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

University of Michigan

Status

Begins enrollment this month

Conditions

Stroke

Treatments

Device: Unified Control Framework for Lower-Limb Powered Orthosis

Device: Conventional Robotic Controller

Study type

Interventional

Funder types

Other

Identifiers

NCT07616167

HUM00287262

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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).