Clinical trial NCT05888714: Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle
Official title: Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle: Healthy or Deprived of Central Nervous System Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Brain Injuries
Muscle Atrophy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Agência Brasileira de Desenvolvimento Industrial (Brazilian Agency For Industrial Development)
First posted: 2023-06-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in knee joint extensors peak torque (Newton-Meters)
timeFrame: Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation
measure: Change in knee joint flexors peak torque (Newton-Meters)
timeFrame: Change from baseline knee joint flexors peak torque at end of intervention, completed 8 weeks after initiation
measure: Change in thigh perimeter (centimeters)
timeFrame: Change from baseline thigh perimeter at end of intervention, completed 8 weeks after initiation
measure: Change in rectus femoris thickness (centimeters)
timeFrame: Change from baseline rectus femoris thickness at end of intervention, completed 8 weeks after initiation
measure: Change in vastus intermedius thickness (centimeters)
timeFrame: Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation
Secondary outcomes:
measure: System Usability Score
timeFrame: System usability at end of intervention, completed 8 weeks after initiation
measure: Patients Perception of Treatment Outcomes Score
timeFrame: Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation
measure: Adverse effects inventory
timeFrame: Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Linamara R. Battistella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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