NCT Number: NCT07773974
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M4G 3V9, Canada
Katherine Chan, MSc
CONTACT
416-597-3422 ext. 6199
Kristin E Musselman, PhD
CONTACT
416-597-3422 ext. 6190
Kristin E Musselman, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: During enrollment
Number of participants screened per month (plus reasons for exclusion) and the number of participants enrolled per month
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)
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)
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
Time frame: From enrollment until the end of the study at 34 weeks
Number of minor and serious adverse events
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.
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.
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.
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.
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).
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).
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.
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.
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
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
Contact information is provided by the study sponsor or research team.
Katherine Chan, MSc
CONTACT
416-597-3422 ext. 6199
Kristin E Musselman, PhD
CONTACT
416-597-3422 ext. 6190
University Health Network, Toronto
Other
Combining Functional Electrical Stimulation With High Intensity Interval Training at Home
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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