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

May 17, 2024 updated by: UGECAM Rhône-Alpes
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint didier au mont d'or, France, 69370
        • Recruiting
        • SMR Val Rosay
        • Principal Investigator:
          • julie di marco, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during sessions of FES cycling

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before the first session of FES cycling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UGECAM Rhône-Alpes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 14, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-01-VR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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