Development of a Brain-controlled Gait Apparatus to restore the walking of people with Spinal Cord Injury

Not Applicable

• Conditions: Spinal cord injury sequelae; T91.3

• Registration Number: RBR-2pb8gq
• Lead Sponsor: Associação Alberto Santos Dumont para Apoio à Pesquisa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

18 years old or over; Lesion T4 to L2; SCI AIS A, B, C or D; Presence of chronic, traumatic, six months to 3 years of SCI.

Exclusion Criteria

Has seizures; Has contractures in the legs (shortening of a muscle or tendon); Do not have time for project activities; Participates in other research; Cardiopulmonary instability; Abuse of alcohol or drugs, psychiatric illness, or history of head trauma with loss of consciousness within 3 months of recruitment; Use of drugs known to exert negative effects on motor recovery; Cognitive deficit; Pregnancy or of childbearing potential and not using adequate contraception; Presence of ferromagnetic material in the skull, except in the mouth;
Presence of cardiac and/or neural pacemakers;
Untreated depression; Spasticity at the lower end of a MAS score equal or higher than 2; Uncontrolled diabetes; Severe osteoporosis; Decubitus ulcer that may interfere with the belt placement or any other necessary feature of the LT BWST-assisted robot and the exoskeleton.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EXPECTED: Exoskeleton control by means of the cerebral and muscular electrical activities of the participants, captured non-invasively by EEG/EMG.;OBSERVED: Exoskeleton control by means of the cerebral and muscular electrical activities of the participants captured non-invasively by EEG/EMG. <br>;OBSERVED: Partial neurological recovery demonstrated as the evolution in the AIS score.

Secondary Outcome Measures

Name	Time	Method
EXPECTED: Sensorization of the ICM system through tactile and proprioceptive artificial feedback based on cutaneous space-time stimulation.;EXPECTED: Change in perception of the body schema of the research participants.<br>;OBSERVED: Sensorization of the BMI system through tactile and proprioceptive artificial feedback based on cutaneous space-time stimulation. ;OBSERVED: Change in perception of the body schema of the research participants.<br>;OBSERVED: Improvement of cardiovascular, urinary, intestinal and sexual functions, self-esteem and quality of life of the participants.