Status:
TERMINATED
Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis
Lead Sponsor:
Intento SA
Collaborating Sponsors:
Centre Hospitalier Universitaire Vaudois
University Hospital, Geneva
Conditions:
Stroke Rehabilitation
Eligibility:
All Genders
18-80 years
Phase:
NA
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-...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04014270
Start Date
November 8 2019
End Date
May 22 2023
Last Update
May 24 2023
Active Locations (4)
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1
Centre hospitalier universitaire vaudois
Lausanne, Canton of Vaud, Switzerland, 1005
2
Inselspital
Bern, Switzerland, 3010
3
Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1205
4
Klinik Bethesda Tschugg
Tschugg, Switzerland, 3233