Exoskeleton Rehabilitation on TBI

Completed

Conditions studied: Traumatic Brain Injury, Cerebral Stroke

In brief

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.

Key facts

Study ID: NCT04465019
Run by: DHR Health Institute for Research and Development
People needed: 77
Starts: 2019-09-25
Expected to finish: 2020-12-31
Last updated by the study team: 2021-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
Patient must have suffered a traumatic brain injury or stroke

You may not qualify if…

Patients were excluded if their injury type was outside the scope of the current study.

Where it is running

DHR Health Rehabilitation Hospital — Edinburg, Texas, United States

Full record on ClinicalTrials.gov

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