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Evaluation of an Advanced Lower Extremity Neuroprostheses

Study acronym: LE-IST
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv22
  2. Primary and study completion dates: May 31, 2025 to Dec 31, 2027
    • Eligibility criteria expanded, about 30 words
    • Site contacts updated at 1 of 2 sites
    • Publications: details revised at 2 of 8 entries
    v21
  3. Interventions: IST-16 (16-channel implanted stimulator-telemeter) (Device) to IST (Implanted Stimulator-Telemeter) (Device)
    • Site contacts updated at 1 of 2 sites
    • Collaborators shortened, about 10 words
    • Publications: details revised at 2 of 8 entries
    v20
  4. Primary endpoints revised (4)v19
  5. Site contacts updated at 2 of 2 sitesv18
Show 16 earlier versionsHide 16 earlier versions
  1. 2 versions Re-verified since Sep 15, 2022, no change to tracked fieldsv16-v17
  2. Primary endpoints: 1 to 4
    • Secondary endpoint revised
    v15
  3. Primary completion date: Jan 2021 to May 31, 2025
    • Start date: May 2005 to Jun 1, 2018
    • Study completion date: Jun 2021 to May 31, 2025
    v14
  4. Site contacts updated at 1 of 2 sitesv13
  5. Primary completion date: Jan 2019 to Jan 2021
    • Study completion date: Jun 2019 to Jun 2021
    • Collaborators revised (2)
    v12
  6. Site contacts updated at 2 of 2 sitesv11
  7. Primary completion date: Jan 2017 to Jan 2019
    • Study completion date: Jun 2017 to Jun 2019
    v10
  8. Collaborators revised (2)v9
  9. Primary completion date: Jan 2015 to Jan 2017
    • Study completion date: Jun 2015 to Jun 2017
    • Site contacts updated at 2 of 2 sites
    v8
  10. Site contacts updated at 2 of 2 sitesv7
  11. Enrollment target: 25 to 10
    • Site contacts updated at 2 of 2 sites
    v6
  12. Re-verified, no change to tracked fieldsv5
  13. Primary completion date: Jan 2011 to Jan 2015
    • Site contacts updated at 2 of 2 sites
    v4
  14. Re-verified, no change to tracked fieldsv3
  15. Study sites: 1 to 2
    • Interventions: IST-16 (Device) to IST-16 (16-channel implanted stimulator-telemeter) (Device)
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.
Trial Details
NCT Number NCT00623389
Lead Sponsor Case Western Reserve University
Conditions
(from sponsor)		 Spinal Cord Injuries, Stroke, Paralysis, Tetraplegia, Paraplegia
Related terms Nervous System Diseases, Paralysis, Paraplegia, Quadriplegia, Rare Diseases, Spinal Cord Injuries, Stroke
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov