COPD (Chronic Obstructive Pulmonary Disease)NCT07703527
Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD
A study testing Hip Exoskeleton-Assisted Walking in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Hip Exoskeleton-Assisted Walking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UNO Biomechanics
Omaha, Nebraska, 68182
Farahnaz Fallahtafti, 4025543075, ffallahtafti@unomaha.edu
About this study
- 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.
- Being tested
- Hip Exoskeleton-Assisted Walking
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip Exoskeleton-Assisted WalkingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hip Exoskeleton-Assisted Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate and Timing
Measured continuously in real-time using Respiratory Inductance Plethysmography bands worn around the chest and abdomen.
Measured: 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).
Measured: 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)
Measured: 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: 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.
Measured: 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.
Measured: 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.
Measured: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farahnaz Fallahtafti, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703527
- Sponsor's protocol ID
- COPD
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD
- ClinicalTrials.gov ID
- NCT07703527
- Acronym / sponsor ID
- COPD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Walking (No Hip Exoskeleton) | No intervention | –Subjects will walk on a treadmill at a preferred speed. |
| Hip Exoskeleton-Assisted Walking | Experimental | Device: Hip Exoskeleton-Assisted WalkingSubjects will walk on a treadmill while wearing a hip exoskeleton providing them assistance. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip Exoskeleton-Assisted WalkingThe 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. | Device | Hip Exoskeleton-Assisted Walking |
Primary outcome
Respiratory Rate and Timing
Time frame: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
Measured continuously in real-time using Respiratory Inductance Plethysmography bands worn around the chest and abdomen.
Locomotor-Respiratory Coupling (LRC) Ratios
Time frame: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
Quantifies the frequency coupling and synchronization between breathing cycles (via RIP bands) and walking cycles (via an SMTEC footswitch system to detect heel strikes).
Dyspnea (Perceived Breathlessness)
Time frame: Assessed at the end of each treadmill walking bout during the 30-minute exercise session.
Evaluated at the end of each exercise bout using the Modified Borg Scale, ranging from 0 (no breathlessness) to 10 (maximum breathlessness)
Dynamic Hyperinflation
Time frame: Measured via spirometry at baseline (pre-exercise) and immediately following the treadmill walking session.
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.
Walking Kinematics
Time frame: Continuously recorded during the active 30-minute treadmill walking period in each session.
Captured at 100 Hz using a 17-camera high-speed digital motion capture system with reflective anatomical markers placed on the lower limbs.
Total Walking Time
Time frame: Recorded as the exact cumulative duration of all active walking bouts during the 30-minute session.
Measured precisely using digital stopwatches to record the exact duration of 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.
Determined by measuring net O2 consumption and CO2 production using indirect calorimetry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Exoskeleton-Assisted Walking in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Rate and Timing (time frame: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.