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Prototyping of a neuromuscular stimulator and transfer of technology for using during hospital stay in the context of Health Unic System of Federal District

Prototyping of a neuromuscular stimulator and transfer of technology for using during hospital stay in the context of Health Unic System of Federal District - Neuromuscular electrical stimulation in patients hospitalized to the intensive care unit: a randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8kdrbz
Enrollment
Unknown
Registered
2016-06-21
Start date
2016-06-27
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury. Critical illness polyneuropathy and myopathy. Muscle Weakness.

Interventions

A prospective, randomized, controlled clinical trial will be conducted to test a new neuromuscular electrical stimulation (NMES) technique in a neurocritical intensive care unit of a tertiary hospital
36(8):1-6. GE, in addition to routine physiotherapy, will undergo a new NMES protocol in the quadriceps femoris, hamstring, gastrocnemius and tibialis anterior muscles. These groups will be followed f
Device
Procedure/surgery
E05.723.402

Sponsors

Secretaria de Estado de Saúde do Distrito Federal
Lead Sponsor
Universidade de Brasília
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients with traumatic brain injury, Age between 18 and 60 years; Patients up to 24 hours of mechanical ventilation.

Exclusion criteria

Exclusion criteria: Patients diagnosed with chronic diabetes mellitus; Patients with previous neuromuscular diseases; Patients with a history of alcohol abuse; HIV; Chronic renal failure; Patients using neurotoxic medications and / or neuromuscular blockers; Spinal cord injury; Pregnancy; Skin lesions in the region to be treated; BMI> 35; Patients with of systemic diseases; Unstable fractures in the lower limbs that prevent the application of NMES.

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of NMES and bed rest on muscle architecture using ultrasound assessment of the thickness and echogenicity of the rectus femoris and tibialis anterior muscles. Ultrasonographic measurements will be performed in B-mode with a 7.5 MHz linear transducer using a portable ultrasound device. The rectus femoris will be assessed at the mean distance between the anterior superior iliac spine and the superior border of the patella. The tibialis anterior will be assessed transversally at the proximal 1/4 of the distance between the inferior border of the patella and the lateral malleolus. The evaluations will be carried out on days 1, 3, 7 and 14.;To assess the effect of NMES and bed rest on functionality and neuromuscular excitability. The neuromuscular excitability will be evaluated from the stimulus electrodiagnosis test and by the evoked torque. The rheobase and chronaxie values of the rectus femoris and tibialis anterior will be measured through stimulus electrodiagnosis test. The test will be conducted at the motor points of these muscles using a 1 cm2 pen-type electrode. Chronaxie values greater than 1000 us will characterize the presence of neuromuscular electrophysiological disorder. The evoked torque will be conducted in the rectus femoris muscle using a load cell coupled to a load platform and a neuromuscular electrical stimulator. These evaluations will be carried out on days 1, 3, 7 and 14.

Secondary

MeasureTime frame
To evaluate the effect of NMES and bed rest on mechanical ventilation time, length of hospital and intensive care unit stay, and mortality rate. These data will be analyzed from the medical records of patients admitted into the study;To evaluate the effect of NMES and bed rest on the inflammatory, catabolic and anabolic response by means of cytokines and metaloproteinases. It will be assessed the cytokines myostatin, IGF-1; TGF-B; Interleukin (IL): IL-1beta, IL-6, IL-8, IL-10 and TNF-alpha. It will be assessed also the metalloproteinases 2 and 9. Blood samples of 12 ml will be collected through the antecubital vein, centrifuged and stored at -80 C°. The blood sample will be collected on days 1, 3, 7 and 14.

Countries

Brazil

Contacts

Public ContactJoão;Paulo Durigan;Silva

Faculdade de Ceilândia - UnB;Universidade de Brasília

joaodurigan@gmail.com;pauloeugenio.bsb@gmail.com+55(61)3107-8421;61996864850

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 1, 2026