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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Device: Hip Exoskeleton-Assisted Walking

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68182
      • UNO Biomechanics
      • Contact: Farahnaz Fallahtafti; Phone Number: 4025543075; Email: ffallahtafti@unomaha.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Walking (No Hip Exoskeleton); Subjects will walk on a treadmill at a preferred speed.
Experimental: Hip Exoskeleton-Assisted Walking; Subjects will walk on a treadmill while wearing a hip exoskeleton providing them assistance.	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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Nebraska

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No