Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hip Exoskeleton-Assisted Walking.
- Who it may be relevant to
- Registry conditions: COPD (Chronic Obstructive Pulmonary Disease). Basic parameters: 45 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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
Primary outcome measures
- Respiratory Rate and Timing [Time frame: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.]
- Locomotor-Respiratory Coupling (LRC) Ratios [Time frame: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.]
- Dyspnea (Perceived Breathlessness) [Time frame: Assessed at the end of each treadmill walking bout during the 30-minute exercise session.]
- Dynamic Hyperinflation [Time frame: Measured via spirometry at baseline (pre-exercise) and immediately following the treadmill walking session.]
- Walking Kinematics [Time frame: Continuously recorded during the active 30-minute treadmill walking period in each session.]
- Total Walking Time [Time frame: Recorded as the exact cumulative duration of all active walking bouts during the 30-minute session.]
- Metabolic Cost / Metabolic Equivalents of Task (METs) [Time frame: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- UNO Biomechanics — Omaha
Identifiers
NCT: NCT07703527 · COPD