Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05163782
Other study ID # RD-19-0276_OptOrPi
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 19, 2021
Est. completion date June 28, 2023

Study information

Verified date March 2023
Source TOPMED
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this research is to compare the new ankle foot orthosis (AFO) with prior support developed by Turbomed, with the AFO with posterior support from Turbomed as well as two competing AFOs currently on the market. With this research, we seek to answer the following questions: - Is the new AFO as biomechanically efficient as the AFOs currently on the market? - Is the new AFO more comfortable than the AFO currently on the market? - Is the new AFO easier to put on and attach than the AFOs currently on the market?


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date June 28, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Foot drop following surgery or an accident (functional calf, without contracture and not spastic) - Foot drop following a Cerebral Vascular Accident (with or without spasticity, mild to moderate) - Ability to stand and walk alone without technical assistance - Ability to communicate comfort/discomfort Exclusion Criteria: - Sore to one of the feet

Study Design


Related Conditions & MeSH terms


Intervention

Device:
New ankle foot orthosis with anterior support
New ankle foot orthosis with anterior support developed by Turbomed
Ankle foot orthosis with anterior support
Ankle foot orthosis with anterior support from Turbomed
Ankle foot orthosis from competitor 1
Ankle foot orthosis with posterior support from competitor 1
Ankle foot orthosis from competitor 2
Ankle foot orthosis with posterior support from competitor 2

Locations

Country Name City State
Canada TOPMED Québec Quebec

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 Knee flexion angle during gait Maximum, minimum and range of motion of the knee flexion angle during gait. At delivery
Primary Hip flexion angle during gait Maximum, minimum and range of motion of the hip flexion angle during gait. At delivery
Primary Minimum foot clearance Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing. At delivery
Primary Comfort of participants with orthosis Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable). At delivery
Primary Easy to put on orthosis Easy to put on is measured with a Likert scale from 1 (very difficult) to 5 (very easy). At delivery
See also
  Status Clinical Trial Phase
Completed NCT01237860 - Evaluation of the Safety and Performance of the NESS L300 Plus System Phase 3
Recruiting NCT06115161 - Development and Validation of an Instrumented Ankle-foot Orthosis N/A
Completed NCT02483676 - Ankle Robot to Reduce Foot Drop in Stroke N/A
Completed NCT02729636 - Multi-pad FES System for Drop Foot Treatment N/A
Terminated NCT01001390 - The Effects of Ankle Foot Orthoses on Gait Efficiency in Children With Acute Lymphoblastic Leukemia and Foot Drop N/A
Completed NCT05449275 - Effects Of Faradic Current Versus Ankle-Foot Orthosis In Patients With Foot Drop N/A
Completed NCT05346640 - Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation N/A
Completed NCT02123537 - Treating Foot Drop in People With Multiple Sclerosis Using Electrical Stimulation N/A
Completed NCT01977287 - Walking With FES or AFO in People With MS With Foot Drop N/A
Not yet recruiting NCT03530592 - Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project N/A
Terminated NCT04238013 - Neuromodulation of Ankle Muscles in Persons With SCI N/A
Recruiting NCT04934787 - ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation N/A
Completed NCT02693834 - Effects of Two Different Types of Ankle Foot Orthoses on Gait Outcomes in Patients With Subacute Stroke. N/A
Recruiting NCT04594837 - Ankle Robotics After Stroke N/A
Recruiting NCT05801744 - Operant Conditioning of Reflex Pathways to Improve Walking in Individuals Post-stroke N/A
Completed NCT03440632 - Functional Electrical Stimulation During Walking in Cerebral Palsy N/A
Not yet recruiting NCT03556709 - Walking Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project N/A
Withdrawn NCT04137809 - TREAT Foot Drop After Stroke With Ankle Robot N/A
Completed NCT01952613 - Effect of FES Interventions on Gait Dynamics in Stroke Population N/A