---
title: Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury
nct_id: NCT03621254
overall_status: RECRUITING
phase: NA
sponsor: Swiss Paraplegic Research, Nottwil
study_type: INTERVENTIONAL
primary_condition: Spinal Cord Injury
countries: Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03621254.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03621254"
ct_last_update_post_date: 2025-11-26
last_seen_at: "2026-05-12T06:21:00.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

**NCT ID:** [NCT03621254](https://clinicaltrials.gov/study/NCT03621254)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Swiss Paraplegic Research, Nottwil
- **Conditions:** Spinal Cord Injury
- **Start Date:** 2019-01-07
- **Completion Date:** 2026-12
- **CT.gov Last Update:** 2025-11-26

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Greater than 6-weeks post-trauma after SCI.
* Traumatic and atraumatic spinal cord injuries between C7 and T10
* Participants diagnosed with "motor complete' spinal cord injury American Spinal Injury Association Impairment Scale A and B.
* Age between 18-75 years old.
* Both male and female.
* Have at least 90º bilateral knee flexion.
* Able to perform FES muscle contractions (not FES intolerant).
* Able to follow verbal instructions.

Exclusion Criteria:

* A recent history of trauma to the lower limb.
* Severe or infected pressure sore on weight-bearing skin areas.
* Illness caused by acute urinary tract infection.
* Uncontrolled spasticity or pain.
* History of cardiovascular / cardiorespiratory disease contraindicating exercise.
* Uncontrolled orthostatic hypotension.
* Unhealed decubiti at electrode placement area.
* Recurrent and uncontrolled autonomic dysreflexia.
* Active heterotopic ossification.
* Other peripheral or central neurologic injury.
```

## Arms

- **[HI-SHORT]** (EXPERIMENTAL) — High-intensity interval training modality of exercise using FES-evoked leg cycling. Three-four times weekly over 6-8 weeks (24 therapy sessions). The programme is 10 x 2-min exercise intervals with 1-2 min of recovery between intervals. High intensity is achieved by high FES current amplitude (120-150 milliampere, patient dependent)
- **[LO-LONG]** (ACTIVE_COMPARATOR) — Low-moderate intensity continuous training modality of exercise using FES-evoked leg cycling. Three-four times weekly over 6-8 weeks (24 therapy sessions). The programme is 20+ min continuous exercise. Lower intensity is achieved by lower FES current amplitude (\< 90-100 milliampere, patient dependent)

## Interventions

- **[LO-LONG]** (OTHER) — Both interventions are different modalities of FES-evoked leg exercise, three-four times per week for 6-8 weeks (24 therapy sessions). The comparator intervention (\[LO-LONG\]) uses 20-40 min (patient state of fitness dependent) of continuous leg exercise of lower intensity.
- **[HI-SHORT** (OTHER) — One intervention (\[HI-SHORT\]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals.

## Primary Outcomes

- **Aerobic Fitness** _(time frame: Day 0 to 6 weeks)_ — Change of Peak Oxygen Uptake - VO2peak (L/min)

## Secondary Outcomes

- **Muscle Near Infrared Spectroscopy** _(time frame: Day 0 to 6 Weeks)_
- **Strength Fitness** _(time frame: Day 0 to 6 weeks)_

## Locations (1)

- Swiss Paraplegic Centre, Nottwil, Canton of Lucerne, Switzerland — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.swiss paraplegic centre|nottwil|canton of lucerne|switzerland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03621254.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03621254*  
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