Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle

Study 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.

Official Title
-----------------
Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle: Healthy or Deprived of Central Nervous System Control

Conditions
-----------------
Spinal Cord Injuries, Brain Injuries, Muscle Atrophy

Intervention / Treatment
-----------------
* Device: Experimental FES cycling
* Device: Comparator FES cycling
* Other: Conventional physical therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental FES cycling<br>New medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling) | Device: Experimental FES cycling<br>* 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.<br>|
| Active Comparator: Comparator FES cycling<br>Existing medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling) | Device: Comparator FES cycling<br>* 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.<br>|
| Active Comparator: Conventional physical therapy<br>Conventional physical therapy. | Other: Conventional physical therapy<br>* Conventional physical therapy for muscle strengthening, for 16 treatment sessions (twice a week, for 8 weeks).<br>|
| No Intervention: Operators<br>Operators will evaluate systems usability during interventions. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knee joint extensors peak torque (Newton-Meters) | Quadriceps muscle strength, measured by isokinetic dynamometry | 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 | 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 | 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 | 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 | Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Score | Systems usability, measured by self-referred survey (0-100, the higher the score, the better the outcome) | 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) | Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation | 
| Adverse effects inventory | Qualitative evaluation of adverse effects, if any | Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation |