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Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Site contact updatedv13
  2. Site contact updatedv12
  3. Re-verified, no change to tracked fieldsv11
  4. Primary completion date: Sep 2024 to Dec 2026
    • Study completion date: Dec 2024 to Dec 2026
    v10
  5. Primary completion date: Jun 2023 to Sep 2024
    • Study completion date: Aug 2023 to Dec 2024
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Primary completion date: Sep 2023 to Jun 2023v7 Show 4 more changesShow less
    • Study completion date: Sep 2023 to Aug 2023
    • Site contact updated
    • Eligibility criteria shortened, about 4 words
    • Study title shortened, about 1 word
  3. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Dec 2021 to Sep 2023
    • Study completion date: Aug 2022 to Sep 2023
    • Site details revised
    v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  5. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Jun 2019 to Dec 2021
    • Study sites: 0 to 1
    • Study completion date: Aug 2019 to Aug 2022
    • Start date changed from estimate of Oct 21, 2018 to Jan 7, 2019
  6. Primary completion date: Apr 2019 to Jun 2019
    • Study completion date: Jun 2019 to Aug 2019
    • Start date: Sep 30, 2018 to Oct 21, 2018
    v3
  7. Start date: Aug 15, 2018 to Sep 30, 2018v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 aim of this study is to investigate two different modalities of functional electrical stimulation (FES) leg exercise in patients with spinal cord injury (SCI). The primary outcomes being compared are 1. FES-induced leg aerobic fitness, and 2. FES-induced leg strength. There will be two FES-leg training groups, and sub-acute patients with SCI will be randomised between the groups - high-short \[HI-SHORT\] and low-long \[LO-LONG\]. Both groups (n=10 per group) will exercise on the Hasomed RehaStim™ exercise ergometer for 6-8 weeks, three-four times per week (24 therapy sessions). \[HI-SHORT\] will perform 10 x 2-min of high-intensity interval training with a recovery of 1-2 min between exercise bouts. \[LO-LONG\] will perform 20+ min of continuous exercise at a low-moderate exercise intensity. Exercise intensity for \[HI-SHORT\] and \[LO-LONG\] will be titrated by neuromuscular stimulation characteristics. The primary outcomes will be assessed before training commences and after 6-8 weeks of training has been completed.
Trial Details
NCT Number NCT03621254
Lead Sponsor Swiss Paraplegic Research, Nottwil
Conditions
(from sponsor)		 Spinal Cord Injury
Related terms Spinal Cord Injuries
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov