NCT06115161

Development and Validation of an Instrumented Ankle-foot Orthosis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: TOPMED · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Dragging one's toes on an uneven floor or a carpet can lead to tripping and falling. TurboMed Orthotics Inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. In order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. Thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. The instrumented orthosis will also be compared to a reference system in a validation effort.

Conditions

• Foot Drop

Interventions

Type	Name	Description
DEVICE	Instrumented Orthosis	Gait analysis will be performed with the instrumented orthosis as well as the reference system.

Timeline

• Start date: 2023-09-13
• Primary completion: 2023-09-13
• Completion: 2023-09-13
• First posted: 2023-11-02
• Last updated: 2025-03-20

Locations

1 site across 1 country: Canada