NCT06923293

Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis

Individualizing Powered Orthotic Intervention for Improved Gait Outcomes Using ML-enabled Methods

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.

Detailed description

The long-term goal of this project is to improve the outcomes of robot-assisted exercise interventions for patients with reconstructed lower limb following high-energy lower extremity traumas using novel machine learning methods to enable individualized ankle foot orthosis (AFO) designs and self-adaptive AFO assistance. The main hypothesis predicts greater comfort and lower pain levels when using the new AFO as well as improvements in gait mechanics, which will outperform those induced by patients' daily-use AFOs. The main goal is this adaptive assistance will encourage the wearer's active engagement in RAGT thereby promoting patient self-efficacy/satisfaction and leading to improvements in ambulation after a 6-week rehabilitation program.

Conditions

• Lower Limb Injury

Interventions

Type	Name	Description
DEVICE	Utilization of motorized orthosis	While part of this study, participants will be fitted for the motorized orthosis and will complete walking tests with and without the AFO.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-04-11
• Last updated: 2025-08-26

Locations

1 site across 1 country: United States