Functional Electrical Stimulation Plus High Intensity Interval Training at Home
14 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
24
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kristin E Musselman, PhD
- Número de telefone: 6190 416-597-3422
- E-mail: kristin.musselman@utoronto.ca
Estude backup de contato
- Nome: Katherine Chan, MSc
- Número de telefone: 6199 416-597-3422
- E-mail: katherine.chan@uhn.ca
Locais de estudo
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Ontario
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Toronto, Ontario, Canadá, M4G 3V9
- KITE Research Institute, Toronto Rehabilitation Institute-University Health Network
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Contato:
- Kristin E Musselman, PhD
- Número de telefone: 6190 416-597-3422
- E-mail: kristin.musselman@utoronto.ca
-
Contato:
- Katherine Chan, MSc
- Número de telefone: 6199 416-597-3422
- E-mail: katherine.chan@uhn.ca
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Investigador principal:
- Kristin E Musselman, PhD
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Enrollment rates
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: From enrollment until the end of the study at 34 weeks
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Number of minor and serious adverse events
|
From enrollment until the end of the study at 34 weeks
|
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Function for participants unable to stand
Prazo: 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.
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).
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From enrollment until the end of the study at 34 weeks
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Cardiorespiratory fitness
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Kristin E Musselman, PhD, University Health Network, Toronto
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
1 de julho de 2028
Conclusão do estudo (Estimado)
1 de julho de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
11 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de agosto de 2026
Primeira postagem (Real)
19 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-5324
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .