Development and Validation of an Instrumented Ankle-foot Orthosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Foot Drop
- Sponsor
- TOPMED
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Heel strike angle
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Heel strike angle
Time Frame: 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 Temporal parameters
Time Frame: 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).
Gait Spatial parameters
Time Frame: 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
Time Frame: 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.