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

NCT06999213 | Not Yet Recruiting Early Phase 1

• 1 other identifier: STU00223221
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Electromyography (EMG) amplitude during walking under each intervention condition

  Muscle activation (specifically voltage amplitude) using wearable surface EMG of the gastrocnemius, lateral gastrocnemius, tibialis anterior, soleus, biceps femoris, rectus femoris, and gluteus maximus.

  Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)

Secondary Outcomes (3)

• 6 Minute Walk Test

  Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)

• 10 Meter Walk Test

  Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)

• Gait Symmetry

  Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)

Study Arms (2)

Group 1

EXPERIMENTAL

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

Other: Assist; Other: Resist; Other: Slack

Group 2

EXPERIMENTAL

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

Other: Assist; Other: Resist; Other: Slack

Interventions

Assist OTHER

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

Group 1; Group 2

Resist OTHER

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

Also known as: Anti-Assistance

Group 1; Group 2

Slack OTHER

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

MeSH Terms

Interventions

Insemination, Artificial, Heterologous

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• James L Patton, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Camardo

CONTACT

224-422-7182; mcamardo@sralab.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All participants will receive either intervention, but the order in which they receive it will be randomized.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 31, 2025
• Study Start: January 31, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share