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

NCT06421753 | Completed

• 1 other identifier: 2024-01-VR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Upper Motor Neuron Disease

Keywords

functional electrical stimulation; muscle fatigue; rehabilitation; spinal cord injury; stroke; multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Average quadriceps power output (watts) measured during 3 minutes 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.

  during sessions of FES cycling

Secondary Outcomes (1)

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

  before the first session of FES cycling

Study Arms (2)

Spatially Distributed Sequential Functional Electrical Stimulation

EXPERIMENTAL

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.

Device: SDSS

Standard Electrical Stimulation During Functional Electrical Stimulation

ACTIVE COMPARATOR

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.

Device: Standard Electrical Stimulation During Functional Electrical Stimulation

Interventions

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.

Spatially Distributed Sequential Functional Electrical Stimulation

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.

Standard Electrical Stimulation During Functional Electrical Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UGECAM Rhône-Alpes: lead

Study Sites (1)

SMR Val Rosay

Saint-Didier-au-Mont-d'Or, France, 69370, France

Location

MeSH Terms

Conditions

Motor Neuron Disease; Spinal Cord Injuries; Stroke; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: May 16, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)