Ignite Creation Date:
2024-05-06 @ 1:20 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03995238
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2019-06-20
Brief Title:
Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation
Status:
RECRUITING
Status Verified Date:
2024-04
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:
GEM
Brief Summary:
The population of older Veterans with non-traumatic lower limb amputation is growing Following lower limb amputation asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions poor gait efficiency impaired physical function and compromised skin integrity of the residual limb This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for Veterans with non-traumatic lower limb amputation Additional this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health Ultimately this study aims to improve conventional prosthetic rehabilitation for Veterans with non-traumatic amputation through gait training programs based in motor learning principles resulting in improved gait symmetry and lower incidence of long-term disability after non-traumatic lower limb amputation
Detailed Description:
The focus of this study is to improve walking symmetry in order to optimize walking ability and reduce disability for Veterans with non-traumatic lower limb amputation LLA Over 80 of current LLAs are non-traumatic resulting from complications of pathologies such as diabetes mellitus and peripheral artery disease Despite current declines in total amputation rate among Veterans the population with non-traumatic LLA is growing For example from 2000 to 2004 the relative amputation rate decreased by 34 However due to an increase in the number of Veterans with diabetes during the same period the population of Veterans with diabetes and initial LLA increased by 23 Following LLA excessive gait asymmetry is common Asymmetric gait characteristics are of critical importance as excessive asymmetry may increase the severity of disability experienced by people with non-traumatic LLA and contribute to secondary pain conditions low back pain and osteoarthritis poor gait efficiency declines in physical performance and compromised skin integrity of the residual limb Compared to individuals with traumatic LLA the poor gait performance of those with non-traumatic LLA is further compounded by older age lower premorbid function presence of comorbidities frequent wound development and delayed healing in the residual limb While improving gait symmetry is a goal of conventional prosthetic rehabilitation persistence of gait asymmetry for years after LLA highlights the ineffectiveness of current rehabilitation practices in achieving this goal As a means of improving gait symmetry this study aims to determine the efficacy of error-manipulation gait training using two approaches error-augmentation and error-correction compared to current standard-of-care in a three-arm randomized controlled trial Error-manipulation gait training intervention will be delivered in eight training sessions 2xweek 4 weeks with 54 Veterans 18 per intervention group 18 in control group who have non-traumatic unilateral transtibial LLA It is unclear which if either form of error-manipulation gait training is efficacious for improving persistent gait symmetry in Veterans with non-traumatic LLA Error-augmentation gait training is a promising and novel intervention that involves exaggerating an existing movement error to force the neuromuscular system to correct the error While this form of gait training improved gait symmetry in small studies of individuals with chronic stroke or traumatic amputation it has yet to be evaluated in older Veterans with non-traumatic LLA In contrast error-correction training involves reducing movement errors by overcorrecting for asymmetry Both error-augmentation and error-correction gait training are based upon motor learning principles of distributed practice task specificity and feedback Each of these error-manipulation interventions have potential advantages over traditional gait training following LLA which involves repeated bouts of walking with minimal feedback on movement quality and is often unsupervised Therefore the primary aim of this study is to determine the efficacy of error-manipulation gait training to improve gait symmetry A secondary aim is to evaluate signals of efficacy for improved secondary measures of physical function Lastly this study will explore changes to residual limb skin health and prosthesis socket fit following error-manipulation gait training The unique use of motor learning principles in error-manipulation gait training to improve gait symmetry addresses the problem of chronic gait asymmetry following non-traumatic LLA The results of this study will advance rehabilitation knowledge and provide necessary evidence for the clinical translation of gait training protocols based in motor learning principles for the at-risk population of Veterans with non-traumatic LLA
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?:
False
Is an FDA AA801 Violation?:
None