Tele-CE in Severe Stroke
2026年6月11日 更新者：Sangeetha Madhavan、University of Illinois at Chicago
Effect of Home-based Cross-education on Lower Limb Neuroplasticity in Severe Stroke
The goal of this clinical trial is to determine the effects of home-based cross-education on lower limb neuroplasticity in severe stroke.
The main questions the investigators aim to answer are:
- What are the effects of home-based cross-education on lower limb neuroplasticity?
- What are the effects of home-based cross-education on lower limb function?
- Is home-based cross-education feasible to administer and accepted by participants?
Participants will take part in ten home-based, remotely supervised sessions, during which participants will either perform unilateral skill and strength training of the unaffected lower limb (Tele-Cross Education or Tele-CE) or cognitive training and unilateral movements of the unaffected lower limb (Tele-control). Each participant will experience measures of brain and spinal activity and motor function testing before and after both sessions (Tele-CE and Tele-control). Each participant will also be asked to fill out a feedback questionnaire to assess acceptability after intervention sessions (Tele-CE and Tele-control).
調査の概要
研究の種類
介入
入学 (推定)
40
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。
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60612
- 募集
- Brain Plasticity Lab
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コンタクト：
- Shravni Deshmukh
- 電話番号：312-996-9056
- メール：sdeshm20@uic.edu
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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:
- Single, monohemispheric stroke
- Chronic stroke (> 6 months prior)
- Severe stroke (Fugl-Meyer Lower Extremity motor scale score < 21 or 6 Minute Walk Test distance < 300m)
Exclusion Criteria:
- Use of anti-spasticity medications
- Existence of other neurological disorders
- Have brainstem or cerebellar lesions.
- Mini-Mental State Examiniation score of <21, to ensure participants have the cognitive capacity to consent and can understand instructions both in-person and during remote supervision.
- Non-English-speaking individuals
- Bone, joint or soft tissue injury
- Uncontrolled medical conditions (such as uncontrolled hypertension, untreated cardiac disease, or untreated pulmonary disease)
- Unable to see the tablet and zoom screen
- Unable to move non-paretic ankle (< 5 degrees of ankle ROM)
- Fugl-Meyer Lower Extremity sensory scale score < 6
TMS exclusion criteria
- Previous adverse reaction to TMS
- Skull abnormalities or fractures
- Concussion within the prior 6 months
- Unexplained, recurring headaches
- Implanted cardiac pacemaker
- Metal implants in the head or face
- History of seizures or epilepsy
- Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants)
- Current pregnancy
PNS exclusion criteria
- Skin hypersensitivity at any sites of stimulation, including the scalp, thoracolumbar spine, and peripheral limbs
- History of contact dermatitis at any of the sites of stimulation
- History of allodynia and/or hyperalgesia
- Active skin infection
- Skin lesions
- Deep vein thrombosis
- Any other skin or scalp condition that could be aggravated by stimulation
- Implanted electronic, metallic, or highly conductive devices near site of stimulation that cannot be removed without permission from a health professional
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Tele-Cross Education (Tele-CE)
While seated, participants will begin with 15 minutes of game-based ankle skill training of the unaffected lower limb.
Participants will perform skilled dorsiflexion and plantarflexion movements of the unaffected ankle to play simple and engaging games.
Three game blocks will be played (5 mins/block) with 1-minute rest between blocks.
Following this, participants will engage in unaffected leg strength training using a theraband targeting hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors.
Participants will perform 3 sets of 10 repetitions for each muscle group.
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Skilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games.
Unilateral lower limb strength training of the unaffected leg using a theraband targeting hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors.
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偽コンパレータ：Tele-Control
While seated, participants will begin with 15 minutes of cognitive training using games focusing on memory and executive function.
Participants will play three cognitive games (5 minutes each with 1-min rest between blocks).
Following this, participants will engage in unilateral leg movements of the unaffected hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors.
Participants will perform 3 sets of 10 repetitions of movements for each muscle group.
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Cognitive training using games focusing on memory and executive function along with unilateral leg movements of the unaffected hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors.
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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 |
|---|---|---|
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Corticomotor excitability using transcranial magnetic stimulation (TMS)
時間枠：Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Single-pulse transcranial magnetic stimulation (TMS) will be used to assess the corticomotor excitability from the tibialis anterior muscle.
Higher values indicate more corticomotor excitability.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Transcallosal Inhibition using transcranial magnetic stimulation (TMS)
時間枠：Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Inhibition from the stimulated hemisphere to the non-stimulated hemisphere will be quantified as a measure of the ipsilateral silent period (iSP) using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the leg ipsilateral to TMS stimulation.
Higher values indicate more inhibition from the stimulated hemisphere to the non-stimulated hemisphere.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
|
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Cutaneous reflex excitability using peripheral nerve stimulation (PNS)
時間枠：Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Peripheral nerve stimulation (PNS) will be used to assess the cutaneous reflexes excitability from the deep peroneal nerve.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Muscle Strength
時間枠：Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Muscle strength of the affected and unaffected hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors will be measured using handheld dynamometry.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Walking speed
時間枠：Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Participants will complete the 10-Meter Walk Test (10MWT) on a flat, unobstructed walkway to measure walking speed.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Walking endurance
時間枠：Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Participants will perform 6-minute walk test (6MWT) to measure endurance.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Physical activity levels
時間枠：Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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The investigators will use an activity monitor to measure daily step count and moderate to vigorous physical activity percent.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Intervention acceptability
時間枠：Feedback will be collected immediately after the intervention (post).
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Acceptability will be assessed through one custom semi-structured patient feedback questionnaire that includes domains of perceived satisfaction.
Higher values indicate higher participant acceptability and perceived satisfaction of the intervention.
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Feedback will be collected immediately after the intervention (post).
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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。
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6月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年6月8日
QC基準を満たした最初の提出物
2026年6月11日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月11日
最終確認日
2026年6月1日
詳しくは
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。