Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

NCT03621254 | Recruiting

• 1 other identifier: 2018-11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Functional Electrical Stimulation; Exercise Training; Aerobic Fitness; Muscle Strength

Outcome Measures

Primary Outcomes (1)

• Aerobic Fitness

  Change of Peak Oxygen Uptake - VO2peak (L/min)

  Day 0 to 6 weeks

Secondary Outcomes (2)

• Muscle Near Infrared Spectroscopy

  Day 0 to 6 Weeks

• Strength Fitness

  Day 0 to 6 weeks

Other Outcomes (2)

• Muscle Volume

  Day 0 to 6 weeks

• Muscle Fatigue

  Day 0 to 6 weeks

Study Arms (2)

[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)

Other: [HI-SHORT

[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)

Other: [LO-LONG]

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.

[LO-LONG]

[HI-SHORT OTHER

One intervention (\[HI-SHORT\]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals.

[HI-SHORT]

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Glen M Davis, Prof. Dr.

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ines Bersch, PhD

CONTACT

+41 41 939 42 06; ines.bersch@paraplegie.ch

Kathrin Schafer, MPH

CONTACT

+41 41 939 43 34; kathrin.schafer@paraplegie.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomised Controlled Design

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 8, 2018
• Study Start: January 7, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)