Clinical Trial

Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

Recruiting
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Summary
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2018-08-03; most recent amendment 2025-11-20.
Status change: Active, Not Recruiting → Recruiting 2021-05-14
Status change: Recruiting → Active, Not Recruiting 2020-03-30
Status change: Not Yet Recruiting → Recruiting 2019-01-17
Trial Details
NCT Number NCT03621254
Lead Sponsor Swiss Paraplegic Research, Nottwil
Conditions Spinal Cord Injury
Enrollment 20 participants
Start Date 2019-01-07
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-26