Upper Motor Neuron Disease
Conditions
Keywords
functional electrical stimulation, muscle fatigue, rehabilitation, spinal cord injury, stroke, multiple sclerosis
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.
Interventions
DEVICESDSS
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.
DEVICEStandard Electrical Stimulation During Functional Electrical Stimulation
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.
Sponsors
UGECAM Rhône-Alpes
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average quadriceps power output (watts) measured during 3 minutes of FES cycling | during sessions of FES cycling | The subjects are installed on a Hepha Bike electrostimulation bike, equipped with force-torque measuring pedals (ICS\_RM, Sensix, France), synchronized with a MotiMove-8 stimulator. The average quadriceps power (watts) during the first and last 30 seconds of each stimulation phase, as well as the total average power (Pm) are calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the comfort of dry and hydrogel based functional electrical stimulation electrodes | before the first session of FES cycling | Dry electrode then hydrogel electrode are placed on the quadriceps' motor point The amplitude of stimulation is increased in steps of 3 mA followed by 5 seconds of rest for subsequent trains until the subject feels a burning sensation. the stimulation threshold (mA) is compared between dry and hydrogel electrode |
Countries
France
Outcome results
None listed