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Exoskeleton

Exoskeletal-assisted walking training group for Inpatient

N/A
Waitlist Available
Led By Ann M. Spungen, Ed.D.
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and discharge from acute inpatient rehabilitation (average 2-3 weeks)
Awards & highlights

Study Summary

This trial is testing whether early EAW is helpful for people with SCI when combined into regular AIR.

Eligible Conditions
  • Inpatient
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and discharge from acute inpatient rehabilitation (average 2-3 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and discharge from acute inpatient rehabilitation (average 2-3 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Spinal Cord Independence Measure (SCIM) Version III Scores
Secondary outcome measures
Change in International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) 2.0
Change in International Standards for Neurological Classification of SCI (ISNCSCI)
Number of Participants With Neuropathic Pain

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exoskeletal-assisted walking training groupExperimental Treatment2 Interventions
Participants will receive locomotor training provided with an Ekso™ powered exoskeleton according to the standard of care of AIR at Mount Sinai Hospital with the exception that the EAW training will be incorporated into the designated therapy times (3 hours of physical therapy (PT) and/or occupational therapy (OT)) which will be provided as determined by the clinical team from the earliest time they are identified to be able to safely stand, through discharge. The goal of EAW intervention is to complete three or more sessions of EAW training a week during the AIR period (after enrolling into the study until discharge).
Group II: Standard of care groupActive Control1 Intervention
Participants will receive standard of care of acute inpatient rehabilitation which includes three hours of physical therapy and/or occupational therapy per day until they are discharged.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ekso™ powered exoskeleton
2019
N/A
~40

Find a Location

Who is running the clinical trial?

New York State Department of HealthOTHER_GOV
34 Previous Clinical Trials
447,065 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
861 Previous Clinical Trials
525,244 Total Patients Enrolled
Ann M. Spungen, Ed.D.Principal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation
Ann M. Spungen EdD 2019. "Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04221373.
~6 spots leftby Apr 2025
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