Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD
2026年7月8日 更新者：Farahnaz Fallahtafti、University of Nebraska
1) Purpose: To improve pulmonary rehabilitation outcomes for individuals with COPD by evaluating the effectiveness of a hip-assisted exoskeleton during a single pulmonary rehabilitation session.
2) Eligibility criteria: Participants must be between 45-75 years old, any gender, but must have a BMI of less than 35 kg/m^2, free from co-morbidities that may affect walking patterns, and must have moderate to severe COPD with no other pulmonary or cardiac issues.
(Eligible participants will undergo a screening process which includes 6-minute walking test, medical history exam, and spirometry evaluation.) 3) Intervention and evaluation: The experimental collection will be conducted at the Biomechanics Research Building at the University of Nebraska at Omaha.
Participants are required to participate in two sessions on two separate days, both including a 30-minute walking session with one session wearing the hip exoskeleton and the other session without the device.
調査の概要
研究の種類
介入
入学 (推定)
10
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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Nebraska
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Omaha、Nebraska、アメリカ、68182
- UNO Biomechanics
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コンタクト：
- Farahnaz Fallahtafti
- 電話番号：4025543075
- メール：ffallahtafti@unomaha.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:
- COPD Diagnosis & Severity: Documented FEV1/FVC ratio of < 0.7 and a post-bronchodilator FEV1% predicted between 30% and 80% (classifying as moderate to severe COPD).
- Age Requirement: Must be between 45 and 75 years old.
- Body Mass Index (BMI): Must have a BMI of less than 35 kg/m^2.
- Medical Clearance & Screening: Must undergo post-bronchodilator spirometry, successfully pass the screening protocol, and receive formal clearance for participation from a physician.
Exclusion Criteria:
- Failing to pass the initial spirometry test.
- Not being formally cleared for participation by a physician.
- Having a diagnosed pulmonary or cardiac issue that would pose a safety hazard during the laboratory treadmill exercise trials.
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：デバイスの実現可能性
- 割り当て：ランダム化
- 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 |
|---|---|
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介入なし：Standard Walking (No Hip Exoskeleton)
Subjects will walk on a treadmill at a preferred speed.
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実験的：Hip Exoskeleton-Assisted Walking
Subjects will walk on a treadmill while wearing a hip exoskeleton providing them assistance.
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The intervention is a wearable hip exoskeleton designed to provide assistive torque during treadmill walking.
During the assisted walking condition, participants will wear the exoskeleton secured around the waist and thighs.
The device will provide powered assistance to the hip joints during walking to reduce the physical demand of locomotion.
Participants will complete a 30-minute treadmill walking session at an individualized workload determined during an initial exercise calibration visit.
The effects of hip exoskeleton assistance will be evaluated by comparing physiological, respiratory, biomechanical, and exercise tolerance outcomes with a standard walking condition performed without exoskeleton assistance.
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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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Respiratory Rate and Timing
時間枠：Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
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Measured continuously in real-time using Respiratory Inductance Plethysmography bands worn around the chest and abdomen.
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Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
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Locomotor-Respiratory Coupling (LRC) Ratios
時間枠：Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
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Quantifies the frequency coupling and synchronization between breathing cycles (via RIP bands) and walking cycles (via an SMTEC footswitch system to detect heel strikes).
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Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
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Dyspnea (Perceived Breathlessness)
時間枠：Assessed at the end of each treadmill walking bout during the 30-minute exercise session.
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Evaluated at the end of each exercise bout using the Modified Borg Scale, ranging from 0 (no breathlessness) to 10 (maximum breathlessness)
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Assessed at the end of each treadmill walking bout during the 30-minute exercise session.
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Dynamic Hyperinflation
時間枠：Measured via spirometry at baseline (pre-exercise) and immediately following the treadmill walking session.
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Evaluated by monitoring the reduction in Inspiratory Capacity (the maximum volume of air inhaled after a regular, calm exhalation) via baseline and post-exercise spirometry.
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Measured via spirometry at baseline (pre-exercise) and immediately following the treadmill walking session.
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Walking Kinematics
時間枠：Continuously recorded during the active 30-minute treadmill walking period in each session.
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Captured at 100 Hz using a 17-camera high-speed digital motion capture system with reflective anatomical markers placed on the lower limbs.
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Continuously recorded during the active 30-minute treadmill walking period in each session.
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Total Walking Time
時間枠：Recorded as the exact cumulative duration of all active walking bouts during the 30-minute session.
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Measured precisely using digital stopwatches to record the exact duration of walking bouts during the 30-minute session.
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Recorded as the exact cumulative duration of all active walking bouts during the 30-minute session.
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Metabolic Cost / Metabolic Equivalents of Task (METs)
時間枠：Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
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Determined by measuring net O2 consumption and CO2 production using indirect calorimetry.
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Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
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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。
スポンサー
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9月1日
一次修了 (推定)
2027年9月1日
研究の完了 (推定)
2028年9月1日
試験登録日
最初に提出
2026年7月8日
QC基準を満たした最初の提出物
2026年7月8日
最初の投稿 (実際)
2026年7月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月14日
QC基準を満たした最後の更新が送信されました
2026年7月8日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- COPD
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?
いいえ
IPD プランの説明
As this is a pilot study intended to generate preliminary data and establish feasibility, individual participant data (IPD) will not be publicly shared at this stage.
Data sharing will be re-evaluated during future, fully powered randomized clinical trials.
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
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