Development and Validation of an Instrumented Ankle-foot Orthosis

Study Overview
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Brief Summary
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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.

Official Title
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Development and Validation of an Instrumented Ankle-foot Orthosis

Conditions
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Foot Drop

Intervention / Treatment
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* Device: Instrumented Orthosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Trial with condition crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gait Analysis<br>Gait analysis with the instrumented orthosis as well as a reference sysmtem (Vicon Vantage 5). | Device: Instrumented Orthosis<br>* Gait analysis will be performed with the instrumented orthosis as well as the reference system.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankle foot orthosis, validation, survey, gait analysis, biomecanics