Development and Validation of an Instrumented Ankle-foot Orthosis

TOPMED

Status: Withdrawn

Conditions: Foot Drop

Treatments: Device: Instrumented Orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06115161

241_Tur_ApEval

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Patients questionnaire:

• Having foot drop

Inclusion Criteria for Clinician questionnaire:

• Being a clinician who treats foot drop patients

Inclusion Criteria for Gait analysis:

• Having foot drop

Exclusion Criteria for Gait analysis:

• Not being able to walk without a cane or a walker
• Having lower extremity spasticity

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Gait Analysis

Experimental group

Description:

Gait analysis with the instrumented orthosis as well as a reference sysmtem (Vicon Vantage 5).

Treatment:

Device: Instrumented Orthosis