Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis (SM-FES)

May 22, 2023 updated by: Intento SA

Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis: A Multi-Centre, Single-Blind, Randomized Parallel Study

The study aims at demonstrating the efficacy of self-modulated functional electrical stimulation (SM-FES) in promoting upper-limb (UL) motor recovery in chronic stroke patients with severe and severe-moderate paralysis.

The effect of such experimental therapy will be compared to dose-matched, goal-oriented standard care (SC).

SM-FES consists of intensive, goal-oriented, repetitive functional exercises assisted by electrical stimulation. The patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand.

The duration of the intervention is 90 min per day, 5 days per week, for 2 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After the informed consent process, each centre will screen potential participants according to the inclusion and exclusion criteria.

Each recruited participant will be randomly assigned to one group:

  • experimental group - patients will receive self-modulated functional electrical stimulation SM-FES;
  • control group - patients will receive standard care SC.

This first main phase of the study includes 10 days intervention delivered to the two groups and assessments pre-intervention, post-intervention and after 3 months (follow-up).

After the follow-up, participants initially recruited in the control group will be able to enter a secondary exploratory phase and receive further 10 days of treatment with SM-FES.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital
      • Genève, Switzerland, 1205
        • Hôpitaux Universitaires de Genève
      • Tschugg, Switzerland, 3233
        • Klinik Bethesda Tschugg
    • Vaud
      • Lausanne, Vaud, Switzerland, 1005
        • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of one, first-ever ischemic stroke verified by brain imaging (i.e. computed tomography or magnetic resonance imaging);
  • chronic impairment after stroke, i.e. time since event ≥ 6months;
  • severe and severe-moderate upper limb impairment, i.e. FMA-UE score ≤ 34;
  • 18 ≤ age < 80;
  • ability to give consent, understand the device use and follow instructions.

Exclusion Criteria:

  • an unstable recovery stage, measured as a difference between screening and baseline examinations of more than 3 points in the motor part of the FMA-UE scale;
  • contraindications and risk factors to neuromuscular electrical stimulation;
  • severe hemi-spatial neglect or anosognosia involving the affected arm, as determined by the Bells tests (> 6 errors);
  • severe impairment of proprioception, as evaluated from the blinded detection and discrimination of imposed passive movements (≥ 20° extension or flexion) of the finger proximal joint (>3 errors out of 6 mobilisations);
  • severe impairment of tactile sensing in the hand, as assessed by Semmes-Weinstein monofilament test (no detection of the 5.88 size evaluator);
  • excessive spasticity, as indicated by a score > 2 in any of the items of the REsistance to PASsive movement (REPAS) arm subtest;
  • recurrent, moderate to high upper limb pain limiting delivery of rehabilitation dose, i.e. pain at rest and in correspondence of a passive range of motion lower than 50%;
  • botulinum toxin injection into affected upper extremity during 3 months before the study or during the study;
  • history of physical / medical conditions interfering with study procedure, for example shoulder subluxation, upper extremity injury that limits the function of the hand or arm, skin lesion/rash/open wound on the affected upper extremity, or similar;
  • history of neurological condition interfering with study procedure, e.g. Parkinson's disease, progressive brain diseases like dementia and tumours;
  • use of antipsychotic medications;
  • enrolled in the past six months in another study involving drugs, biologics, upper limb experimental therapy, or similar.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Self modulated functional electrical stimulation (SM-FES)
Patients will receive self-modulated functional electrical stimulation SM-FES
Device: Self-modulated functional electrical stimulation (SM-FES)

The patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand. A device called the Intento PRO will be used to deliver the experimental treatment.

Duration: 90 min per day, 5 days per week, for 2 weeks.
Active Comparator: Standard care (SC)
Patients will receive standard care, dose matched to the experimental group therapy
Other: Standard Care

The patient performs intensive, goal-oriented, repetitive functional exercises.

