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Development and Validation of an Instrumented Ankle-foot Orthosis

NCT06115161 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-03-20

No results posted yet for this study

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

DEVICE

Instrumented Orthosis

Gait analysis will be performed with the instrumented orthosis as well as the reference system.

Sponsors & Collaborators

  • Natural Sciences and Engineering Research Council, Canada

    collaborator OTHER

  • Turbomed Orthotics Inc.

    collaborator UNKNOWN

  • TOPMED

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2023-09-13
Completion
2023-09-13

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06115161 on ClinicalTrials.gov