Quadriplegia
Conditions
Interventions
This is a pilot study of a single-blind, randomized controlled crossover clinical trial. The study will now include 20 volunteers, 10 healthy individuals and 10 with spinal cord injury. This group wil
E05.723.402
L01.224.160.875
Sponsors
Instituto de Ensino e Pesquisa Alberto Santos Dumont
Universidade Federal do Espirito Santo (UFES)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
Conselho Nacional de Desenvolvimento Científico e Tecnológico. (CNPq)
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Individuals diagnosed with traumatic spinal cord; injury classified as having complete or incomplete tetraplegia (ASIA); with neurologic levels C4–C7; aged between 18 and 60 years; of both sexes; who exhibit some level of motor deficit in the upper limbs and possess adequate cervical control to support the use of virtual reality devices; individuals who are able to attend the intervention site
Exclusion criteria
Exclusion criteria: Participants presenting symptoms of dysautonomia and postural hypotension; presence of skin lesions; uncontrolled pain in the upper limbs; inadequate cervical control for supporting virtual reality devices for an appropriate duration; contractures and/or spasticity(classified by the modified Ashworth scale as grade 2 or higher); surgical procedures (e.g., tendon transfers) or orthopedic trauma (e.g., fracture) within the past 3 months; mechanical ventilation and participants unable to comprehend the information provided in the informed consent or unable to provide valid consent will be excluded; individuals who experience significant discomfort during the proposed activities; those who miss two consecutive sessions; or three alternating sessions during the intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As a primary outcome, we expect a favorable evolution according to the questionnaires considered for clinical assessment and upper limb functionality, as well as the electroencephalographic analyses described in the data analysis section | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes, we expect a favorable evaluation of the safety and usability of the intervention through adverse events and specific questionnaires, and to understand possible correlations between clinical outcomes, BCI performance, and sensorimotor rhythm modulation | — |
Countries
Brazil
Contacts
Public ContactDenis Delisle-Rodriguez
Instituto de Ensino e Pesquisa Alberto Santos Dumont
Outcome results
None listed