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

NCT07703527 | Not Yet Recruiting

• 1 other identifier: COPD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (7)

• Respiratory Rate and Timing

  Measured continuously in real-time using Respiratory Inductance Plethysmography bands worn around the chest and abdomen.

  Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.

• Locomotor-Respiratory Coupling (LRC) Ratios

  Quantifies the frequency coupling and synchronization between breathing cycles (via RIP bands) and walking cycles (via an SMTEC footswitch system to detect heel strikes).

  Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.

• Dyspnea (Perceived Breathlessness)

  Evaluated at the end of each exercise bout using the Modified Borg Scale, ranging from 0 (no breathlessness) to 10 (maximum breathlessness)

  Assessed at the end of each treadmill walking bout during the 30-minute exercise session.

• Dynamic Hyperinflation

  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.

  Measured via spirometry at baseline (pre-exercise) and immediately following the treadmill walking session.

• Walking Kinematics

  Captured at 100 Hz using a 17-camera high-speed digital motion capture system with reflective anatomical markers placed on the lower limbs.

  Continuously recorded during the active 30-minute treadmill walking period in each session.

• Total Walking Time

  Measured precisely using digital stopwatches to record the exact duration of walking bouts during the 30-minute session.

  Recorded as the exact cumulative duration of all active walking bouts during the 30-minute session.

• Metabolic Cost / Metabolic Equivalents of Task (METs)

  Determined by measuring net O2 consumption and CO2 production using indirect calorimetry.

  Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.

Study Arms (2)

Standard Walking (No Hip Exoskeleton)

NO INTERVENTION

Subjects will walk on a treadmill at a preferred speed.

Hip Exoskeleton-Assisted Walking

EXPERIMENTAL

Subjects will walk on a treadmill while wearing a hip exoskeleton providing them assistance.

Device: Hip Exoskeleton-Assisted Walking

Interventions

Hip Exoskeleton-Assisted Walking DEVICE

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.

Hip Exoskeleton-Assisted Walking

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

UNO Biomechanics

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)