This Study Evaluates the Use of a Data-driven Lower Limb Exoskeleton Controller for Stroke Rehabilitation.
27 maja 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Typ studiów
Interwencyjne
Zapisy (Szacowany)
20
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- Rehabilitation Laboratory in the Ford Robotics Building on the University of Michigan North Campus
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Walking Speed
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Acute Within-Session Changes in Spatial Gait Symmetry
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 października 2026
Zakończenie podstawowe (Szacowany)
31 grudnia 2027
Ukończenie studiów (Szacowany)
31 grudnia 2027
Daty rejestracji na studia
Pierwszy przesłany
19 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
27 maja 2026
Pierwszy wysłany (Rzeczywisty)
1 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
1 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HUM00287262
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Tak
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Uderzenie
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IRCCS San Raffaele RomaMinistry of Health, ItalyRekrutacyjnyUderzenie | Sabacute StrokeWłochy
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University of ZurichNieznany