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NCT01701388 · ClinicalTrials.gov registry record · NA
EKSO Trial: Powered Exoskeleton for Ambulation in Subjects With Spinal Cord Injury (SCI)
A NA study of Spinal Cord Injuries or Similar Neurological Weakness, sponsored by Shirley Ryan AbilityLab.
- Active
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01701388: Active NA study of Spinal Cord Injuries or Similar Neurological Weakness, sponsored by Shirley Ryan AbilityLab.
NCT01701388 is a NA study of Spinal Cord Injuries or Similar Neurological Weakness that is active but no longer recruiting, run by Shirley Ryan AbilityLab. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01701388, a NA study of Spinal Cord Injuries or Similar Neurological Weakness, is active but no longer recruiting, sponsored by Shirley Ryan AbilityLab.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This study seeks to test the safety and efficacy of the Esko device in SCI population and in populations with similar neurological weakness to the SCI population. The device can currently stand from a seated position, walk, and turn and sit down. Our hypothesis are as follows: * Hypothesis 1: We hypothesize that the Ekso subject will significantly improve balance while wearing the device as noted by subject's ability to safely achieve standing balance for 30 sec without loss of balance. * Hypothesis 2: We hypothesize that the Ekso subject will display improved ability to safely ambulate 10 meters to be assessed using the 10 meter walk test. * Hypothesis 3: We hypothesize that the Ekso subject will display improved weight shift in both static and dynamic activities as determined by a trained physical therapist. * Hypothesis 4: We hypothesize that the Ekso subject will verbalize improved success with training of the device as noted by subjective questionnaires that will be assessed following each training session.
Primary Outcome
The goal is to cover as much ground as possible over 6 minutes, the distance is measured with a measuring wheel. The instructions are "Walk continuously if possible, but do not be concerned if you need to slow down or stop to rest." At the end of 6 minutes the participant is asked to rate their exertion level on a Borg Scale of 6 - 20 points. The maximal oxygen consumption (VO2 MAX) data is collected during the test every 10 seconds
Conditions Studied
Interventions
- DEVICE Ekso exoskeleton
Study Locations (1)
Illinois
- Rehabilitation Institute of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-05 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the registry record for NCT01701388 still lists
NCT01701388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Spinal Cord Injuries or Similar Neurological Weakness appearing as the primary indexed condition, and to 1 intervention - of which Ekso exoskeleton is the first listed.
NCT01701388 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01701388 about?
NCT01701388 is a clinical study titled "EKSO Trial: Powered Exoskeleton for Ambulation in Subjects With Spinal Cord Injury (SCI)". This study seeks to test the safety and efficacy of the Esko device in SCI population and in populations with similar neurological weakness to the SCI population. The device can currently stand from a seated position, walk, and turn and sit down. Our hypothesis are as follows: * Hypothesis 1: We hy...
What is the current status of trial NCT01701388?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2012-05. Estimated completion is 2025-12-31.
What conditions does trial NCT01701388 study?
This clinical trial studies the following conditions: Spinal Cord Injuries or Similar Neurological Weakness.
What interventions are being tested in trial NCT01701388?
The interventions under investigation include: Ekso exoskeleton (DEVICE).
Who is sponsoring clinical trial NCT01701388?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01701388 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01701388's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 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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