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Evaluation of the use of orthostatic postural support equipment during work activities in paraplegic and amputee patients

Physiological and occupational parameters and level of satisfaction of paraplegic and amputees submitted to labor activity with or without the use of postural elevation equipment (STEVE) : A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-57w2gxn
Enrollment
Unknown
Registered
2022-01-26
Start date
2021-12-06
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

Paraplegia and tetraplegia

Interventions

The groups of paraplegics, amputees and the control group will consist of 20 individuals each. In each group, individuals will be randomized to the group using the equipment or not using the lifting e

Sponsors

Universidade Estadual do Ceará
Lead Sponsor
Dell Computadores do Brasil Ltda
Collaborator
Universidade Estadual do Ceará
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Adults between 18 and 50 years; both genders; without associated vascular pathologies (clotting disorders, decompensated diabetes, etc.). In the paraplegic group: participants will be included with bilateral lower limb paraplegia; no history of pressure ulcers in the last month in any part of the body; and with stable hemodynamic parameters in the last month (heart rate, blood pressure and oxygen saturation); In the amputee group: patients with lower limb amputations who have been using a prosthesis for at least six months; who are no longer in the process of adapting to prosthesis.

Exclusion criteria

Exclusion criteria: Individuals who present symptoms of dizziness; associated brain neuropathological alterations (cerebrovascular accident, Parkinson's, Alzheimer's and traumatic brain injury); severe cognitive/psychological dysfunction that may interfere with the performance of the tests (panic syndrome, major anxiety or depression crises); individuals with relevant speech impairments that make it impossible for them to communicate during the tests and alterations in arterial pressure.

Design outcomes

Primary

MeasureTime frame
Primary outcome 1: Improvement of ergonomic and psychosocial risks measured through the Brazilian version of the Quick Exposure Check (QEC) in the initial evaluation and after 5 days, at the end of the experiment.

Secondary

MeasureTime frame
Secondary outcome 1: Improvement of ergonomic and psychosocial risks measured by the Brazilian version of the Brief Inventory of Pain questionnaire in the initial evaluation and after 5 days, at the end of the experiment.;Secondary outcome 2: Improvement in the level of satisfaction of volunteers in relation to the environment of the experiments, measured by the Brazilian version of the Occupational Stress Indicator (OSI) questionnaire in the initial assessment and after 5 days, at the end of the experiment.;Secondary outcome 3: Improvement in ergonomic and psychosocial risk during the performance of factory activities assessed by the Brazilian version of the Maastricht Upper Extremity Questionnaire (MUEQ) in the initial assessment and after 5 days, at the end of the experiment.;Secondary outcome 4: Improved performance of participants in the process of assembling computers using postural elevation equipment in the initial assessment and after 5 days, at the end of the experiment.;Secondary outcome 5: Stability or improvement in signs and symptoms of central sensitization assessed by the Brazilian version of the Central Sensitization Inventory (CSI) in the initial assessment and after 5 days, at the end of the experiment.;Secondary outcome 6: Evaluate the brain electrical activity and possible changes in wave patterns, identifying which areas are showing changes resulting from the use of the equipment with the use of quantitative electroencephalography in the initial assessment and after 5 days, at the end of the experiment.;Secondary outcome 7: Improvement or stability of oxygen saturation level, blood pressure and heart rate measured by a finger oximeter and sphygmomanometer in the initial evaluation and after 5 days, at the end of the experiment.;Secondary outcome 8: Improvement in the report of musculoskeletal symptoms assessed by the Nordic Musculoskeletal Questionnaire (NMQ) after 5 days, at the end of the experiment.;Secondary outcome 9: Evaluate the patient'

Countries

Brazil

Contacts

Public ContactFrancisco de Mattos Brito Oliveira
fran.oliveira@uece.br+5585996980222

Outcome results

None listed

Source: REBEC (via WHO ICTRP)