroke. Indeed, the recovery of upper limb sensory-motor functions remains one of the most important goals in stroke rehabilitation.
In the last years, new approaches in neurorehabilitation field has been investigated to enhance motor recovery. The use of wearable devices combined with surface electromyography (i.e. sEMG) electrodes allows to detect patients muscle activation during motor performance. Moreover, sEMG is used to provide to the patients the biofeedback about their muscle activity during exercises execution to enhance motor control and motor recovery. The aim of the study is to define the efficacy of using REMO® (Morecognition srl, Turin,Italy) for hand motor recovery after stroke.
A randomised-controlled trial will be conducted compared to a task-oriented training, in hand motor rehabilitation after stroke. 28 patients with diagnosis of first stroke event will be enrolled in this study. After randomization process, participants will be allocated in Experimental Group (REMO training) or in Control Group (task-oriented training). The participants will be assessed before and after the treatment and sEMG will be collected during 12 hand movements. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). Finally, the sEMG of the same 12 hand movements will be collected from 15 healthy subjects to compare muscle activation with a normal reference model.
Detailed description
Stroke is the first cause of permanent disability worldwide. The last American Heart Association (AHA) statistical update showed that in the next years the rate of people affected by stroke is going to increase, most in young people. Indeed, last projections showed that by 2030 an additional 3.4 million adults will have had a stroke, a 20.5% increase in prevalence from 2021. Moreover, upper limb motor impairment is one of the most common sequelae after stroke. The impairment of upper limb motor functions compromises the level of autonomy of the patients in activity of daily living. Thus, the recovery of upper limb sensory-motor functions remains one of the most important goals in stroke rehabilitation.
In the last years, new approaches in neurorehabilitation field have been investigated to enhance motor recovery. The use of wearable devices consist of the application of sensors to the patient's body parts. The advantage of wearable sensor is to collect data from patients' movements to assess motor functions with high level of accuracy. Moreover, wearable device combined with surface electromyography (i.e. sEMG) electrodes allows to detect patients muscle activation during motor performance. sEMG is used also to provide to the patients the biofeedback about their muscle activity during exercises execution to enhance motor control and motor recovery. Surface electromyographic biofeedback showed good results in neurological conditions to improve motor control and hand motor recovery.
The investigators developed a wearable device (REMO®) that collected sEMG from forearm muscles during hand movements. In recent works, the investigators defined the feasibility and security of using REMO in a rehabilitation setting. Moreover, the investigators defined the clinical features of stroke patients able to control the device to execute up to 10 hand movements in order to control a rehabilitation computer interface. The aim of this study is to define the efficacy of using REMO® (Morecognition srl, Turin,Italy) for hand motor recovery after stroke compared to a specific protocol of hand motor rehabilitation (i.e., task-oriented training).
A randomised-controlled trial will be conducted compared to a task-oriented training, in hand motor rehabilitation after stroke. 28 patients with diagnosis of first stroke event, and with no other neurological diagnosis or severe cognitive impairment, will be enrolled in this study. After randomization process, participants will be allocated in Experimental Group (REMO training) or in Control Group (task-oriented training). The participants will be assessed before and after the treatment to define the clinical effects of the hand training. Moreover, the investigators will collect sEMG data using REMO device during 12 hand movements required to the patients before and after the training. The treatment consists of 15 sessions, (1hour/day, for 5 days/week, for 3 weeks). Finally, the sEMG of the same 12 hand movements will be collected from 15 healthy subjects to compare patients' muscle activation with a normal reference model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized-Controlled Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| REMO training | Experimental | Device: REMOREMO training will consist of sEMG-biofeedback exercises provided by REMO device. |
| Task-Oriented training | Active comparator | Other: Task-Oriented TrainingTask-Oriented training will consist of task-specific functional exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single ischemic or haemorrhagic stroke
- Fugl-Meyer Upper Extremity score: minimum 10/66 points
Key exclusion criteria (6 listed)
- Major depressive disorder;
- Fractures;
- Traumatic Brain Injury;
- Severe Ideomotor Apraxia;
- Severe Neglect;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMOREMO training will consist of sEMG-biofeedback exercises provided by REMO device. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks. | Device | REMO training |
| Task-Oriented TrainingTask-Oriented training will consist of task-specific functional exercises. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks. | Other | Task-Oriented training |
Primary outcome
Fugl-Meyer Upper Extremity - hand
Time frame: Change from Baseline Fugl-Meyer Upper Extremity (hand items) at 3 weeks
Fugl-Meyer Upper Extremity - hand section is a specific section of Fugl-Meyer Upper Extremity assessment that assesses the wrist and hand motor function in patients with post-stroke hemiplegia. There are 3 values:0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0. The maximum value is 24 points, which corresponds to normal hand motor function.
13 secondary outcomes
Fugl-Meyer Upper Extremity
Time frame: Change from Baseline Fugl-Meyer Upper Extremity at 3 weeks
Fugl-Meyer Assessment - sensation
Time frame: Change from Baseline Fugl-Meyer Assessment (sensation) at 3 weeks
Fugl-Meyer Assessment - pain and Range of Motion
Time frame: Change from Baseline Fugl-Meyer Assessment (pain and Range of Motion) at 3 weeks
Box and Blocks Test
Time frame: Change from Baseline Box and Blocks Test at 3 weeks
Reaching Performance Scale
Time frame: Change from Baseline Reaching Performance Scale at 3 weeks
Modified Ashworth Scale - flexor carpi muscles
Time frame: Change from Baseline Modified Ashworth Scale (flexor carpi muscles) at 3 weeks
Nine Hole Pegboard Test
Time frame: Change from Baseline Nine Hole Pegboard Test at 3 weeks
Functional Independence Measure
Time frame: Change from Baseline Functional Independence Measure at 3 weeks
Action Research Arm Test
Time frame: Change from Baseline Action Research Arm Test at 3 weeks
Cylindric Grasp Force
Time frame: Change from Baseline Cylindric Grasp Force at 3 weeks
Abilhand questionnaire
Time frame: Change from Baseline Abilhand questionnaire at 3 weeks
Abilhand questionnaire
Time frame: Change from Baseline Abilhand questionnaire at 7 weeks
System Usability Scale
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 35363499Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
- Background: PubMed 31913131Parker 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.
- BackgroundDi 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.
- BackgroundD. Rimini et al.,
- Background: PubMed 36981992Pregnolato G, Rimini D, Baldan F, Maistrello L, Salvalaggio S, Celadon N, Ariano P, Pirri CF, Turolla A. Clinical Features to Predict the Use of a sEMG Wearable Device (REMO(R)) for Hand Motor Training of Stroke Patients: A Cross-Sectional Cohort Study. Int J Environ Res Public Health. 2023 Mar 14;20(6):5082. doi: 10.3390/ijerph20065082.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgia Pregnolato principal investigator
IRCCS San Camillo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMO and Task-Oriented Training 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 6 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: status not confirmed, as of the sponsor's last update on 15 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giorgia Pregnolato (+0412207 ext. 214, giorgia.pregnolato@hsancamillo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity - hand (time frame: Change from Baseline Fugl-Meyer Upper Extremity (hand items) at 3 weeks). 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 NCT05815368, 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 15 Feb 2024.