Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle

May 24, 2023 updated by: University of Sao Paulo General Hospital

Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle: Healthy or Deprived of Central Nervous System Control

Feasibility study of a new medical device that will evaluate the usability and effectiveness of a cycle ergometer device associated with neuromuscular electrical stimulation (FES cycling). The study's objective is to evaluate the effect of the application of functional electrical stimulation of the new device on participants' quadriceps muscle strength in comparison to a medical device with similar characteristics and to a control group. Secondarily, the study will compare the usability of the two medical devices as evaluated by the participants and the therapists who apply the treatment, as well as the participants' satisfaction with the treatment, identifying possible adverse effects.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

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

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04116-030
        • Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo

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:

  • Spinal cord injury, brain injury or acquired muscle weakness
  • Managed chronic diseases
  • No contraindications to the practice of physical exercise
  • Ability to communicate in oral and written Portuguese

Exclusion Criteria:

  • Amputation of lower limbs at any level
  • Unstable or acute fractures of lower limbs
  • Contraindication for the practice of physical activity
  • Open wounds in the lower limbs
  • Consent withdraw

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental FES cycling
New medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling)
Device: Experimental FES cycling
Using the experimental, new FES cycling device, provide neuromuscular electrical stimulation of the gluteal, quadriceps and hamstring muscles at sufficient intensity to cause muscle contraction and push the cycle ergometer pedals for 30 minutes, for 16 treatment sessions (twice a week, for 8 weeks), in addition to conventional physical therapy for muscle strengthening.
Active Comparator: Comparator FES cycling
Existing medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling)
Device: Comparator FES cycling
Using the comparator, marketed FES cycling device, provide neuromuscular electrical stimulation of the gluteal, quadriceps and hamstring muscles at sufficient intensity to cause muscle contraction and push the cycle ergometer pedals for 30 minutes, for 16 treatment sessions (twice a week, for 8 weeks), in addition to conventional physical therapy for muscle strengthening.
Active Comparator: Conventional physical therapy
Conventional physical therapy.
Other: Conventional physical therapy
Conventional physical therapy for muscle strengthening, for 16 treatment sessions (twice a week, for 8 weeks).
No Intervention: Operators
Operators will evaluate systems usability during interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in knee joint extensors peak torque (Newton-Meters)
Time Frame: Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation
Quadriceps muscle strength, measured by isokinetic dynamometry
Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation
Change in knee joint flexors peak torque (Newton-Meters)
Time Frame: Change from baseline knee joint flexors peak torque at end of intervention, completed 8 weeks after initiation
Quadriceps muscle strength, measured by isokinetic dynamometry
Change from baseline knee joint flexors peak torque at end of intervention, completed 8 weeks after initiation
Change in thigh perimeter (centimeters)
Time Frame: Change from baseline thigh perimeter at end of intervention, completed 8 weeks after initiation
Quadriceps muscle integrity, measured by thigh volumetry
Change from baseline thigh perimeter at end of intervention, completed 8 weeks after initiation
Change in rectus femoris thickness (centimeters)
Time Frame: Change from baseline rectus femoris thickness at end of intervention, completed 8 weeks after initiation
Rectus femoris muscle structural integrity, measured by ultrasound
Change from baseline rectus femoris thickness at end of intervention, completed 8 weeks after initiation
Change in vastus intermedius thickness (centimeters)
Time Frame: Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation
Vastus intermedius muscle structural integrity, measured by ultrasound
Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Score
Time Frame: System usability at end of intervention, completed 8 weeks after initiation
Systems usability, measured by self-referred survey (0-100, the higher the score, the better the outcome)
System usability at end of intervention, completed 8 weeks after initiation
Patients Perception of Treatment Outcomes Score
Time Frame: Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation
Satisfaction, measured by self-referred survey (6-30, the higher the score, the better the outcome)
Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation
Adverse effects inventory
Time Frame: Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation
Qualitative evaluation of adverse effects, if any
Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation

Collaborators and Investigators

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

Sponsor

University of Sao Paulo General Hospital

Collaborators

Agência Brasileira de Desenvolvimento Industrial (Brazilian Agency For Industrial Development)

Investigators

  • Principal Investigator: Linamara R. Battistella, MD, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2023

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 64324122.0.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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