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NCT04047992 · ClinicalTrials.gov registry record · NA
Seated Balance Using the Indego™
A NA study of Spinal Cord Injuries, sponsored by James J. Peters Veterans Affairs Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04047992 is a NA study of Spinal Cord Injuries that is actively recruiting participants, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 20 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04047992, a NA study of Spinal Cord Injuries, is actively recruiting participants, sponsored by James J. Peters Veterans Affairs Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Exoskeleton-assisted walking (EAW) provides a new mobility option and appears to have potential therapeutic benefits for persons with SCI. However, present day technology is not sufficient to replace the wheelchair. During EAW, users stand upright, maintain static and dynamic balance by actively and passively stimulating trunk and lower limb muscles in a manner not challenged during wheelchair use. Preliminary results in our laboratory suggest that the indirect balance challenges and postural perturbations that result during EAW training transfer to better seated balance control, resulting in more independence during seated activities. The purpose of this pilot study is to determine the effects of EAW training on various measures of seated balance (primary outcomes) and body composition (secondary outcomes). Twenty people with SCI (T4 and below) who are wheelchair users for mobility and cannot walk independently will be recruited. The participants will receive 36 sessions of EAW training in 12 weeks. The outcomes will be evaluated pre (baseline) and post (24 and 36 sessions). If EAW devices can be demonstrated to help people with SCI have better seated balance, in addition to the other potential benefits that are being investigated elsewhere, then exoskeletons may have the possibility to be more readily accepted in the clinical, home environments, and by the insurance companies.
Conditions Studied
Interventions
- DEVICE Indego™ Exoskeleton
Study Locations (1)
New York
- James J. Peters VA Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04047992
The ClinicalTrials.gov registry entry for NCT04047992 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (67% lower). The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 1 intervention - of which Indego™ Exoskeleton is the first listed.
NCT04047992 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04047992 about?
NCT04047992 is a clinical study titled "Seated Balance Using the Indego™". Exoskeleton-assisted walking (EAW) provides a new mobility option and appears to have potential therapeutic benefits for persons with SCI. However, present day technology is not sufficient to replace the wheelchair. During EAW, users stand upright, maintain static and dynamic balance by actively and...
What is the current status of trial NCT04047992?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2018-02-01. Estimated completion is 2025-12-31.
What conditions does trial NCT04047992 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT04047992?
The interventions under investigation include: Indego™ Exoskeleton (DEVICE).
Who is sponsoring clinical trial NCT04047992?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04047992 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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