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

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.

New medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling)

Existing medical device combining cycle ergometer use and neuromuscular electrical stimulation (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.

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.

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

Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation

Change from baseline knee joint flexors peak torque at end of intervention, completed 8 weeks after initiation

Change from baseline rectus femoris thickness at end of intervention, completed 8 weeks after initiation

Change from baseline vastus intermedius thickness 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)

Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation

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

Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo

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