Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle: Healthy or Deprived of Central Nervous System Control
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in knee joint extensors peak torque (Newton-Meters)
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in knee joint extensors peak torque (Newton-Meters)
Time Frame: Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation
Quadriceps muscle strength, measured by isokinetic dynamometry
Change in knee joint flexors peak torque (Newton-Meters)
Time Frame: Change from baseline knee joint flexors peak torque at end of intervention, completed 8 weeks after initiation
Quadriceps muscle strength, measured by isokinetic dynamometry
Change in thigh perimeter (centimeters)
Time Frame: Change from baseline thigh perimeter at end of intervention, completed 8 weeks after initiation
Quadriceps muscle integrity, measured by thigh volumetry
Change in rectus femoris thickness (centimeters)
Time Frame: Change from baseline rectus femoris thickness at end of intervention, completed 8 weeks after initiation
Rectus femoris muscle structural integrity, measured by ultrasound
Change in vastus intermedius thickness (centimeters)
Time Frame: Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation
Vastus intermedius muscle structural integrity, measured by ultrasound
Secondary Outcomes
- System Usability Score(System usability at end of intervention, completed 8 weeks after initiation)
- Adverse effects inventory(Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation)
- Patients Perception of Treatment Outcomes Score(Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation)