Stroke RehabilitationSM-FESNCT04014270

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

A study testing Self-modulated functional electrical stimulation (SM-FES) in people with Stroke Rehabilitation, run by Intento SA at 4 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke Rehabilitation
What is being tested?: Self-modulated functional electrical stimulation (SM-FES)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 4 sitesSwitzerland
Study dates: 8 Nov 2019to 22 May 2023
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 12Show fewer

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.

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

Inselspital
Bern, 3010
Hôpitaux Universitaires de Genève
Geneva, 1205
Centre hospitalier universitaire vaudois
Lausanne, Canton of Vaud, 1005
Klinik Bethesda Tschugg
Tschugg, 3233

Other trials in Switzerland

About this study

Official title: 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 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.

Read the 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.

Conditions: Stroke Rehabilitation
Being tested: Self-modulated functional electrical stimulation (SM-FES), Standard Care
Keywords: Electrical stimulation, Upper limb rehabilitation, Hemiplegia
Medical subject headings: Hemiplegia

What participants receive

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

Self-modulated functional electrical stimulation (SM-FES)Device
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.
Standard CareOther
The patient performs intensive, goal-oriented, repetitive functional exercises.
Duration: 90 min per day, 5 days per week, for 2 weeks.

Study groups in NCT04014270
Study group	Role	What they receive
Self modulated functional electrical stimulation (SM-FES)	Experimental	Patients will receive self-modulated functional electrical stimulation SM-FES Receives: Device: Self-modulated functional electrical stimulation (SM-FES)
Standard care (SC)	Active comparator	Patients will receive standard care, dose matched to the experimental group therapy Receives: Other: Standard Care

What is being measured

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

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)
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.
Measured: From baseline to post-intervention (2 weeks)

Secondary outcomes (5)

Change of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale 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.
Measured: 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
Fugl-Meyer Assessment of the Upper Extremity (FMA-UE).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From baseline to post-intervention (2 weeks) and to 3 months follow-up

Timeline

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

8 Nov 201922 May 2023

First posted10 Jul 2019
Study start8 Nov 2019
Primary completion26 Oct 2021
Study completion22 May 2023

Why it stopped: * Challenges experienced in recruitment. * Shifts in the sponsor's priorities and organizational structure resulting from its integration into a larger corporate group.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stroke RehabilitationStudies 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04014270
Sponsor's protocol ID: 2018-02402
Other IDs: 10000465, CIV-CH-19-02-027064, 2018
Acronym: SM-FES
Status last verified: May 2023
First submitted: 8 Jul 2019
Last updated: 24 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
Recruiting
Telerehabilitation In The Home After Stroke
Stroke
Enrolling by invitation
AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke
Spinal Cord Injuries (SCI)
Active, not recruitingObservational study
Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
Stroke, Acute, Gait, Hemiplegic

All Stroke Rehabilitation trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis: A Multi-Centre, Single-Blind, Randomized Parallel Study
ClinicalTrials.gov ID: NCT04014270
Acronym / sponsor ID: SM-FES / 2018-02402
Conditions: Stroke Rehabilitation
Keywords: Electrical stimulation, Upper limb rehabilitation, Hemiplegia
Study type: Interventional
Recruitment status: TerminatedReason stopped: * Challenges experienced in recruitment. * Shifts in the sponsor's priorities and organizational structure resulting from its integration into a larger corporate group.
Enrolment: 29 participants (actual)
Lead sponsor: Intento SAIndustry (pharma, biotech, devices)
Collaborators: Centre Hospitalier Universitaire Vaudois, University Hospital, Geneva, KLINIK BETHESDA Tschugg, Insel Gruppe AG, University Hospital Bern, University of Bern, Innosuisse - Swiss Innovation Agency
Study start: 8 Nov 2019 (actual)
Primary completion: 26 Oct 2021 (actual)
Study completion: 22 May 2023 (actual)
First posted: 10 Jul 2019 (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.

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

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Self modulated functional electrical stimulation (SM-FES)	Experimental	Device: Self-modulated functional electrical stimulation (SM-FES)Patients will receive self-modulated functional electrical stimulation SM-FES
Standard care (SC)	Active comparator	Other: Standard CarePatients will receive standard care, dose matched to the experimental group therapy

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (12 listed)

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);

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
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.	Device	Self modulated functional electrical stimulation (SM-FES)
Standard CareThe patient performs intensive, goal-oriented, repetitive functional exercises. Duration: 90 min per day, 5 days per week, for 2 weeks.	Other	Standard care (SC)

Primary outcome

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.

5 secondary outcomes

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)
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
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
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
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

Results and safety

The study was stopped early (reason given: * Challenges experienced in recruitment. * Shifts in the sponsor's priorities and organizational structure resulting from its integration into a larger corporate group.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
Individual participant dataSharing planned: Undecided

Related trials for Stroke Rehabilitation

RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
Recruiting
Telerehabilitation In The Home After Stroke
Stroke
Enrolling by invitation
AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke
Spinal Cord Injuries (SCI)
Active, not recruitingObservational study
Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
Stroke, Acute, Gait, Hemiplegic

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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Self-modulated functional electrical stimulation (SM-FES) in people with Stroke Rehabilitation, run by Intento SA at 4 sites in Switzerland.

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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. 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?

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?

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)). 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 NCT04014270.

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 24 May 2023.