Descriptive clinical case study
An individual with sequelae of tetraparesis secondary to chronic spinal cord injury were sought among the patients in regular care at the Polyclinic of the Methodist University of São Paulo. Inclusion criteria were having tetraparesis secondary to chronic spinal cord injury, being older than 18 years old, being under medical follow-up for the condition, and following the prescribed medical guidelines. The exclusion criteria were to have some non-compensated clinical condition, having a pressure ulcer, having a metallic implant in the skull, having seizure episodes, and having a pacemaker. The patient was invited to participate in this study through an interview with the responsible researcher, where the research characteristics and the Informed Consent Form were presented.
The study was conducted in the neurology section of the Polyclinic of the Methodist University of São Paulo.
The study was submitted to the Ethics and Research Committee of the Methodist University of São Paulo according to resolution 466/12 and was approved (CAAE: 56549222.6.0000.5508). This study was performed in accordance with relevant guidelines/regulations, and informed consent was obtained from all participants and/or their legal guardians. This study was submitted in the Brazilian Clinical Trials Registry (ReBec - REBEC (ensaiosclinicos.gov.br)) in the data of 28/05/2023 with trial number 14330 (and submit id 14145) and is in the analysis process according to the WHO International Clinical Trial Registry Platform.
Material
The data referring to the anamnesis, name, age, date of birth, sex, address, telephone, history of the current disease, and history of previous disease were recorded on a printed form and transferred to digital form. The scale evaluations that were applied were the Functional Independence Measure (FIM) 31, printed on paper, and the American Spinal Injury Association (ASIA) assessment 6, which was also printed on paper to be duly completed.
The Functional Independence Measure (FIM) 31 is a scale applied to several clinical pictures in order to characterize the degree of independence of an individual in his daily tasks, such as hygiene and feeding, as well as the degree of assistance required, should this be the case. The scale has 18 items (tasks) that encompass motor and cognitive characteristics and that must be answered through a scale from 0 to 7, indicating the degree of assistance or independence to perform each of the indicated tasks 31.
The American Spinal Injury Association (ASIA) assessment 6 is a standardized scale for the assessment of spinal cord injury, with a validated Portuguese version. The ASIA scale allows for a quantitative assessment of the spinal cord injury, identifying the type of injury, sensory and motor level, sensory and motor indices, and partial preservation zone, in order to characterize the physiological and physical condition of the individual with spinal cord injury 6.
The evaluation of Clinical Posturography was performed through the Wii Balance Board ® Platform coupled to a Windows ® computer with the Brain Blox ® Program installed to capture data from the platform, and having the Elipse ® Program of the Lucy Montoro Network for processing the signal from the platform captured by Brain Blox ® Program, in order to extract the kinetic data of the postural evaluation. The postural evaluations were performed in the sitting position, with the patient on a bench and on this platform, where the patient was positioned, with support for the hands and feet on the floor, with the ankles, knees, and hips at 90º flexion. The Sensory Organization Test (SOT) was performed through four sensory conditions. Condition 1, eyes open and fixed platform; condition 2, eyes closed and fixed platform; condition 4, eyes open and moveable platform (cushion); and condition 5, eyes closed and moveable platform (cushion), following the standardization of this test. Conditions 3 and 6 are conditions that require visual apparatus that were not currently available in the actual study. The Functional Reach Test was also performed on the force platform in the sitting position, and for this, data were collected from the force platform and the performance of the test, which was obtained by the maximum distance achieved in the anterior displacement of the body. The Functional Reach Test was performed in the sitting position with arms flexed at 90o, and the patient asked to go as far forward as possible without unbalancing, and the maximum distance from the initial position of the index finger and the final position was measured in addition to the data collected from the platform.
Galvanic Vestibular Stimulation was performed using the NKL ® Non-Invasive Neuromodulation equipment, model MicroEstim Tes 32, with the random noise stimulation (RNS) current. The current was applied through silicone electrodes placed on a sponge surface soaked in 0.9% saline solution. The electrodes were each placed on a mastoid behind the ears and connected to the equipment through the equipment's own cables.
The Human-Human Interface is an apparatus developed by the innovation company Backyard Brains ® (https://backyardbrains.com) and consists of an Arduino configured with an artificial intelligence algorithm, connected to an electroneuromyography channel to electrostimulation equipment and a power source (9V battery or computer). The Arduino was connected to the individual in the target region through cables and self-adhesive surface electrodes for electroneuromyography, in our study, in the rectus abdominal muscles, and connected to the Transcutaneous Electrical Nerve Stimulation (tens) equipment, which through an electrical current is able to stimulate the sense and the contraction of a second muscle group, in a secondary target region, guided by the initial electroneuromyography. We placed the electroneuromyography electrodes on the rectus abdominis muscle and the stimulation electrodes on the paravertebral musculature of the low cervical spine above the lesion segment.
Procedure
The intervention phase had 13 sessions, with two initial evaluation sessions and a therapeutic test, ten intervention sessions, and a reevaluation session at the end. The initial evaluation sessions included a medical history, clinical evaluation, Functional Independence Measure (FIM), and the American Spinal Injury Association (ASIA) assessment on one day, lasting about 1 hour, and Clinical Posturography and Therapeutic Proof on the second day, lasting about 1 hour. The initial assessment was in two days to not fatigue the patient. The Therapeutic Proof was done with the patient sitting on the force platform, with the Galvanic Vestibular Stimulation and the Human-Human Interface connected concomitantly to the patient. We stimulated the patient with increasing intensity through the Noise Vestibular Galvanic Stimulation in periods of 2 minutes each, starting at 0.3 and going up to a maximum of 1.3 mA, while collecting data in the Clinical Posturography in order to find the dosimetry that optimizes postural control in the sitting position.
Once the ideal dose for stimulation was found, it initiated the course of 10 intervention sessions with the galvanic vestibular stimulation and human-human interface equipment and customized vestibular rehabilitation and neurofunctional physiotherapy exercises.
The series of evaluations, sessions, and reevaluation were carried out with sessions three times a week at a predefined time. The reevaluation session was performed at the end, and the data from the clinical evaluation, the Functional Independence Measure (FIM) and American Spinal Injury Association (ASIA) assessment, and the Clinical Posturography, with the two selected tests, Sensory Organization Test and Functional Reach Test, were collected.
Data analysis
The data analysis descriptively compared the initial and final evaluations of the scales and tests. As the patient selected was the same as in the previous study performed 11, the initial assessment of this actual and second study compared to the initial and final assessments of the first study, thus observing the follow-up of these procedures.