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

Last updated: May 17, 2024
Sponsor: UGECAM Rhône-Alpes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Treatment

SDSS

Standard Electrical Stimulation During Functional Electrical Stimulation

Clinical Study ID

NCT06421753
2024-01-VR
  • Ages 18-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with Upper Motor Neuron syndrome:

  • adult (> 18 years)

  • motor deficit due to an acquired traumatic or neurodegenerative motor deficiency ofthe central nervous system (MRC<4/5)

  • stable clinical condition, particularly on the cardiovascular level (recentassessment 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

Exclusion Criteria:

  • major cognitive comprehension disorders that could compromise understanding of theprotocol and the smooth running of the study

  • cardiac pacemaker and other contraindications relating to the use ofelectrostimulation (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 personsadmitted to a health or social establishment for purposes other than that ofclinical investigation;

  • unemancipated minors;

  • people who are not affiliated to a social security scheme or beneficiaries of such ascheme

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: SDSS
Phase:
Study Start date:
May 14, 2024
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • SMR Val Rosay

    Saint didier au mont d'or, 69370
    France

    Active - Recruiting

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