Development and Validation of an Instrumented Ankle-foot Orthosis

Foot Drop Clinical Trial

Official title:

Development and Validation of an Instrumented Ankle-foot Orthosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115161
• Other study ID #: 241_Tur_ApEval
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: May 2024
• Source: TOPMED
• Contact: Edith Martin, PhD
• Phone: 4187801301
• Email: emartin[@]topmed.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Foot Drop
• Peroneal Neuropathies

Intervention

Device:
• Instrumented Orthosis
Gait analysis will be performed with the instrumented orthosis as well as the reference system.

Locations

Country	Name	City	State
Canada	TOPMED	Québec

Sponsors (3)

Lead Sponsor	Collaborator
TOPMED	Natural Sciences and Engineering Research Council, Canada, Turbomed Orthotics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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