An interventional study of Instrumented Orthosis in Foot Drop, sponsored by TOPMED. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by TOPMED · Not applicable, Interventional, and Device feasibility
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.
41 studies on the registry are indexed under Peroneal Neuropathies; 9 are open to participants now.
Browse Peroneal Neuropathies studies →TOPMED is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
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Inclusion Criteria for Patients questionnaire:
Inclusion Criteria for Clinician questionnaire:
Inclusion Criteria for Gait analysis:
Exclusion Criteria for Gait analysis:
Gait analysis with the instrumented orthosis as well as a reference sysmtem (Vicon Vantage 5).
Device: Instrumented Orthosis
Gait analysis will be performed with the instrumented orthosis as well as the reference system.
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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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