NCT07179627

Ankle Exoskeleton for Stroke Gait Enhancement

Powered Ankle Exoskeleton for Stroke Survivors With Gait Impairment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Georgia Institute of Technology · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This work will focus on new algorithms for robotic ankle exoskeletons and testing these in human subject tests. Individuals who have previously had a stroke will walk while wearing a robotic exoskeleton on a specialized treadmill as well as during other movement tasks (e.g., overground, stairs, ramps). The study will compare the performance of the advanced algorithm with not using the device to determine the clinical benefit.

Detailed description

The focus of this work is on a proposed novel artificial intelligence (AI) system that self-adapts control policy in powered exoskeletons to aid deployment systems that personalize to individual patient gait. Individuals post-stroke have a broad range of mobility challenges, including asymmetric gait, substantially decreased SSWS, and reduced stability, and therefore have greatly impaired overall mobility independence in the community. The investigators expect the proposed novel controller, capable of personalization to such variable and asymmetric gait patterns, will have significant benefits towards increasing community independence and mobility for patients post stroke. Stroke survivor participants will be fitted with an ankle exoskeleton and proceed to walk on a treadmill or perform various movement tasks. The same tasks will be performed by the participants without wearing the ankle exoskeleton to serve as a baseline. The investigators expect improved outcomes in the powered ankle exoskeleton compared to baseline conditions.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Ankle exoskeleton	The ankle exoskeleton provides bilateral torque assistance at the ankle joints during common functional tasks such as level-ground walking, stair and ramp ascent, and other daily activities, thereby reducing the mechanical workload and supporting more effective community ambulation. In particular, the device is designed to address drop-foot on the paretic side by delivering bidirectional assistance, which helps improve toe clearance during swing as well as push-off during stance. As a wearable assistive device, assistance is applied only while the device is worn.
OTHER	Baseline (no ankle exoskeleton)	The intervention will serve as a baseline where participants will be asked to perform the tasks without wearing an ankle exoskeleton.

Timeline

• Start date: 2026-02-09
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-09-18
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study