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

NCT ID: NCT04014270

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-08
• Study Completion Date: 2023-05-22

Brief 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.

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self modulated functional electrical stimulation (SM-FES)

Patients will receive self-modulated functional electrical stimulation SM-FES

Group Type: EXPERIMENTAL

Self-modulated functional electrical stimulation (SM-FES)

Intervention Type: 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 care (SC)

Patients will receive standard care, dose matched to the experimental group therapy

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

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

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

Interventions

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.

Intervention Type: DEVICE

Standard Care

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

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

KLINIK BETHESDA Tschugg

UNKNOWN

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: collaborator

Innosuisse - Swiss Innovation Agency

OTHER

Sponsor Role: collaborator

Intento SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre hospitalier universitaire vaudois

Lausanne, Canton of Vaud, Switzerland

Inselspital

Bern, , Switzerland

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Klinik Bethesda Tschugg

Tschugg, , Switzerland

Countries

Switzerland

Other Identifiers

10000465

Identifier Type: OTHER

Identifier Source: secondary_id

CIV-CH-19-02-027064

Identifier Type: OTHER

Identifier Source: secondary_id

2018-02402

Identifier Type: -

Identifier Source: org_study_id