Brain Injuries, Muscle Atrophy, Spinal Cord Injuries
Conditions
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.
Interventions
DEVICEExperimental FES cycling
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.
DEVICEComparator FES cycling
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.
OTHERConventional physical therapy
Conventional physical therapy for muscle strengthening, for 16 treatment sessions (twice a week, for 8 weeks).
Sponsors
Agência Brasileira de Desenvolvimento Industrial (Brazilian Agency For Industrial Development)
University of Sao Paulo General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vastus intermedius thickness (centimeters) | Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation | Vastus intermedius muscle structural integrity, measured by ultrasound |
| Change in knee joint flexors peak torque (Newton-Meters) | 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) | 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) | 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 knee joint extensors peak torque (Newton-Meters) | Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation | Quadriceps muscle strength, measured by isokinetic dynamometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients Perception of Treatment Outcomes Score | Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation | Satisfaction, measured by self-referred survey (6-30, the higher the score, the better the outcome) |
| Adverse effects inventory | Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation | Qualitative evaluation of adverse effects, if any |
| System Usability Score | System usability at end of intervention, completed 8 weeks after initiation | Systems usability, measured by self-referred survey (0-100, the higher the score, the better the outcome) |
Countries
Brazil
Contacts
Primary ContactAndré T. Sugawara, MD, PhD
Backup ContactVinicius D. Ramos
Outcome results
None listed