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Functional Electrical Stimulation Plus High Intensity Interval Training at Home

14 augusti 2026 uppdaterad av: Kristin Musselman, University Health Network, Toronto

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

24

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M4G 3V9
        • KITE Research Institute, Toronto Rehabilitation Institute-University Health Network
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Kristin E Musselman, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Be ambulatory or use a manual wheelchair.
  6. Be able to don/doff electrodes independently or with support from a family member or other caregiver.
  7. Have physician clearance to participate in high intensity interval training (i.e., no contraindications to HIIT).
  8. Have an emergency contact who can be reached by the research team during FES+HIIT@Home sessions.
  9. Able to understand spoken English.

Exclusion Criteria:

  1. Presents with contraindications to FES (i.e. implanted electronic device, radiation in past six months, active deep vein thrombosis, pregnancy) (Houghton et al. 2010).
  2. Presents with cognitive deficits that would prevent independent use of an FES device.
  3. Has irritated and/or damaged skin in areas where the electrodes will be applied.
  4. Has a cardiovascular morbidity that would limit exercise tolerance, as identified through pre-intervention cardiorespiratory fitness testing (e.g., complex arrhythmias).
  5. 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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: FES+HIIT@Home
Functional electrical stimulation combined with high intensity interval training at home
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Enrollment rates
Tidsram: During enrollment
Number of participants screened per month (plus reasons for exclusion) and the number of participants enrolled per month
During enrollment
Adherence
Tidsram: From enrollment until the end of the study at 34 weeks
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
Tidsram: 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)
During the FES+HIIT@Home intervention
Attrition
Tidsram: 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
From enrollment until the end of the study at 34 weeks
Safety of FES+HIIT@Home
Tidsram: From enrollment until the end of the study at 34 weeks
Number of minor and serious adverse events
From enrollment until the end of the study at 34 weeks
Function for participants unable to stand
Tidsram: 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.
From enrollment to the end of the 12-week follow-up at 34 weeks
Function for participants able to stand
Tidsram: 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.
From enrollment until the end of the study at 34 weeks
Muscle Strength
Tidsram: 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.
From enrollment until the end of the study at 34 weeks
Penn Spasm Frequency Scale
Tidsram: 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.
From enrollment until the end of the study at 34 weeks
Spinal Cord Assessment Tool for Spastic Reflexes
Tidsram: 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).
From enrollment until the end of the study at 34 weeks
Exercise Self-efficacy Scale
Tidsram: 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).
From enrollment until the end of the study at 34 weeks
Cardiorespiratory fitness
Tidsram: 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.
From enrollment until the end of the study at 34 weeks
Arterial stiffness
Tidsram: 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.
From enrollment until the end of the study at 34 weeks
Description of the contexts that impact outcomes of FES+HIIT@Home
Tidsram: 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
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
Tidsram: 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
After 24 sessions (or 8 weeks) of the FES+HIIT@Home intervention and at the 12-week follow-up at 34 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Health Network, Toronto

Utredare

  • Huvudutredare: Kristin E Musselman, PhD, University Health Network, Toronto

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 juli 2028

Avslutad studie (Beräknad)

1 juli 2028

Studieregistreringsdatum

Först inskickad

11 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

14 augusti 2026

Första postat (Faktisk)

19 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 26-5324

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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