An interventional study of FES+HIIT@Home in Spinal Cord Injuries (SCI), sponsored by University Health Network, Toronto. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Other
Among 21 studies in Spinal Cord Injuries by University Health Network, Toronto — 7 open to participants now, 7 under way, none of them phase 3. Spinal Cord Injuries · University Health Network, Toronto.
Among the 21 studies in Spinal Cord Injuries by University Health Network, Toronto, this one is the 3rd largest by planned enrollment of the 19 interventional ones that give a count, is the only one that started in 2027, is one of 18 with no phase, and was the 21st registered.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
Browse Spinal Cord Injuries studies →7 of the 21 studies in Spinal Cord Injuries by University Health Network, Toronto are open now, in 1 country. Recruiting first, the newest first:
University Health Network, Toronto · Sites in Canada
Ages 18–65
University Health Network, Toronto · Sites in Canada
Ages 18+
University Health Network, Toronto · Sites in Canada
Ages 18+
University Health Network, Toronto · Sites in Canada
Ages 18+
University Health Network, Toronto · Sites in Canada
Ages 18+
By country, each count listing its studies:
Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 1 started in 2027.
This study's planned enrollment of 24 is close to the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Median enrollment 18 across the 19 interventional studies, 35 across the 2 observational. Of the 13 that completed or were terminated, 1 (8%) have results posted.
This tab as a report to print or save as PDF → With an account.
University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
1 of the studies in Spinal Cord Injuries by University Health Network, Toronto that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06472986University Health Network, TorontoActivity-Based Therapy and Transcutaneous Spinal Cord Stimulation After Spinal Cord Injury (ABT-TCSCS) | 2026-12-31 |
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Among the 21 studies in Spinal Cord Injuries by University Health Network, Toronto, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Functional electrical stimulation combined with high intensity interval training at home
Other: FES+HIIT@Home
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.
Enrollment rates
Number of participants screened per month (plus reasons for exclusion) and the number of participants enrolled per month
Time frame: During enrollment
Adherence
Session attendance (plus reasons for absences) and assessment attendance (plus reasons for omissions)
Time frame: 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)
Time frame: During the FES+HIIT@Home intervention
Attrition
Number of participants who drop out of the study and the reasons for drop out
Time frame: From enrollment until the end of the study at 34 weeks
Safety of FES+HIIT@Home
Number of minor and serious adverse events
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: After 24 sessions (or 8 weeks) of the FES+HIIT@Home intervention and at the 12-week follow-up at 34 weeks
Plan to share: Yes — The de-identified, quantitative datasets will be shared through the Open Data Commons for Spinal Cord Injury (odc-sci.org) and supplementary files will be made available in the publications.
Supporting information: Study protocol
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jul 2028, 18 months later.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 18 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Jan 2027, on Oct 26, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto →