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

NCT ID: NCT06421753

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2024-12-31

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.

Conditions

Upper Motor Neuron Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Spatially Distributed Sequential Functional Electrical Stimulation

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.

Group Type: EXPERIMENTAL

SDSS

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Standard Electrical Stimulation During Functional Electrical Stimulation

Intervention Type: 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.

Interventions

SDSS

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.

Intervention Type: DEVICE

Standard 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UGECAM Rhône-Alpes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SMR Val Rosay

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

Countries

France

Other Identifiers

2024-01-VR

Identifier Type: -

Identifier Source: org_study_id