Clinical Trial

Seated Balance Using the Indego™

Recruiting
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Record status
This record was last updated May 14, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2019-08-05; most recent amendment 2025-05-09.
Trial Details
NCT Number NCT04047992
Lead Sponsor James J. Peters Veterans Affairs Medical Center
Conditions Spinal Cord Injuries
Enrollment 20 participants
Start Date 2018-02-01
Primary Completion 2025-09-30 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-14