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Spinal Cord InjuriesNCT04307017

Fitness Training Using WBEMS Among Individuals With SCI

A study testing StimaWell®EMS in people with Spinal Cord Injuries, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
StimaWell®EMS
How many people
1 participants
Where
1 siteCanada
Study dates
1 Feb 2020to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1) 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
Show all 18Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

    Toronto, Ontario, M4G 3V9

Other trials in Canada

About this study

Official title: Physical Fitness Training Using Whole-Body Electrical Muscle Stimulation Among Individuals Living With Chronic Spinal Cord Injury

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.

Being tested
StimaWell®EMS
Keywords
Physical Fitness, Whole body electrical muscle stimulation
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StimaWell®EMSOther

    The StimaWell®EMS device is a 12-channel medium-frequency device with modulated low frequency using a high-tech stimulation suit for the trunk and strap electrodes for the arms and legs allowing whole-body stimulation. The device has 70 preprogramed training programs based on goals (e.g., strengthening, endurance training, aerobic training).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Training Session

    Time in minutes

    Measured: For the 30 training sessions spread over 10 weeks

  2. Intensity of Training Session

    Type of activity; repetitions; weight resistance

    Measured: For the 30 training sessions spread over 10 weeks

  3. Adverse Events

    All adverse events, even minor, will be reported in the intervention CRF, and compiled in a specific document (Adverse Event Report Form) all along the study to be analyzed as an outcome of the study

    Measured: For the 30 training sessions spread over 10 weeks, if necessary

Secondary outcomes (6)

  1. Weight

    Measured: Up to 10 weeks

  2. Height

    Measured: Up to 10 weeks

  3. Body Mass Index

    Measured: Up to 10 weeks

  4. Anthropometric data

    Circumference of the waist, abdominal region, thighs, legs, arms and forearms

    Measured: Up to 10 weeks

  5. Maximal Isometric Voluntary Strength

    Maximal strength of the major muscle groups of upper extremity (i.e., flexors, extensors and abductors of the shoulder, and flexors and extensors of the elbow) will be measured using hand-held dynamometer

    Measured: Up to 10 weeks

  6. Exercise Self-Efficacy Questionnaire

    Used to assess the perception and confidence to do leisure time physical activity

    Measured: Up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2020
  2. Study start1 Feb 2020
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04307017
Sponsor's protocol ID
19-5246
Status last verified
Mar 2021
First submitted
5 Mar 2020
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing StimaWell®EMS in people with Spinal Cord Injuries, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Training Session (time frame: For the 30 training sessions spread over 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04307017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.

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