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Development and Validation of an Instrumented Ankle-foot Orthosis

Development and Validation of an Instrumented Ankle-foot Orthosis

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06115161
Enrollment
0
Registered
2023-11-02
Start date
2023-09-13
Completion date
2023-09-13
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Drop

Keywords

ankle foot orthosis, validation, survey, gait analysis, biomecanics

Brief 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.

Interventions

DEVICEInstrumented Orthosis

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

Sponsors

Natural Sciences and Engineering Research Council, Canada
CollaboratorOTHER
Turbomed Orthotics Inc.
CollaboratorUNKNOWN
TOPMED
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention model description

Trial with condition crossover

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gait Temporal parametersDuring the intervention, 10 walking trials will be assessed, all trials will be performed in the same sessionGait 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 angleDuring the intervention, 10 walking trials will be assessed, all trials will be performed in the same sessionHeel strike angle measured by the instrumented orthosis and the reference system
Gait Spatial parametersDuring the intervention, 10 walking trials will be assessed, all trials will be performed in the same sessionGait Spatial parameters measured by the instrumented orthosis and the reference system, in meters, these include the length and width of the stride.
Gait speedDuring the intervention, 10 walking trials will be assessed, all trials will be performed in the same sessionGait speed measured by the instrumented orthosis and the reference system, in meters per second.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026