Functional Electrical Stimulation Plus High Intensity Interval Training at Home

NCT07773974 | Not Yet Recruiting

• 1 other identifier: 26-5324
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries (SCI)

Keywords

functional electrical stimulation; high intensity interval training; home-based rehabilitation

Outcome Measures

Primary Outcomes (15)

• Enrollment rates

  Number of participants screened per month (plus reasons for exclusion) and the number of participants enrolled per month

  During enrollment

• Adherence

  Session attendance (plus reasons for absences) and assessment attendance (plus reasons for omissions)

  From enrollment until the end of the study at 34 weeks

• Feasibility of FES+HIIT@Home

  Number of sessions in which each participant achieves the targeted "all out" RPE (and HR for those with lower thoracic SCI)

  During the FES+HIIT@Home intervention

• Attrition

  Number of participants who drop out of the study and the reasons for drop out

  From enrollment until the end of the study at 34 weeks

• Safety of FES+HIIT@Home

  Number of minor and serious adverse events

  From enrollment until the end of the study at 34 weeks

• Function for participants unable to stand

  Function will be assessed with the Function in Sitting Test (FIST-SCI) for participants unable to stand. The FIST-SCI assesses postural control during functional sitting activities. Items are rated on the amount of assistance required to accomplish each task on a 5-point scale of 0 (complete assistance - patient cannot perform the task at all) to 4 (independent - patient completely autonomous in performing the task). Scores can be summed for a total score ranging from 0 to 56.

  From enrollment to the end of the 12-week follow-up at 34 weeks

• Function for participants able to stand

  Function will be assessed with the mini-Balance Evaluation Systems Test (mini-BESTest) for participants who are able to stand. The mini-BESTest assesses a variety of functional activities in standing and walking. The Mini BESTest is scored on a 3-level ordinal scale (0 to 2). Scores can be summed for a total score between 0 and 28.

  From enrollment until the end of the study at 34 weeks

• Muscle Strength

  Isometric strength of the trunk, upper limb and lower limb muscles will be evaluated with manual muscle testing (MMT) and/or hand-held dynamometry. Testing positions will be standardized, following guidelines of the ISNCSCI, as appropriate, and strength scored on a 0 to 5 scale. Muscles with a MMT score of ≥4 will also be assessed with hand-held dynamometry, which is a valid assessment method that has greater sensitivity to detect changes in the strength of stronger muscles. Three peak force values will be collected per muscle group and the mean value normalized by body weight.

  From enrollment until the end of the study at 34 weeks

• Penn Spasm Frequency Scale

  The Penn Spasm Frequency Scale is a valid and reliable self-report measure that evaluates an individual's perception of spasticity frequency (on a 5-point scale from 0 (no spasms) to 4 (spontaneous spasms occurring ≥10 times/hour)) and severity (on a 3-point scale from 1 (mild) to 3 (severe)). A spasm severity rating will not be provided if spasm frequency is 0.

  From enrollment until the end of the study at 34 weeks

• Spinal Cord Assessment Tool for Spastic Reflexes

  The Spinal Cord Assessment Tool for Spastic Reflexes is a short clinical exam of three spastic motor behaviors in the lower limb of individuals with SCI: clonus, flexor spasms and extensor spasms. The reactions observed for each motor behavior will be rated on a 4-point ordinal scale and summed for a total score (/9).

  From enrollment until the end of the study at 34 weeks

• Exercise Self-efficacy Scale

  Exercise self-efficacy will be assessed with the SCI Exercise Self-efficacy Scale, which assesses confidence in performing exercise. Participants will rate their confidence, on a scale from 1 (not always true) to 4 (always true), for ten statements related to carrying out regular exercise and physical activity. Reponses are summed for a total score (/40).

  From enrollment until the end of the study at 34 weeks

• Cardiorespiratory fitness

  VO2peak (mL/kg/min), will be evaluated with a maximal graded exercise test. Breath-by-breath gas samples will be collected and averaged over 20 seconds via a calibrated metabolic cart to determine V̇O2peak.

