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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: Recruiting NA study of Spinal Cord Injuries, sponsored by James J. Peters Veterans Affairs Medical Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Seated balance will be measured by assessment of the limits of stability (LOS) using computerized dynamic posturography (SMART EquiTest, Natus). The SMART EquiTest® system utilizes a dynamic force plate to quantify the vertical forces exerted through the participant's center of gravity as s/he sits on a cushioned block with back unsupported and arms crossed over the clavicles.

Conditions Studied

Interventions

  • DEVICE Indego™ Exoskeleton

Study Locations (1)

New York

  • James J. Peters VA Medical Center - The Bronx

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2018-02-01
Est. Completion 2025-12-31
Phase NA

What NCT04047992 shows while recruiting

NCT04047992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (67% lower).

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 a single indexed study location in 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.

Similar trials for Spinal Cord Injuries

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04047992's enrollment target sits among peer trials

20 126th of 202 higher than 66 of 202 other Spinal Cord Injuries trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Spinal Cord Injuries 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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Source: ClinicalTrials.gov NCT04047992, the US trial registry maintained by the National Library of Medicine. NCT04047992 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.