Brain Injuries, Traumatic
Conditions
Interventions
This is a prospective feasibility study with a single group, with pre, post and follow-up assessments. The desired sample size is 12 participants. The intervention is performed three times a week for
Switzerland), measurements are taken on the lower limbs for the equipment's medical record and for the patients adjustment to it. In the sessions of the first week, the initial speed used is that obta
E07.341
Sponsors
Universidade Federal do Espirito Santo
Universidade Federal do Espirito Santo
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 50 years old; both sexes; 6 months to 3 years of Traumatic Brain Injury - TBI and classified as severe by the Glasgow Coma Scale (GCS) with a value of 3-8; have a walking speed of 0.2m/s to 0.6m/s assessed by the 10-meter Walk Test (WT10); provide informed consent prior to data collection
Exclusion criteria
Exclusion criteria: Weight over 135 kg. Height greater than 1.90 meters. Femur length less than 35 cm or greater than 47 cm. Unstable cardiovascular disease. Arterial hypertension. Acute myocardial infarction. Acute thromboembolic disease. Patients who have severe contractures in the lower extremities. Bone instability. Non-union fractures. Osteoporosis. Severe discrepancy in the length of the lower limbs. Osteomyelitis. Unhealed skin lesions. It has colostomy bags. It has urinary tract catheters. Mechanical ventilation. Pregnancy. Infections. Inflammatory diseases. Uncontrolled chronic conditions. He suffered a stroke and spinal cord injury. Patient on hemodialysis. Patients who have already undergone training at Lokomat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of recruitment is determined by the proportion of patients with severe TBI who will be contacted and who will be able to meet the inclusion and exclusion criteria being selected for the study, and thus assessing the rates of refusal to participate in the training or the most commonly reported ineligibility.;The feasibility of the intervention is determined by the aspects of adherence, efficiency, acceptability and safety. The first, adherence, will be defined by the proportion of sessions carried out within the 15 planned training sessions. Efficiency is determined by comparing training parameters such as gait speed, driving force and weight support offered at the end of the training protocol. Acceptability is assessed through questions answered in a questionnaire with six yes or no questions and given to the patients. The safety of the training is defined by the number of adverse events that occurred during or after the training, within the total number of sessions to be carried out.;The feasibility of the evaluation involved observing how many participants could be evaluated for all outcomes during the protocol period and in the Follow-Up period, that is, 1 month after the end of the training.;Assessment of resources, such as how many trained physiotherapists were needed to use the equipment, obtaining how much time on average through data from daily reports obtained by Google Forms was needed to place and remove the patient from the equipment, and finally whether any maintenance was carried out on the equipment and, if so, how long it took for the repair to take place. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
Brazil
Contacts
Public ContactJéssica Buarque
Universidade Federal do Espirito Santo
Outcome results
None listed