This Study Evaluates the Use of a Data-driven Lower Limb Exoskeleton Controller for Stroke Rehabilitation.
27 de mayo de 2026 actualizado por: Robert D Gregg, University of Michigan
From Stroke Rehabilitation to Independence: An Impairment-Aware Control Framework for Adaptive Exoskeleton Assistance
The goal of this clinical trial is to test a new, impairment-aware robotic control software framework to see if its smart adaptation can improve walking recovery in healthy adults and chronic stroke survivors. .
The main questions it aims to answer are:
Can the new control software safely use sensors and machine learning to predict and instantly adapt to a user's specific walking needs?
Does training with a robotic device driven by this new adaptive control framework improve walking speed and overall mobility in stroke survivors?
Researchers will compare a lower-limb orthosis operating under the new "smart" control software (which adapts to the user's impairment) to the same device operating under a standard, non-adaptive controller (which uses rigid or fixed assistance) to see if the new control approach leads to greater improvements in walking ability.
Participants will:
Walk on treadmills, flat walkways, or stairs while wearing a robotic leg orthosis driven by the different control software systems being tested.
Wear small tracking tools (like reflective motion-capture markers and muscle activity sensors) so researchers can precisely measure how their movements interact with each control program.
Complete standard walking tests to measure their walking speed and overall mobility under each software condition.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
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
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Rehabilitation Laboratory in the Ford Robotics Building on the University of Michigan North Campus
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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
Sí
Descripción
Inclusion Criteria:
- Cohort 1: Able-Bodied Participants (Initial Validation)
- Healthy young adults.
- No history of neurological, orthopedic, or cardiovascular impairments affecting gait or balance.
- Able to walk independently without assistive devices.
Cohort 2: Stroke Survivors (Clinical Efficacy Pilot)
- Individuals with a documented history of chronic stroke.
- Persistent unilateral lower-limb motor impairment resulting in a pathological gait pattern (heterogeneous gait deficits).
- Stable medical condition allowing for participation in intensive physical rehabilitation tasks.
- Able to provide informed consent.
Exclusion Criteria:
- Severe cognitive or communication impairments that prevent the participant from following safety instructions or reporting discomfort.
- Co-existing neurological conditions (other than stroke) that independently impair locomotion (e.g., Parkinson's disease, Multiple Sclerosis).
- Severe lower-limb joint contractures or orthopedic conditions that mechanically restrict the safe range of motion of the robotic orthosis.
- Skin breakdowns, open wounds, or severe unhealed lesions at the contact points where the powered orthosis interfaces with the lower limbs.
- Any medical contraindication to intensive walking exercise or treadmill training (e.g., unstable angina, severe unmanaged cardiovascular disease).
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Experimental Arm
Training with the new "unified control framework" (the smart, adaptive robotic exoskeleton).
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An AI-driven, machine learning-based control software integrated into a wearable lower-limb powered orthosis.
The system utilizes a Bayesian Neural Network (BNN) to analyze a user's pathological walking patterns (kinematics) in real-time via onboard sensors.
Based on this real-time performance, the device dynamically modulates its physical assistance along a seamless continuum.
It automatically transitions between stiff corrective guidance (position-based gait training) when the user struggles, and compliant, volitional torque support (torque-based assistance) as the user's independent walking ability improves.
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Comparador activo: Active Comparator Arm
Training with a "conventional controller" (the standard robotic exoskeleton controller).
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A standard control paradigm for lower-limb powered orthoses that provides non-adaptive physical assistance during gait training.
Depending on the trial block, the device operates in one of two static modalities: either rigid position-based gait training (GT) that physically guides the patient's limbs through a fixed, predetermined trajectory regardless of effort, or torque-based volitional augmentation (VA) that proportionally amplifies existing muscle output or ground reaction forces.
Unlike the experimental intervention, this controller cannot interpret kinematics in real-time or dynamically modulate assistance along a continuous spectrum based on the user's instantaneous performance.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Walking Speed
Periodo de tiempo: Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
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A standardized clinical assessment used to determine short-distance walking speed over a 10-meter course.
This metric evaluates the preliminary clinical efficacy of the unified control framework compared to the conventional controller in chronic stroke survivors.
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Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
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Functional Mobility and Balance
Periodo de tiempo: Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
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A clinical performance-based measure used to assess dynamic balance, turning agility, and functional mobility.
The test measures the time (in seconds) taken for a participant to rise from a chair, walk 3 meters, turn around, walk back, and sit down.
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Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acute Within-Session Changes in Spatial Gait Symmetry
Periodo de tiempo: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
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Gait symmetry evaluated using the step length symmetry index (SI), calculated from lower-limb kinematics recorded by the exoskeleton's onboard joint encoders and/or motion capture data.
This metric evaluates the immediate corrective effects on walking patterns.
An SI of 0% represents perfect symmetry.
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Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
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Acute Within-Session Changes in Ground Reaction Force Symmetry
Periodo de tiempo: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
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Force symmetry evaluated using the peak vertical ground reaction force ratio between the paretic and non-paretic limbs, measured via the exoskeleton's instrumented insoles and/or force plates.
This evaluates the immediate impact of the control framework on weight-bearing symmetry.
Data are expressed as a dimensionless ratio, where a value of 1.0 indicates perfect symmetry between limbs.
Force is measured in units of Newtons.
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Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
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Acute Within-Session Changes in Joint Range of Motion
Periodo de tiempo: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
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Measurement of the peak angular displacement of the knee, hip and ankle joints (in degrees) during the sagittal plane gait cycle, captured by the exoskeleton's onboard joint encoders and/or a motion capture system.
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Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
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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 octubre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HUM00287262
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.
Sí
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