このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

24

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • カナダ
    • Ontario
      • Toronto、Ontario、カナダ、M4G 3V9
        • KITE Research Institute, Toronto Rehabilitation Institute-University Health Network
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Kristin E Musselman, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：FES+HIIT@Home
Functional electrical stimulation combined with high intensity interval training at home
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Enrollment rates
時間枠：During enrollment
Number of participants screened per month (plus reasons for exclusion) and the number of participants enrolled per month
During enrollment
Adherence
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University Health Network, Toronto

捜査官

  • 主任研究者：Kristin E Musselman, PhD、University Health Network, Toronto

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2028年7月1日

研究の完了 (推定)

2028年7月1日

試験登録日

最初に提出

2026年8月11日

QC基準を満たした最初の提出物

2026年8月14日

最初の投稿 (実際)

2026年8月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月19日

QC基準を満たした最後の更新が送信されました

2026年8月14日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 26-5324

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有サポート情報タイプ

  • STUDY_PROTOCOL

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する