Development and Validation of an Instrumented Ankle-foot Orthosis

NCT06115161 | Withdrawn

• 1 other identifier: 241_Tur_ApEval
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Drop

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Gait Analysis

EXPERIMENTAL

Gait analysis with the instrumented orthosis as well as a reference sysmtem (Vicon Vantage 5).

Device: Instrumented Orthosis

Interventions

Instrumented Orthosis DEVICE

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

Gait Analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having foot drop
• Being a clinician who treats foot drop patients
• Having foot drop

You may not qualify if:

• Not being able to walk without a cane or a walker
• Having lower extremity spasticity

Sponsors & Collaborators

• TOPMED: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator
• Turbomed Orthotics Inc.: collaborator

Study Sites (1)

TOPMED

Québec, G1S1C1, Canada

Location

MeSH Terms

Conditions

Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Trial with condition crossover

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: November 2, 2023
• Study Start: September 13, 2023
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)