Spinal Cord Injuries (SCI)NCT07773974
Functional Electrical Stimulation Plus High Intensity Interval Training at Home
A study testing FES+HIIT@Home in people with Spinal Cord Injuries (SCI), run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- FES+HIIT@Home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2027to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
KITE Research Institute, Toronto Rehabilitation Institute-University Health Network
Toronto, Ontario, M4G 3V9
Kristin E Musselman, PhD, 416-597-3422 ext. 6190, kristin.musselman@utoronto.ca
Katherine Chan, MSc, 416-597-3422 ext. 6199, katherine.chan@uhn.ca
About this study
Official title: Combining Functional Electrical Stimulation With High Intensity Interval Training at Home
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)
- Being tested
- FES+HIIT@Home
- Keywords
- functional electrical stimulation, high intensity interval training, home-based rehabilitation
- 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.
FES+HIIT@HomeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FES+HIIT@Home | Experimental | Functional electrical stimulation combined with high intensity interval training at home Receives: Other: FES+HIIT@Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rates
Number of participants screened per month (plus reasons for exclusion) and the number of participants enrolled per month
Measured: During enrollment
Adherence
Session attendance (plus reasons for absences) and assessment attendance (plus reasons for omissions)
Measured: 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)
Measured: During the FES+HIIT@Home intervention
Attrition
Number of participants who drop out of the study and the reasons for drop out
Measured: From enrollment until the end of the study at 34 weeks
Safety of FES+HIIT@Home
Number of minor and serious adverse events
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: After 24 sessions (or 8 weeks) of the FES+HIIT@Home intervention and at the 12-week follow-up at 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start2 Jan 2027 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Musselman, University Health Network, Toronto
- Investigators
- Kristin E Musselman, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773974
- Sponsor's protocol ID
- 26-5324
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Functional Electrical Stimulation With High Intensity Interval Training at Home
- ClinicalTrials.gov ID
- NCT07773974
- Acronym / sponsor ID
- 26-5324
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- functional electrical stimulation, high intensity interval training, home-based rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 2 Jan 2027 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES+HIIT@Home | Experimental | Other: FES+HIIT@HomeFunctional electrical stimulation combined with high intensity interval training at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FES+HIIT@HomeThe 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. | Other | FES+HIIT@Home |
Primary outcome
Enrollment rates
Time frame: During enrollment
Number of participants screened per month (plus reasons for exclusion) and the number of participants enrolled per month
Adherence
Time frame: From enrollment until the end of the study at 34 weeks
Session attendance (plus reasons for absences) and assessment attendance (plus reasons for omissions)
Feasibility of FES+HIIT@Home
Time frame: During the FES+HIIT@Home intervention
Number of sessions in which each participant achieves the targeted "all out" RPE (and HR for those with lower thoracic SCI)
Attrition
Time frame: From enrollment until the end of the study at 34 weeks
Number of participants who drop out of the study and the reasons for drop out
Safety of FES+HIIT@Home
Time frame: From enrollment until the end of the study at 34 weeks
Number of minor and serious adverse events
Function for participants unable to stand
Time frame: From enrollment to the end of the 12-week follow-up at 34 weeks
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.
Function for participants able to stand
Time frame: From enrollment until the end of the study at 34 weeks
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.
Muscle Strength
Time frame: From enrollment until the end of the study at 34 weeks
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.
Penn Spasm Frequency Scale
Time frame: From enrollment until the end of the study at 34 weeks
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.
Spinal Cord Assessment Tool for Spastic Reflexes
Time frame: From enrollment until the end of the study at 34 weeks
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).
Exercise Self-efficacy Scale
Time frame: From enrollment until the end of the study at 34 weeks
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).
Cardiorespiratory fitness
Time frame: From enrollment until the end of the study at 34 weeks
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.
Arterial stiffness
Time frame: From enrollment until the end of the study at 34 weeks
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.
Description of the contexts that impact outcomes of FES+HIIT@Home
Time frame: After 24 sessions (or 8 weeks) of the FES+HIIT@Home intervention and at the 12-week follow-up at 34 weeks
To describe the contexts (e.g., virtual setting, group sessions) that impact outcomes from the perspectives of people with SCI
Description of the mechanisms that impact outcomes of FES+HIIT@Home
Time frame: After 24 sessions (or 8 weeks) of the FES+HIIT@Home intervention and at the 12-week follow-up at 34 weeks
To describe the mechanisms (e.g., FES, HIIT, education) that impact outcomes from the perspectives of people with SCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin E Musselman, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES+HIIT@Home in people with Spinal Cord Injuries (SCI), 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 9 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin E Musselman, PhD (416-597-3422 ext. 6190, kristin.musselman@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rates (time frame: During enrollment). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.