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Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle

NCT05888714 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-06-05

No results posted yet for this study

Summary

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.

Conditions

  • Spinal Cord Injuries
  • Brain Injuries
  • Muscle Atrophy

Interventions

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.

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.

OTHER

Conventional physical therapy

Conventional physical therapy for muscle strengthening, for 16 treatment sessions (twice a week, for 8 weeks).

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Linamara R. Battistella, MD, PhD · University of Sao Paulo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-09-01
Completion
2023-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05888714 on ClinicalTrials.gov