Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients (SDSS_UMS)

UGECAM Rhône-Alpes

Status: Completed

Conditions: Upper Motor Neuron Disease

Treatments: Device: Standard Electrical Stimulation During Functional Electrical Stimulation; Device: SDSS

Study type: Interventional

Funder types: Other

Identifiers

NCT06421753

2024-01-VR

Details and patient eligibility

About

To determine whether Spatially Distributed Sequential Functional Electrical Stimulation is more effective than Standard Electrical Stimulation During Functional Electrical Stimulation in Upper Motor Neuron Patients

Full description

Design: SCED (single case experimental design) prospective, monocentric, comparative interventional study (SDSS versus SES) Population: patients with motor deficit due to upper motor neuron syndrome Setting: Neurologic Rehabilitation Unit Interventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling.

Participants will be evaluated before and during the training.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with Upper Motor Neuron syndrome:

• adult (> 18 years)
• motor deficit due to an acquired traumatic or neurodegenerative motor deficiency of the central nervous system (MRC<4/5)
• stable clinical condition, particularly on the cardiovascular level (recent assessment by a cardiologist with stress test)
• non denervated muscles
• tolerant to muscle electrical stimulation
• having given written consent
• able to cycle 30 minutes with FES-cycling

Exclusion criteria

• major cognitive comprehension disorders that could compromise understanding of the protocol and the smooth running of the study
• cardiac pacemaker and other contraindications relating to the use of electrostimulation (in particularly "deep vein thrombosis")
• spasticity of the lower limbs making flexion/extension movement difficult
• participation in another study
• pregnancy
• people with the following legal and administrative states or situations:
• people placed under judicial protection;
• persons deprived of their liberty, persons subject to psychiatric care and persons admitted to a health or social establishment for purposes other than that of clinical investigation;
• unemancipated minors;
• people who are not affiliated to a social security scheme or beneficiaries of such a scheme

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Spatially Distributed Sequential Functional Electrical Stimulation

Experimental group

Description:

Interventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling.

Treatment:

Device: SDSS

Standard Electrical Stimulation During Functional Electrical Stimulation

Active Comparator group

Description:

Each session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out. During the second session, the order of the stimulation phases is reversed.

Treatment:

Device: Standard Electrical Stimulation During Functional Electrical Stimulation