Exoskeleton Rehabilitation on TBI

NCT04465019 | Completed FDA Device

• 1 other identifier: 1492252
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury; Cerebral Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Functional Independence Measure

  Increase in FIM from Admission to Discharge

  Ten weeks

Secondary Outcomes (2)

• Number of steps taken in the exoskeleton

  Inpatient stay at the rehabilitation hospital

• Time active in the exoskeleton

  Inpatient stay at the rehabilitation hospital

Study Arms (2)

TBI Group

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.

Device: Exoskeleton Rehabilitation

CVA Group

Subjects in the CVA group included all patients in the hospital that used the EKSO® during their rehabilitation process during their rehabilitation treatment from 01/01/2017 to 04/30/2020.

Device: Exoskeleton Rehabilitation

Interventions

Exoskeleton Rehabilitation DEVICE

The EKSO GT® was operated by a Licensed Physical Therapist who was certified to control the device. We followed a strictly established protocol for operating the device during the rehabilitation process as established by the company.

CVA Group; TBI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 66 (10.7%) and 11 (7.9%) patients met the criteria and agreed to use the exoskeleton for CVA and TBI respectively. More than 90% of the study population is of Hispanic ethnicity.

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.

Sponsors & Collaborators

• DHR Health Institute for Research and Development: lead

Study Sites (1)

DHR Health Rehabilitation Hospital

Edinburg, Texas, 78539, United States

Location

Related Publications (1)

• Trevino LR, Roberge P, Auer ME, Morales A, Torres-Reveron A. Predictors of Functional Outcome in a Cohort of Hispanic Patients Using Exoskeleton Rehabilitation for Cerebrovascular Accidents and Traumatic Brain Injury. Front Neurorobot. 2021 Jun 10;15:682156. doi: 10.3389/fnbot.2021.682156. eCollection 2021.

  PMID: 34177511 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: September 25, 2019
• Primary Completion: July 3, 2020
• Study Completion: December 31, 2020
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Up to two years after data publication
• Access Criteria: Contact Principal Investigator

Locations

US (1)