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NCT02128152 · ClinicalTrials.gov registry record · NA
Mobility Training Using Exoskeletons for Functional Recovery After Stroke
A NA study of Severe Stroke or Similar Neurological Muscle Weakness, sponsored by Shirley Ryan AbilityLab.
- Active
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT02128152: Active NA study of Severe Stroke or Similar Neurological Muscle Weakness, sponsored by Shirley Ryan AbilityLab.
NCT02128152 is a NA study of Severe Stroke or Similar Neurological Muscle Weakness that is active but no longer recruiting, run by Shirley Ryan AbilityLab. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02128152, a NA study of Severe Stroke or Similar Neurological Muscle Weakness, is active but no longer recruiting, sponsored by Shirley Ryan AbilityLab.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the safety and effectiveness of the Ekso robotic exoskeleton in persons affected by a severe stroke. * Primary Objectives: * To determine if a structured high-dosage exoskeleton training program (EXTP) results in clinically significant gains in walking recovery in individuals affected by severe stroke. * To determine whether timing of EXTP delivery (i.e., sub-acute vs. chronic) and severity (non-ambulators vs. limited house-hold ambulators) affects the improvement in gait speed and overall function following the EXTP training protocol. * To determine whether maintenance or further improvement in gait speed can be achieved by an intensive follow-up program of either a traditional rehabilitation program (TRP) or extended EXTP. * Secondary Objectives: * To determine the effect on functional walking endurance as assessed by the 6 minute walk test and 10 meter walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals. * To determine the effect on functional balance, as assessed by the Berg Balance Scale, Functional Gait Assessment and Five times sit to stand measure as assessed by the 6 minute walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals. * To determine the effect on stroke recovery, as assessed by the step counter of task specific training in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting
Primary Outcome
The 6MWT measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change distance for people with sub-acute stroke is 60.98 meters15. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and r
Conditions Studied
Interventions
- DEVICE Ekso exoskeleton
Study Locations (1)
Illinois
- Rehabilitation Institute of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-02 |
| Est. Completion | 2025-12 |
| Phase | NA |
What the registry record for NCT02128152 still lists
NCT02128152 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Severe Stroke or Similar Neurological Muscle Weakness appearing as the primary indexed condition, and to 1 intervention - of which Ekso exoskeleton is the first listed.
NCT02128152 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02128152 about?
NCT02128152 is a clinical study titled "Mobility Training Using Exoskeletons for Functional Recovery After Stroke". The purpose of this study is to assess the safety and effectiveness of the Ekso robotic exoskeleton in persons affected by a severe stroke. * Primary Objectives: * To determine if a structured high-dosage exoskeleton training program (EXTP) results in clinically significant gains in walking reco...
What is the current status of trial NCT02128152?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2014-02. Estimated completion is 2025-12.
What conditions does trial NCT02128152 study?
This clinical trial studies the following conditions: Severe Stroke or Similar Neurological Muscle Weakness.
What interventions are being tested in trial NCT02128152?
The interventions under investigation include: Ekso exoskeleton (DEVICE).
Who is sponsoring clinical trial NCT02128152?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02128152 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 NCT02128152's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 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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