Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06115161
Other study ID # 241_Tur_ApEval
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01237860 - Evaluation of the Safety and Performance of the NESS L300 Plus System Phase 3
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
Completed NCT05163782 - Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop 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