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Completed

NCT Number: NCT06421753

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SDSS

Device

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.

Standard Electrical Stimulation During Functional Electrical Stimulation

Device

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.

Primary outcomes

  1. Average quadriceps power output (watts) measured during 3 minutes of FES cycling

    Time frame: 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 outcomes

  1. Evaluate the comfort of dry and hydrogel based functional electrical stimulation electrodes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

UGECAM Rhône-Alpes

Other

Registry information

Acronym: SDSS_UMS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 20, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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