Functional Electrical Stimulation Plus High Intensity Interval Training at Home
2026年8月14日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
24
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kristin E Musselman, PhD
- 电话号码：6190 416-597-3422
- 邮箱：kristin.musselman@utoronto.ca
研究联系人备份
- 姓名：Katherine Chan, MSc
- 电话号码：6199 416-597-3422
- 邮箱：katherine.chan@uhn.ca
学习地点
-
-
Ontario
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Toronto、Ontario、加拿大、M4G 3V9
- KITE Research Institute, Toronto Rehabilitation Institute-University Health Network
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接触：
- Kristin E Musselman, PhD
- 电话号码：6190 416-597-3422
- 邮箱：kristin.musselman@utoronto.ca
-
接触：
- Katherine Chan, MSc
- 电话号码：6199 416-597-3422
- 邮箱：katherine.chan@uhn.ca
-
首席研究员：
- Kristin E Musselman, PhD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：FES+HIIT@Home
Functional electrical stimulation combined with high intensity interval training at home
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Enrollment rates
大体时间：During enrollment
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Number of participants screened per month (plus reasons for exclusion) and the number of participants enrolled per month
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During enrollment
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Adherence
大体时间：From enrollment until the end of the study at 34 weeks
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Session attendance (plus reasons for absences) and assessment attendance (plus reasons for omissions)
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From enrollment until the end of the study at 34 weeks
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Feasibility of FES+HIIT@Home
大体时间：During the FES+HIIT@Home intervention
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Number of sessions in which each participant achieves the targeted "all out" RPE (and HR for those with lower thoracic SCI)
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During the FES+HIIT@Home intervention
|
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Attrition
大体时间：From enrollment until the end of the study at 34 weeks
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Number of participants who drop out of the study and the reasons for drop out
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From enrollment until the end of the study at 34 weeks
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Safety of FES+HIIT@Home
大体时间：From enrollment until the end of the study at 34 weeks
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Number of minor and serious adverse events
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From enrollment until the end of the study at 34 weeks
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Function for participants unable to stand
大体时间：From enrollment to the end of the 12-week follow-up at 34 weeks
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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.
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From enrollment to the end of the 12-week follow-up at 34 weeks
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Function for participants able to stand
大体时间：From enrollment until the end of the study at 34 weeks
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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.
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From enrollment until the end of the study at 34 weeks
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Muscle Strength
大体时间：From enrollment until the end of the study at 34 weeks
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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.
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From enrollment until the end of the study at 34 weeks
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Penn Spasm Frequency Scale
大体时间：From enrollment until the end of the study at 34 weeks
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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.
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From enrollment until the end of the study at 34 weeks
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Spinal Cord Assessment Tool for Spastic Reflexes
大体时间：From enrollment until the end of the study at 34 weeks
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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).
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From enrollment until the end of the study at 34 weeks
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Exercise Self-efficacy Scale
大体时间：From enrollment until the end of the study at 34 weeks
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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).
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From enrollment until the end of the study at 34 weeks
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Cardiorespiratory fitness
大体时间：From enrollment until the end of the study at 34 weeks
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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.
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From enrollment until the end of the study at 34 weeks
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Arterial stiffness
大体时间：From enrollment until the end of the study at 34 weeks
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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.
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From enrollment until the end of the study at 34 weeks
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Description of the contexts that impact outcomes of FES+HIIT@Home
大体时间：After 24 sessions (or 8 weeks) of the FES+HIIT@Home intervention and at the 12-week follow-up at 34 weeks
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To describe the contexts (e.g., virtual setting, group sessions) that impact outcomes from the perspectives of people with SCI
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After 24 sessions (or 8 weeks) of the FES+HIIT@Home intervention and at the 12-week follow-up at 34 weeks
|
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Description of the mechanisms that impact outcomes of FES+HIIT@Home
大体时间：After 24 sessions (or 8 weeks) of the FES+HIIT@Home intervention and at the 12-week follow-up at 34 weeks
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To describe the mechanisms (e.g., FES, HIIT, education) that impact outcomes from the perspectives of people with SCI
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After 24 sessions (or 8 weeks) of the FES+HIIT@Home intervention and at the 12-week follow-up at 34 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kristin E Musselman, PhD、University Health Network, Toronto
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2028年7月1日
研究完成 (估计的)
2028年7月1日
研究注册日期
首次提交
2026年8月11日
首先提交符合 QC 标准的
2026年8月14日
首次发布 (实际的)
2026年8月19日
研究记录更新
最后更新发布 (实际的)
2026年8月19日
上次提交的符合 QC 标准的更新
2026年8月14日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.