Seated Balance Using the Indego™

Part of paid clinical trials in The Bronx, New York.

Sponsor
James J. Peters Veterans Affairs Medical Center
Study ID
NCT04047992
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Indego™ Exoskeleton — DEVICE
    The Indego® is a powered exoskeleton that can be used as a mode of therapy in an institutional setting. Proper walking in this device requires the user to manipulate their center of gravity and balance by postural trunk excursions in order for the legs to take steps.

Study Details

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.

Key Dates

Start date
Feb 1, 2018
Status verified
May 2025
Primary completion
Sep 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Exoskeleton Users
    All participants will receive 36 sessions of supervised EAW training using Indego™ for 12 weeks (3 to 4 sessions per week, 4-6 hours per week). The goal is to complete all 36 sessions in 12 weeks, but allowing for a two-week carryover to accommodate schedule conflicts or missed sessions.

Primary Outcome Measure

Seated Computerized Dynamic Posturography (sCDP) [ Time Frame: Change from baseline after 8 weeks and after 12 weeks. ]

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters VA Medical CenterThe BronxNew York10468
Steven Knezevic, MS
[email protected]
718-584-9000
Pierre K Asselin, MS
[email protected]
718-584-9000
Annn M Spungen, EdD (PRINCIPAL_INVESTIGATOR)

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By research site
James J. Peters VA Medical Center· The Bronx, NY

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