Functional Electrical Stimulation + HIIT for Paralysis

KE
KC
Overseen ByKatherine Chan, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

People living with SCI may experience loss of sensation, movement and regular body function. One way to address these impairments is activity-based therapy (ABT), which includes movement-based activities that promote the muscle-brain connection below the level of injury. A technology often used during ABT is functional electrical stimulation (FES), which is an electrical stimulus applied to nerves or paralyzed muscles through sticky gel pads placed on the skin. The purpose of this multi-method pilot study is to look at the safety, interest in and acceptance of an at-home, virtual training program that combines FES with high intensity interval training (HIIT). Up to 24 individuals with SCI will be enrolled in the study. The study activities will span over 34 weeks, from pre-training tests to the 12-week follow-up tests.

Who Is on the Research Team?

KE

Kristin E Musselman, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults with spinal cord injury (SCI) who have paralysis or loss of function in the chest area. Participants should be able to safely take part in home-based exercise and follow instructions for virtual training.

Inclusion Criteria

I can walk or use a manual wheelchair.
Have a SCI rated as American Spinal Injury Association Impairment Scale A, B, C or D or complete ISNCSCI exam if no recent AIS rating available
Able to understand spoken English
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Exclusion Criteria

Contraindications to FES including implanted electronic device, radiation in past six months, active deep vein thrombosis, pregnancy
My heart condition limits my ability to exercise.
My skin is healthy where electrodes will be placed.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-training

Pre-training tests conducted to establish baseline measurements

2 weeks

Treatment

Participants undergo FES combined with high intensity interval training at home

8 weeks
24 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Functional Electrical Stimulation Plus High Intensity Interval Training at Home

Trial Overview

The study tests a home program that combines functional electrical stimulation (FES)—using mild electrical currents on muscles—with high intensity interval training (HIIT). The goal is to see if this approach is safe, practical, and accepted by people with SCI.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: FES+HIIT@HomeExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+