Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04465019 |
| Other study ID # |
1492252 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 25, 2019 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
May 2021 |
| Source |
DHR Health Institute for Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background: Traumatic brain injury (TBI) is one of the leading causes of disability in the
United States. The EKSO GT Bionics® (EKSO®) is a robotic exoskeleton approved by the Federal
Drug Administration (FDA) for rehabilitation following a cerebrovascular accident (CVA or
stroke) and recently received approval for use in patients with TBI. The aim of the study was
to examine if the use of exoskeleton rehabilitation in patients with TBI will produce
beneficial outcomes. Methods: This retrospective chart-review reports the use of the (EKSO®)
robotic device in the rehabilitation of patients with TBI compared to patients with CVA. The
investigators utilized data from a single, private rehabilitation hospital for patients that
received post-CVA or post-TBI robotic exoskeleton intervention. All patients that used the
exoskeleton were discharged from the hospital between 01/01/2017 to 04/30/2020. Ninety-four
percent (94%) of patients in the CVA groups and 100% of patients in the TBI group were of
Hispanic or Latino ethnicity. Gains in total Functional Independence Measure (FIM), walking
and cognition, and length of stay in the rehabilitation facility were measured. Results:
Patients in the TBI group (n=11) were significantly younger than the patients in the CVA
group (n=66; p< 0.05). Both groups spent a similar amount of time active, number of steps
taken, and the number of sessions in the exoskeleton. Both groups also started with similar
admission FIM scores. The FIM gain in the TBI group was similar to that of the CVA group
(37.5 and 32.0 respectively). The length of stay between groups was not different either.
Conclusions: The use of exoskeleton rehabilitation in patients with TBI appear to produce
similar outcomes as for patients with CVA, prompting further attention of this intervention
for this type of injury.
Description:
Study Design and Setting
This is an observational, retrospective, chart review cohort study of patients from a private
single rehabilitation hospital. Study approval was granted by the local Institutional Review
Board and conformed to the Declaration of Helsinki and the US Federal Policy for the
Protection of Human Subjects. Due to the retrospective nature of the study, a full waiver of
authorization under the Health Insurance Portability and Accountability Act (1996) was
submitted by the study team and approved by the Institutional Review Board.
Participants
Inclusion and Exclusion criteria: Subjects in the TBI group included patients who suffered a
TBI and who used the EKSO® bionic exoskeleton during their rehabilitation treatment from
01/01/2017 to 04/30/2020. Subjects in the CVA group included all patients in the hospital
that used the EKSO® during their rehabilitation process during the same period of the
patients in the TBI group. Patients were excluded if their injury type was outside the scope
of the current study. The registered nurse at the rehabilitation facility identified the
patients based on the inclusion criteria, and this was verified by the doctor in physical
therapy who oversees the rehabilitation hospital patient population. Approval and
implementation of the EKSO® bionic device at the hospital commenced in 2014 for patients that
suffered a CVA and spinal cord injury. Main indications for the use of the EKSO® during
rehabilitation included a height range between 1.56 to 1.9 meters and a patient's weight
equal to or less than 100kg. Stable blood pressure was required, with the ability to follow
one to two steps commands, and the patient should also have demonstrated a normal range of
motion in hips, knees, and ankles.
Variables
Demographic factors considered in this study were age at the time of admission into the
rehabilitation facility (measured in years), and patient's sex (males or females). Ethnicity
was self-reported and collected in the study, but it was not considered as a covariate since
the vast majority of our cohort was of Hispanic origin. The overrepresentation of
Hispanics/Latinos in the current cohort responds to the demographic distribution of the area
the hospital serves. The investigators collected information related to the impairment type
produced by the CVA, and for the TBI; investigators collected the abbreviated injury scale
(ASI) to determine the injury severity score (ISS).
The change in FIM score from admission to discharge was used as the primary outcome for this
study. The FIM score evaluates the ability of the patient in day-to-day functions within
three (3) major categories: self-care, mobility, and communication. To explore whether the
use of EKSO® facilitates the improvement in mobility and communication, investigators also
explored the motor FIM and social interaction FIM, problem-solving FIM, and memory FIM. In
parallel to FIM, investigators evaluated how the length of stay in the facility affected the
outcomes.
