Clinical trial NCT04014270: Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke Rehabilitation
Keywords: Electrical stimulation
Upper limb rehabilitation
Hemiplegia
Lead sponsor: Intento SA
Sponsor class: INDUSTRY
Collaborators: name: Centre Hospitalier Universitaire Vaudois
name: University Hospital, Geneva
name: KLINIK BETHESDA Tschugg
name: Insel Gruppe AG, University Hospital Bern
name: University of Bern
name: Innosuisse - Swiss Innovation Agency
First posted: 2019-07-10
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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)
timeFrame: From baseline to post-intervention (2 weeks)
Secondary outcomes:
measure: Change of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale at 3 months (T3) compared to baseline (T0)
timeFrame: At 3 months (T3) compared to baseline (T0)
measure: 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
timeFrame: From baseline (T0) to 2 weeks (T2) post-intervention and 3 months (T3) follow-up
measure: 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
timeFrame: From baseline to post-intervention (2 weeks) and to 3 months follow-up
measure: 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
timeFrame: From baseline to post-intervention (2 weeks) and to 3 months follow-up
measure: 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
timeFrame: From baseline to post-intervention (2 weeks) and to 3 months follow-up
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois
state: Vaud
city: Bern
country: Switzerland
facility: Inselspital
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Tschugg
country: Switzerland
facility: Klinik Bethesda Tschugg
Study officials:
References: