Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD
8 de julio de 2026 actualizado por: Farahnaz Fallahtafti, University of Nebraska
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
10
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Nebraska
-
Omaha, Nebraska, Estados Unidos, 68182
- UNO Biomechanics
-
Contacto:
- Farahnaz Fallahtafti
- Número de teléfono: 4025543075
- Correo electrónico: ffallahtafti@unomaha.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Viabilidad del dispositivo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Respiratory Rate and Timing
Periodo de tiempo: 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.
|
Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
|
|
Locomotor-Respiratory Coupling (LRC) Ratios
Periodo de tiempo: 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).
|
Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
|
|
Dyspnea (Perceived Breathlessness)
Periodo de tiempo: 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)
|
Assessed at the end of each treadmill walking bout during the 30-minute exercise session.
|
|
Dynamic Hyperinflation
Periodo de tiempo: 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.
|
Measured via spirometry at baseline (pre-exercise) and immediately following the treadmill walking session.
|
|
Walking Kinematics
Periodo de tiempo: 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.
|
Continuously recorded during the active 30-minute treadmill walking period in each session.
|
|
Total Walking Time
Periodo de tiempo: 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.
|
Recorded as the exact cumulative duration of all active walking bouts during the 30-minute session.
|
|
Metabolic Cost / Metabolic Equivalents of Task (METs)
Periodo de tiempo: 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.
|
Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de septiembre de 2027
Finalización del estudio (Estimado)
1 de septiembre de 2028
Fechas de registro del estudio
Enviado por primera vez
8 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de julio de 2026
Publicado por primera vez (Actual)
14 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- COPD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .