Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
Study NCT ID:
NCT04323969
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
2020-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gait Modification for Knee Osteoarthritis
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Foot Progression Angle Modification: an Exploratory Six-week Intervention in People With Knee Osteoarthritis
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-related laboratory shutdown.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENSMOD
Brief Summary:
This randomized clinical trial will compare the changes in performance, biomechanical and clinical outcomes before and after a six-week gait modification intervention. Participants with knee osteoarthritis will attend in-lab assessments and practice, while also performing daily, at-home walking tracked using a custom sensorized shoe.
Detailed Description:
Greater toe-in or toe-out angles during walking are potential biomechanical management strategies for medial compartment knee osteoarthritis (OA). Multi-week clinical trials demonstrate the biomechanical efficacy and potential clinical efficacy. However, walking biomechanics have only been assessed within laboratory environments and performance of the modifications during daily at-home walking is currently unknown. Furthermore, the modifications have largely been instructed using a specific target, requiring motor learning. No study has examined whether a self-directed strategy is feasible and will produce significant improvements in biomechanical and clinical outcomes. Moreover, objective real-world performance of these modifications is unknown and may explain the previous inconsistent clinical results. This study will address these gaps. The investigators hypothesize that real-world performance of the modifications will improve over the intervention and that both groups will exhibit improvements in biomechanical and clinical outcomes at follow up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: