Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-02
Brief Title:
Prosthetic Performance Enhancement Trial
Sponsor:
University of Nevada Las Vegas
Organization:
University of Nevada Las Vegas
Study Overview
Official Title:
Prosthetic Performance Enhancement Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
PROSPER
Brief Summary:
The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users The training is designed to induce step-to-step variability during walking within a safe environment with the aim of improving walking skill and confidence
Detailed Description:
Despite advances in the technology for artificial limbs prostheses falling and the fear of falling continue to be barriers to mobility for many lower limb prosthesis users after their initial rehabilitation The loss of ability and confidence in pursuing everyday tasks negatively impacts quality of life and ongoing physical and mental health This study will test and improve a rehabilitation training intervention involving walking on uneven ground to improve walking skill and confidence in lower limb prosthesis users
Lower limb prosthesis users will be recruited Participants will be allocated randomly to receive either intervention A training on a flat surface or intervention B training on an uneven surface Depending on their ability and confidence participants will complete the walking practice either on a treadmill or on a mat with an identical surface pattern The walking practice will take place three times per week for four weeks As each participant improves their ability training tasks will be made more difficult by limiting handrail use by increasing walking speed and for intervention B also by making the walking surface more uneven
The objectives of this pilot study are to evaluate adherence and refine the training protocols in preparation for a definitive trial that will inform rehabilitation practices
Lower limb prosthesis users will be recruited Participants will be allocated randomly to receive either intervention A training on a flat surface or intervention B training on an uneven surface Depending on their ability and confidence participants will complete the walking practice either on a treadmill or on a mat with an identical surface pattern The walking practice will take place three times per week for four weeks As each participant improves their ability training tasks will be made more difficult by limiting handrail use by increasing walking speed and for intervention B also by making the walking surface more uneven
The objectives of this pilot study are to evaluate adherence and refine the training protocols in preparation for a definitive trial that will inform rehabilitation practices
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