Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle

University of Sao Paulo General Hospital15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries Brain Injuries Muscle Atrophy

Interventions

Experimental FES cyclingDEVICE

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.

Comparator FES cyclingDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in knee joint extensors peak torque (Newton-Meters)

Quadriceps muscle strength, measured by isokinetic dynamometry

Time frame: 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)

Quadriceps muscle strength, measured by isokinetic dynamometry

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

Change in thigh perimeter (centimeters)

Quadriceps muscle integrity, measured by thigh volumetry

Time frame: Change from baseline thigh perimeter at end of intervention, completed 8 weeks after initiation

Change in rectus femoris thickness (centimeters)

Rectus femoris muscle structural integrity, measured by ultrasound

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

Change in vastus intermedius thickness (centimeters)

Vastus intermedius muscle structural integrity, measured by ultrasound

Time frame: Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation

Secondary Outcomes

System Usability Score

Systems usability, measured by self-referred survey (0-100, the higher the score, the better the outcome)

Time frame: System usability at end of intervention, completed 8 weeks after initiation

Patients Perception of Treatment Outcomes Score

Satisfaction, measured by self-referred survey (6-30, the higher the score, the better the outcome)

Time frame: Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation

Adverse effects inventory

Qualitative evaluation of adverse effects, if any

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