Clinical trial NCT06421753: Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients
Official title: Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Motor Neuron Disease
Keywords: functional electrical stimulation
muscle fatigue
rehabilitation
spinal cord injury
stroke
multiple sclerosis
Lead sponsor: UGECAM Rhône-Alpes
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: SCED : Single Case Experimental Design Each patient is his own control Patient will be randomised to receive FES-cycling with SDSS or standard electrical stimulation
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Average quadriceps power output (watts) measured during 3 minutes of FES cycling
timeFrame: during sessions of FES cycling
Secondary outcomes:
measure: Evaluate the comfort of dry and hydrogel based functional electrical stimulation electrodes
timeFrame: before the first session of FES cycling
Other outcomes:
Locations:
city: Saint didier au mont d'or
country: France
facility: SMR Val Rosay
Study officials:
References: