NCT05888714

Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-09-01
• Completion: 2023-12-31
• First posted: 2023-06-05
• Last updated: 2023-06-05

Locations

1 site across 1 country: Brazil