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NCT04221373 · ClinicalTrials.gov registry record · NA
Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT04221373: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04221373 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04221373, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this research study is to test the effect of early exoskeletal-assisted walking (EAW) training (combined into regular acute inpatient rehabilitation (AIR)) on improving functional recovery and reducing pain and inflammation. Powered exoskeletons are a technology that offer standing and walking for certain persons with spinal cord injury (SCI) who meet the using indication of the device and have been used in the chronic SCI population with positive benefits in ability to move, daily function (such as bathing and dressing), body composition (such as lean and fat tissue mass), and quality of life (QOL). Despite the potential for EAW to promote functional recovery and reduce secondary medical complications (such as urinary tract infections and pain), no reports exist on the use of exoskeletons in AIR.
Primary Outcome
Functional activities will be assessed using Spinal Cord Independence Measure (SCIM) scores evaluated by clinicians. Full Scale range from 0-100, higher score indicates more independence. Each subscale score is evaluated within the 100-point scale (self-care: 0-20; respiration and sphincter (R \& S) management: 0-40; mobility: 0-40)
Interventions
- OTHER Standard of care
- DEVICE Ekso™ powered exoskeleton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2022-09-13 |
| Phase | NA |
What the finished NCT04221373 record still lists
NCT04221373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT04221373 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04221373 about?
NCT04221373 is a clinical study titled "Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation". The purpose of this research study is to test the effect of early exoskeletal-assisted walking (EAW) training (combined into regular acute inpatient rehabilitation (AIR)) on improving functional recovery and reducing pain and inflammation. Powered exoskeletons are a technology that offer standing an...
What is the current status of trial NCT04221373?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2019-09-30. Estimated completion is 2022-09-13.
What interventions are being tested in trial NCT04221373?
The interventions under investigation include: Standard of care (OTHER), Ekso™ powered exoskeleton (DEVICE).
Who is sponsoring clinical trial NCT04221373?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04221373's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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