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Seated Balance Using the Indego™

StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

  1. Notable Primary completion date: Sep 30, 2024 to Sep 30, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v3
  2. Notable Primary completion date: Sep 30, 2020 to Sep 30, 2024
    • Study completion date: Dec 31, 2020 to Dec 31, 2024
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04047992
Lead Sponsor James J. Peters Veterans Affairs Medical Center
Conditions
(from sponsor)
Spinal Cord Injuries
Related terms Spinal Cord Injuries
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov