Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle

University of Sao Paulo General Hospital

Status: Not yet enrolling

Conditions: Brain Injuries; Muscle Atrophy; Spinal Cord Injuries

Treatments: Device: Experimental FES cycling; Other: Conventional physical therapy; Device: Comparator FES cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT05888714

CAAE 64324122.0.0000.0068

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

Experimental FES cycling

Experimental group

Description:

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

Treatment:

Device: Experimental FES cycling

Comparator FES cycling

Active Comparator group

Description:

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

Treatment:

Device: Comparator FES cycling

Conventional physical therapy

Active Comparator group

Description:

Conventional physical therapy.

Treatment:

Other: Conventional physical therapy

Operators

No Intervention group

Description:

Operators will evaluate systems usability during interventions.