Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965336
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-07-20
Brief Title:
Walking Function in Diabetic Peripheral Neuropathy
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Walking Function in Individuals With Diabetic Peripheral Neuropathy Biomechanical Mechanisms and Implications for Clinical Outcomes and Gait Retraining
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to 1 examine the differences in walking function and movement patterns between individuals with diabetic peripheral neuropathy and healthy adults with no known conditions 2 examine if receiving feedback on walking form will help change walking patterns and 3 examine the feasibility safety and preliminary effects of walking training with feedback on walking function in individuals with diabetic peripheral neuropathy
Detailed Description:
Over 34 million adults in the United States are living with Diabetes Mellitus DM Diabetic peripheral neuropathy DPN is the most common complication affecting 50 of individuals with DM Consequences of DPN include reduced sensation and feedback from the foot and lower limb and increased plantar pressures predisposing patients to ulcers and lower extremity amputation Individuals with DPN experience decreased quality of life compared with their healthy and non-neuropathic DM peers and report problems with mobility daily activities pain and discomfort Additionally people with DPN display reduced functional ambulation step counts and walking speed Though increases in physical activity and functional capacity have been associated with improvements in quality of life DPN poses a unique challenge in mitigating risk while pursuing traditional exercise and walking programs
Traditional gait training programs used to improve walking function may increase ulceration risk making these interventions unsuitable if not tailored for people with DPN The goal of this study is to elucidate the underlying biomechanical mechanisms contributing to the inter-relationships between plantar pressure and propulsion in individuals with DPN and to examine the safety and feasibility of using real-time biofeedback to modify plantar pressure and propulsion during gait
The aims of this study are to evaluate 1 biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN 2 biofeedback-induced changes in plantar pressure propulsion and biomechanics during gait in individuals with DPN and age-similar controls and 3 the acceptability feasibility safety and preliminary effects of gait training in individuals with DPN Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow for the design of 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
Able-bodied participants will complete three experimental sessions and participants with DPN will complete a total of seven experimental sessions Each session will be approximately 2-3 hours in duration
Traditional gait training programs used to improve walking function may increase ulceration risk making these interventions unsuitable if not tailored for people with DPN The goal of this study is to elucidate the underlying biomechanical mechanisms contributing to the inter-relationships between plantar pressure and propulsion in individuals with DPN and to examine the safety and feasibility of using real-time biofeedback to modify plantar pressure and propulsion during gait
The aims of this study are to evaluate 1 biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN 2 biofeedback-induced changes in plantar pressure propulsion and biomechanics during gait in individuals with DPN and age-similar controls and 3 the acceptability feasibility safety and preliminary effects of gait training in individuals with DPN Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow for the design of 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
Able-bodied participants will complete three experimental sessions and participants with DPN will complete a total of seven experimental sessions Each session will be approximately 2-3 hours in duration
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K01HD107294 | NIH | None | httpsreporternihgovquickSearchK01HD107294 |