  From enrollment until the end of the study at 34 weeks

• Arterial stiffness

  Pulse wave velocity (PWV, m/s) will be obtained between the common carotid and common femoral arteries (cfPWV). cfPWV (m/sec) will be calculated using the equation: (0.8 × D)÷Δt, where D is the distance between measurement sites and Δt is the pulse transit time.

  From enrollment until the end of the study at 34 weeks

• Description of the contexts that impact outcomes of FES+HIIT@Home

  To describe the contexts (e.g., virtual setting, group sessions) that impact outcomes from the perspectives of people with SCI

  After 24 sessions (or 8 weeks) of the FES+HIIT@Home intervention and at the 12-week follow-up at 34 weeks

• Description of the mechanisms that impact outcomes of FES+HIIT@Home

  To describe the mechanisms (e.g., FES, HIIT, education) that impact outcomes from the perspectives of people with SCI

  After 24 sessions (or 8 weeks) of the FES+HIIT@Home intervention and at the 12-week follow-up at 34 weeks

Study Arms (1)

FES+HIIT@Home

EXPERIMENTAL

Functional electrical stimulation combined with high intensity interval training at home

Other: FES+HIIT@Home

Interventions

FES+HIIT@Home OTHER

The FES+HIIT@Home intervention will be 16 weeks in duration. During the first four weeks of the FES+HIIT@Home intervention (i.e., weeks 3-6), participants and caregivers who will be assisting will receive education and hands-on training with FES and HIIT exercises. Each participant will receive a two-channel FES device to keep (i.e., Chattanooga® Continuum). During weeks 7-18, participants will complete 36 online, group-based FES+HIIT@Home sessions (i.e., three 1-hour sessions/week for 12 weeks) that are led by trainers over Microsoft Teams. Sessions will include warm-up exercises (10 minutes), three task-specific exercises (15 minutes/exercise) and cool-down exercises (5 minutes). Each task-specific exercise will be performed in 30-second "all out" bouts with a 1.5-minute rest after each bout.

FES+HIIT@Home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be an adult (i.e., ≥18 years old) with a SCI at T12 or above as individuals with a lower motor neuron condition are considered poor candidates for FES.
• Have a SCI rated as American Spinal Injury Association Impairment Scale A, B, C or D. If no recent (i.e., in past six months) AIS rating is available in the medical record, the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam (Rupp et al. 2021) will be completed by the research team.
• Be \>1 year post-injury, in the case of traumatic SCI, or \>1 year post-onset of neurological symptoms, in the case of a non-progressive, non-traumatic cause of SCI.
• Be able to attend 8 assessment sessions and three education sessions at the Lyndhurst Centre or Rumsey Cardiac Rehab, as well as 36 FES+HIIT@Home sessions and one education session on Microsoft Teams.
• Be ambulatory or use a manual wheelchair.
• Be able to don/doff electrodes independently or with support from a family member or other caregiver.
• Have physician clearance to participate in high intensity interval training (i.e., no contraindications to HIIT).
• Have an emergency contact who can be reached by the research team during FES+HIIT@Home sessions.
• Able to understand spoken English.

You may not qualify if:

• Presents with contraindications to FES (i.e. implanted electronic device, radiation in past six months, active deep vein thrombosis, pregnancy) (Houghton et al. 2010).
• Presents with cognitive deficits that would prevent independent use of an FES device.
• Has irritated and/or damaged skin in areas where the electrodes will be applied.
• Has a cardiovascular morbidity that would limit exercise tolerance, as identified through pre-intervention cardiorespiratory fitness testing (e.g., complex arrhythmias).
• Participant receives a Botox injection or begins a new therapy or exercise program during the first 20 weeks of the study (i.e., prior to the post-intervention assessments).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

KITE Research Institute, Toronto Rehabilitation Institute-University Health Network

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kristin E Musselman, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin E Musselman, PhD

CONTACT

416-597-3422; kristin.musselman@utoronto.ca

Katherine Chan, MSc

CONTACT

416-597-3422; katherine.chan@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CA (1)