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This Study Evaluates the Use of a Data-driven Lower Limb Exoskeleton Controller for Stroke Rehabilitation.

27 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • Rehabilitation Laboratory in the Ford Robotics Building on the University of Michigan North Campus

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Experimental Arm
Training with the new "unified control framework" (the smart, adaptive robotic exoskeleton).
Apparaat: Unified Control Framework for Lower-Limb Powered Orthosis
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.
Actieve vergelijker: Active Comparator Arm
Training with a "conventional controller" (the standard robotic exoskeleton controller).
Apparaat: Conventional Robotic Controller
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Walking Speed
Tijdsspanne: Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
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.
Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
Functional Mobility and Balance
Tijdsspanne: Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
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.
Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Acute Within-Session Changes in Spatial Gait Symmetry
Tijdsspanne: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
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.
Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
Acute Within-Session Changes in Ground Reaction Force Symmetry
Tijdsspanne: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
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.
Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
Acute Within-Session Changes in Joint Range of Motion
Tijdsspanne: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
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.
Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Michigan

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

19 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

27 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HUM00287262

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

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