Exoskeleton Rehabilitation on TBI
Public ClinicalTrials.gov record NCT04465019. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Use of the Exoskeleton Robotic Device in the Rehabilitation of Traumatic Brain Injury
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04465019
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 77 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 24, 2019
- Primary completion
- Jul 2, 2020
- Completion
- Dec 30, 2020
- Last update posted
- May 26, 2021
2019 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| DHR Health Rehabilitation Hospital | Edinburg | Texas | 78539 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04465019, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 26, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04465019 live on ClinicalTrials.gov.