Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

NCT ID: NCT03621254

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[HI-SHORT]

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)

Group Type: EXPERIMENTAL

[HI-SHORT

Intervention Type: OTHER

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

[LO-LONG]

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)

Group Type: ACTIVE_COMPARATOR

[LO-LONG]

Intervention Type: 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.

Interventions

[LO-LONG]

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.

Intervention Type: OTHER

[HI-SHORT

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glen M Davis, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Ines Bersch, PhD

Role: CONTACT

Phone: +41 41 939 42 06

Email: ines.bersch@paraplegie.ch

Kathrin Schafer, MPH

Role: CONTACT

Phone: +41 41 939 43 34

Email: kathrin.schafer@paraplegie.ch

Facility Contacts

Ines Bersch, PhD

Role: primary

Kathrin Schafer, MPH

Role: backup

Ines Bersch, PhD

Role: backup

Other Identifiers

2018-11

Identifier Type: -

Identifier Source: org_study_id