search
Back to results

Fitness Training Using WBEMS Among Individuals With SCI

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
StimaWell®EMS
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries focused on measuring Physical Fitness, Whole body electrical muscle stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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;
  2. be at least one year post-injury (i.e., chronic injury);
  3. be between 18 and 65 years of age;
  4. be cleared for physical activity based on The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)34
  5. be able to provide informed, written consent.

Exclusion Criteria:

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
  • 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)

Sites / Locations

  • Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

Outcomes

Primary Outcome Measures

Duration of Training Session
Time in minutes
Intensity of Training Session
Type of activity; repetitions; weight resistance
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

Secondary Outcome Measures

Weight
Height
Body Mass Index
Anthropometric data
Circumference of the waist, abdominal region, thighs, legs, arms and forearms
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
Exercise Self-Efficacy Questionnaire
Used to assess the perception and confidence to do leisure time physical activity

Full Information

First Posted
March 5, 2020
Last Updated
March 30, 2021
Sponsor
University Health Network, Toronto
Collaborators
Université de Montréal
search

1. Study Identification

Unique Protocol Identification Number
NCT04307017
Brief Title
Fitness Training Using WBEMS Among Individuals With SCI
Official Title
Physical Fitness Training Using Whole-Body Electrical Muscle Stimulation Among Individuals Living With Chronic Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Université de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Physical Fitness, Whole body electrical muscle stimulation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
StimaWell®EMS
Intervention Description
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).
Primary Outcome Measure Information:
Title
Duration of Training Session
Description
Time in minutes
Time Frame
For the 30 training sessions spread over 10 weeks
Title
Intensity of Training Session
Description
Type of activity; repetitions; weight resistance
Time Frame
For the 30 training sessions spread over 10 weeks
Title
Adverse Events
Description
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
Time Frame
For the 30 training sessions spread over 10 weeks, if necessary
Secondary Outcome Measure Information:
Title
Weight
Time Frame
Up to 10 weeks
Title
Height
Time Frame
Up to 10 weeks
Title
Body Mass Index
Time Frame
Up to 10 weeks
Title
Anthropometric data
Description
Circumference of the waist, abdominal region, thighs, legs, arms and forearms
Time Frame
Up to 10 weeks
Title
Maximal Isometric Voluntary Strength
Description
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
Time Frame
Up to 10 weeks
Title
Exercise Self-Efficacy Questionnaire
Description
Used to assess the perception and confidence to do leisure time physical activity
Time Frame
Up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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)
Facility Information:
Facility Name
Lyndhurst Centre, Toronto Rehabilitation Institute-UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3V9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Fitness Training Using WBEMS Among Individuals With SCI

We'll reach out to this number within 24 hrs