Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591780
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to collect data to improve gait function in individuals with Diabetic Peripheral Neuropathy DPN
The primary goals are to evaluate
Biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN
Biofeedback-induced changes in plantar pressure propulsion and biomechanics during gait in individuals with DPN
The participants will be required to complete
Questionnaires
Clinical examination
3-Dimensional gait analysis on an instrumented treadmill
Visual and auditory biofeedback on the participants propulsion and plantar pressure metrics provided by a projector screen during walking
The primary goals are to evaluate
Biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN
Biofeedback-induced changes in plantar pressure propulsion and biomechanics during gait in individuals with DPN
The participants will be required to complete
Questionnaires
Clinical examination
3-Dimensional gait analysis on an instrumented treadmill
Visual and auditory biofeedback on the participants propulsion and plantar pressure metrics provided by a projector screen during walking
Detailed Description:
Over 38 million adults in the United States 1 in 7 are living with Diabetes Mellitus DM of which diabetic peripheral neuropathy DPN is the most common complication affecting more than 50 of individuals with DM DPN causes both sensory and motor impairments of the foot and ankle leading to reduced functional mobility and increased ulceration and amputation risk Propulsion and plantar pressure are two key interrelated gait parameters contributing to walking function and ulceration risk respectively Real-time biofeedback is a non-invasive rehabilitation strategy with significant promise for targeting gait impairments by providing the user with quantitative information regarding a targeted performance variable
In this study the team will evaluate multi-joint lower extremity biomechanical responses to univariate propulsion and plantar pressure biofeedback Secondly the team will use identified biomechanical compensations to propulsion and plantar pressure biofeedback to develop a multi-variable implicit individualized visual biofeedback program to improve gait function in individuals with DPN Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow us to design more informed and effective gait rehabilitation interventions aimed at preventing deleterious outcomes such as ulceration and amputation that can be tailored to individual patient characteristics
In this study the team will evaluate multi-joint lower extremity biomechanical responses to univariate propulsion and plantar pressure biofeedback Secondly the team will use identified biomechanical compensations to propulsion and plantar pressure biofeedback to develop a multi-variable implicit individualized visual biofeedback program to improve gait function in individuals with DPN Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow us to design more informed and effective gait rehabilitation interventions aimed at preventing deleterious outcomes such as ulceration and amputation that can be tailored to individual patient characteristics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None