Lower Limb ExoNET: Development and Evaluation for Gait Assistance With Stroke Survivors

NCT ID: NCT06999213

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-12-31

Brief Summary

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Stroke-related gait impairments, such as poor limb coordination, imbalance, and reduced push-off strength, are often addressed using robotic systems or electrical stimulation, which can be costly, invasive, or insufficient for long-term recovery. Current devices often assist movement but fail to promote functional motor learning. Research supports rehabilitation strategies that amplify gait errors to drive neuroplasticity and adaptation. The LegExoNET (Exoskeletal Network for Elastic Torque) is a novel, passive wearable exoskeleton designed to address this need by enabling both assistive and therapeutic gait training. It stores and releases elastic energy to aid movement while allowing natural joint motion. The system aims to support individuals post-stroke transitioning to independent rehabilitation by offering a lightweight, affordable, and adaptive solution. Initial testing will focus on healthy individuals to assess safety and feasibility before expanding to stroke populations. The LegExoNET has the potential to enhance gait recovery and reduce therapist burden through error augmentation and personalized support, both in clinical and at-home settings.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
All participants will receive either intervention, but the order in which they receive it will be randomized.

Study Groups

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Group 1

Participants will receive Sham → Assist → Resist in a crossover design.

Group Type EXPERIMENTAL

Assist

Intervention Type OTHER

The device will provide assistive torques to support either ankle, knee, and/or hip movements.

Resist

Intervention Type OTHER

The device will apply resistive torques to exaggerate gait asymmetries, facilitating error augmentation.

Slack

Intervention Type OTHER

The device will be worn but will not generate any torque.

Group 2

Participants will receive Sham → Resist → Assist in a crossover design

Group Type EXPERIMENTAL

Assist

Intervention Type OTHER

The device will provide assistive torques to support either ankle, knee, and/or hip movements.

Resist

Intervention Type OTHER

The device will apply resistive torques to exaggerate gait asymmetries, facilitating error augmentation.

Slack

Intervention Type OTHER

The device will be worn but will not generate any torque.

Interventions

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Assist

The device will provide assistive torques to support either ankle, knee, and/or hip movements.

Intervention Type OTHER

Resist

The device will apply resistive torques to exaggerate gait asymmetries, facilitating error augmentation.

Intervention Type OTHER

Slack

The device will be worn but will not generate any torque.

Intervention Type OTHER

Other Intervention Names

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Anti-Assistance

Eligibility Criteria

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Inclusion Criteria

* Age 18-70 years old
* Ability to provide informed consent
* Capable of ambulating without the use of assistive devices for 2 hours

Exclusion Criteria

* History of stroke, SCI, or other neurological medical diagnoses
* Pregnant
* Severe medical diagnoses (e.g. cardiovascular, orthopedic)
* Skin allergies or irritation; open wounds
* Prisoners
* Cognitively impaired adults
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shirley Ryan AbilityLab

OTHER

Sponsor Role lead

Responsible Party

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James Lanphier Patton

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James L Patton, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Central Contacts

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Marc Camardo

Role: CONTACT

224-422-7182

Other Identifiers

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STU00223221

Identifier Type: -

Identifier Source: org_study_id

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