Data sources/measurements
Variables collected in this study were retrospectively obtained from the patient's electronic
medical chart. All information presented in this study was part of the patient's standard of
care. No additional intervention or data collection instrument was implemented. The standard
of care of the patient is as follows: all potentially eligible candidates were identified and
cleared by the physician with subsequent patient education regarding the use of the EKSO®.
For the use of the exoskeleton during the rehabilitation process, signed informed consent was
obtained from either the patient or designated family member, depending on the status of the
patient. Data obtained during the active use of the exoskeleton was visualized in the screen
of the EKSO® (time active, steps taken, etc.) and subsequently recorded in each patient's
paper chart. This paper was then scanned and uploaded into the patient's electronic chart
under his/her progress notes. The therapy technicians helped in the data recording process.
All available data related to EKSO use for CVA and TBI at our facility were included in the
current study. The primary goal of the data analysis was to gather preliminary comparative
outcomes that could guide us into designing larger-controlled studies.
Reduction of Bias
To minimize selection bias in the current study, investigators used all patients that were
clinically determined by the attending physician to meet the criteria for exoskeleton
rehabilitation. Patients were included in the chart review regardless of the number of
sessions of exoskeleton use. All therapist and nurses at our facility have been certified to
use the FIM assessment tool and the data is entered using the Uniform Data System for Medical
Rehabilitation (https://www.udsmr.org/) software integrated within the hospital medical
record platform. The main data extractor in the study (A.M.) is the site expert for data
management within the Uniform Data System. Quality of the data was verified by the lead
doctor in Physical Therapy (M.E.A.). None of the patients that used exoskeleton in
rehabilitation had missing data during the time period used for the current study and all
patients in the cohort completed the recommended therapeutic program and were successfully
discharged from the hospital.
Exoskeleton use protocol
The EKSO GT® was operated by a Licensed Physical Therapist who was certified to control the
device. The device is only approved to be used in a clinical setting. For the purposes of
this study, four different modes were utilized to engage and challenge the patients:
Pre-Gait, First Step, Pro Step Plus, and 2 Free. Pre-Gait Mode focused on the following
metrics to facilitate movement and active participation: bilateral weight shifting in
standing with biofeedback, mini squats, and stationary unilateral lower extremity
advancement. The First Step mode allowed the therapist to be in full control of all movement.
The therapist triggered the initiation and execution of each step reciprocally with the push
of a button. In the Pro Step Plus mode, there was an appropriate weight shift either done
independently by the patient or facilitated by the therapeutic handling of the physical
therapist. The patient was given the opportunity to initiate each step; the EKSO® device
completed any incomplete steps. The most advanced mode is called 2 Free. This mode was used
to challenge the patient across the continuum as they progress. The patient was responsible
for initiating and executing each step. The therapist programmed resistance unilaterally or
bilaterally to the lower extremities to increase the demand for the activity.
Statistical methods
Descriptive statistics for the entire study population were generated. Normally distributed
continuous variables were described with means and standard deviations, medians and ranges
were used for non-normally distributed variables, and frequencies and column percentages
summarized categorical variables. Differences in demographic and clinical characteristics
between the two treatment groups were evaluated using Student t-test for independent samples
for normally distributed continuous variables, Mann-Whitney U test for non-normally
distributed continuous variables, and Fisher exact test for categorical variables. To test
for the difference between the CVA and TBI groups in respect to socio-demographic and
treatment measurements, paired t-test or Wilcoxon signed-rank test for continuous variables
and Chi-square test/Fisher exact test for categorical variables were used. Shapiro-Wilk test
for normality was conducted to determine the normality of the continuous variables'
distributions. Linear regression analyses were carried out to evaluate the associations of
each of the outcome variables with age, sex, and length of hospital stay, and with the injury
groups (CVA and TBI) variable. All statistical tests were two-sided and were performed at a
significance level of 0.05. All statistical analyses were conducted using SAS 9.4 (SAS
Institute, Inc, Cary, North Carolina, USA.).
