Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD
8 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
10
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Nebraska
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Omaha, Nebraska, États-Unis, 68182
- UNO Biomechanics
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Contact:
- Farahnaz Fallahtafti
- Numéro de téléphone: 4025543075
- E-mail: ffallahtafti@unomaha.edu
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Faisabilité de l'appareil
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Standard Walking (No Hip Exoskeleton)
Subjects will walk on a treadmill at a preferred speed.
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Respiratory Rate and Timing
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 septembre 2027
Achèvement de l'étude (Estimé)
1 septembre 2028
Dates d'inscription aux études
Première soumission
8 juillet 2026
Première soumission répondant aux critères de contrôle qualité
8 juillet 2026
Première publication (Réel)
14 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- COPD
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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