Duration: 90 min per day, 5 days per week, for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the motor part of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale, calculated from baseline to post-intervention (2 weeks)
Time Frame: From baseline to post-intervention (2 weeks)
The FMA-UE measures the upper limb motor impairment. FMA-UE consists of 33 items. Each item is scored on a 3-point ordinal scale (0, 1, and 2) with 0 generally corresponding to no function, 1 to partial function, and 2 to perfect function. The items are summed to the final maximal score of 66 (no impairment).The FMA may also be divided into shoulder/elbow and wrist/hand sub-scores consisting of 18 and 15 tasks, with a maximum score of 36 and 30, respectively. Higher scores indicate less impairment.
From baseline to post-intervention (2 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale at 3 months (T3) compared to baseline (T0)
Time Frame: At 3 months (T3) compared to baseline (T0)
The FMA-UE measures the upper limb motor impairment. FMA-UE consists of 33 items. Each item is scored on a 3-point ordinal scale (0, 1, and 2) with 0 generally corresponding to no function, 1 to partial function, and 2 to perfect function. The items are summed to the final maximal score of 66 (no impairment). The FMA may also be divided into shoulder/elbow and wrist/hand sub-scores consisting of 18 and 15 tasks, with a maximum score of 36 and 30, respectively. Higher scores indicate less impairment.
At 3 months (T3) compared to baseline (T0)
Number and proportion of patients with change of at least 5 FMA-UE points from baseline (T0) to 2 weeks (T2) post-intervention and 3 months (T3) follow-up
Time Frame: From baseline (T0) to 2 weeks (T2) post-intervention and 3 months (T3) follow-up
Fugl-Meyer Assessment of the Upper Extremity (FMA-UE).
From baseline (T0) to 2 weeks (T2) post-intervention and 3 months (T3) follow-up
Change of upper limb function measured by the Action Research Arm test (ARAT) from baseline to post-intervention (2 weeks) and to 3 months follow-up
Time Frame: From baseline to post-intervention (2 weeks) and to 3 months follow-up
The ARAT measures of the upper limb function. It contains 19 items grouped into 4 subscales: grasp, grip, pinch and gross motor. In the first 3 subscales, the scale assessed the ability to grasp, move, and release objects of differing size, weight, and shapes. The last subtest evaluates 3 gross movements (place hand behind head, place hand on top of head, and move hand to mouth). Each item is graded on an ordinal scale from 0-3, all of which are summed to yield a score of 0 to 57. Higher scores indicate less impairment.
From baseline to post-intervention (2 weeks) and to 3 months follow-up
Change of perceived upper limb function measured by the Motor Activity Log (MAL) from baseline to post-intervention (2 weeks) and to 3 months follow-up
Time Frame: From baseline to post-intervention (2 weeks) and to 3 months follow-up

The MAL is a measure of perceived upper limb disability in activities of daily living.

The MAL-14 includes 14 items, scored on an 11-point amount of use (AOU) scale (range 0-5) to rate how much the arm is used and an 11-point quality of movement (QOM) scale (range 0-5) to rate how well patients are using their affected upper extremity.
From baseline to post-intervention (2 weeks) and to 3 months follow-up
Change of hand and arm spasticity measured by the REsistance to PASsive movement (REPAS) from baseline to post-intervention (2 weeks) and to 3 months follow-up
Time Frame: From baseline to post-intervention (2 weeks) and to 3 months follow-up
The REPAS consists of several items across different defined joints, each of which are rated according to the Modified Ashworth Scale (MAS) (0 = no increase in muscle tone to 4 = limb rigid in flexion or extension), and includes assessments of the shoulder, elbow, forearm, wrist, finger. A higher score indicates more severe impairment, with a maximum upper limb score of 64.
From baseline to post-intervention (2 weeks) and to 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intento SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Geneva
University Hospital Inselspital, Berne
Centre Hospitalier Universitaire Vaudois
University of Bern
Innosuisse - Swiss Innovation Agency
KLINIK BETHESDA Tschugg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-02402
  • 10000465 (Other Identifier: Swissmedic)
  • CIV-CH-19-02-027064 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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