Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD

Обзор

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.

Вмешательства

• Устройство Hip Exoskeleton-Assisted Walking
  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. Th

Первичные конечные точки

• Respiratory Rate and Timing [Срок оценки: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.]
• Locomotor-Respiratory Coupling (LRC) Ratios [Срок оценки: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.]
• Dyspnea (Perceived Breathlessness) [Срок оценки: Assessed at the end of each treadmill walking bout during the 30-minute exercise session.]
• Dynamic Hyperinflation [Срок оценки: Measured via spirometry at baseline (pre-exercise) and immediately following the treadmill walking session.]
• Walking Kinematics [Срок оценки: Continuously recorded during the active 30-minute treadmill walking period in each session.]
• Total Walking Time [Срок оценки: Recorded as the exact cumulative duration of all active walking bouts during the 30-minute session.]
• Metabolic Cost / Metabolic Equivalents of Task (METs) [Срок оценки: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• UNO Biomechanics — Omaha

Идентификаторы

NCT: NCT07703527 · COPD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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