Fitness Training Using WBEMS Among Individuals With SCI

University Health Network, Toronto

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Other: StimaWell®EMS

Study type

Interventional

Funder types

Other

Identifiers

NCT04307017

19-5246

Details and patient eligibility

About

Up to 15 individuals living with chronic SCI will be recruited for this study. Each participant will complete an initial clinical assessment before starting a 10-week training program. The training program will consist of three 45-minute Whole-Body Electrical Muscle Stimulation (WBEMS)-augmented exercise training sessions for 10 weeks. At each training session, all adverse events (pain, redness, injury, etc.) will be recorded along with participants' comments concerning comfort (i.e. Objective 1). The investigators hypothesize that the use of a WBEMS will result in no serious adverse effect during and following the training sessions and that it will take less than 10 minutes to don and doff the suit.

At the fifth session, after participants have had the opportunity to become familiar with the WBEMS intervention, the immediate effects of the intervention on physiological responses will be assessed (i.e. Objective 2). It is hypothesized that during a single training session consisting of WBEMS and exercise, physiological responses and energy expenditure (EE) will be significantly improved in participants with SCI compared to a training session consisting solely of exercises without WBEMS.

At the end of the training program, participants will complete the final clinical assessment to evaluate the therapeutic benefit of the WBEMS-augmented exercise intervention (i.e. Objective 3). Three months after the end of the training program, the participants will be asked to complete a semi-structured interview and questionnaire to evaluate the perceived benefits of the training program (i.e. Objective 3).It is also hypothesized that participants will perceive benefits of the 10-week training program such as decreased spasticity, increased energy and improved mood.

Enrollment

1 patient

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

have a motor complete SCI (i.e., American Spinal Injury Association Impairment Scale grade A or B which means complete motor paralysis below the level of injury) at the neurological level T7 or below (i.e., to avoid triggering autonomic dysreflexia). The participants will have complete motor function of their arms but not of their legs;
be at least one year post-injury (i.e., chronic injury);
be between 18 and 65 years of age;
be cleared for physical activity based on The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)34
be able to provide informed, written consent.

Exclusion criteria

Contraindications for EMS35,36. Electrical stimulation should not be applied:

if implanted electronic devices, including cardiac pacemakers
if coronary stents are present
if cosmetics and other implants are present in the application region
to pregnant women
on the regions of known or suspected malignancy
if active deep vein thrombosis or thrombophlebitis
to actively bleeding tissue or to persons with untreated hemorrhagic disorders
to infected tissues, tuberculosis, or wounds with underlying osteomyelitis
if inflammation is present in the region of application
to recently radiated tissues
to the chest in persons with cardiac disease, arrhythmias, or heart failure
to the neck or head region of persons known to have seizures
transcranially without specialized training
to areas near reproductive organs or genitalia without specialized training
to areas near or over eyes
to anterior neck or carotid sinus
to damaged or at-risk skin areas that would result in uneven conduction of current (excluding open wounds where the specific intent is to use electrical stimulation for tissue healing)