Development and Validation of an Instrumented Ankle-foot Orthosis

NCT06115161 — Not applicable, Withdrawn, TOPMED
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RegistryNCT06115161
StatusWithdrawn - The instrumented orthosis prototype was never finished.
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, device feasibility
SponsorTOPMED (Other); collaborators: Natural Sciences and Engineering Research Council, Canada, Turbomed Orthotics Inc.
ConditionsFoot Drop
InterventionsInstrumented Orthosis (Device)
Datesstart 2023-09-13, primary completion 2023-09-13, completion 2023-09-13, first posted 2023-11-02, last updated 2025-03-20
Locations1 site in Canada

Related Papers Related Patents Related Grants Related Experts
All trials for Foot Drop All trials of Instrumented Orthosis

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Gait AnalysisExperimentalDevice: Instrumented OrthosisGait analysis with the instrumented orthosis as well as a reference sysmtem (Vicon Vantage 5).
  • Instrumented Orthosis (Device): Gait analysis will be performed with the instrumented orthosis as well as the reference system.

+Outcome measures

Primary outcomes

  • Gait Temporal parameters [During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session]: Gait Temporal parameters measured by the instrumented orthosis and the reference system, in seconds, these include the different phase durations(stride, stance and swing).
  • Heel strike angle [During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session]: Heel strike angle measured by the instrumented orthosis and the reference system
  • Gait Spatial parameters [During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session]: Gait Spatial parameters measured by the instrumented orthosis and the reference system, in meters, these include the length and width of the stride.
  • Gait speed [During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session]: Gait speed measured by the instrumented orthosis and the reference system, in meters per second.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
TOPMEDQuébecCanada