Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759014
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2021-02-13
Brief Title:
The Effect of Using Two Different Prosthetic Feet in Patients With Unilateral Transtibial Amputation
Sponsor:
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Organization:
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study Overview
Official Title:
The Effect of Using Two Different Prosthetic Feet on Functional Capacity Pain Severity Satisfaction Level and Quality of Life in High Activity Patients With Unilateral Transtibial Amputation
Status:
COMPLETED
Status Verified Date:
2021-11
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:
Background Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data
Aim To investigate the effect of using non-articulated dynamic foot non-articulating ankle NAA and dynamic foot with hydraulic ankle articulating hydraulic ankle AHA on functional capacity pain severity satisfaction level and quality of life QoL in high activity patients with unilateral transtibial amputation
Aim To investigate the effect of using non-articulated dynamic foot non-articulating ankle NAA and dynamic foot with hydraulic ankle articulating hydraulic ankle AHA on functional capacity pain severity satisfaction level and quality of life QoL in high activity patients with unilateral transtibial amputation
Detailed Description:
Background Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data
Aim To investigate the effect of using non-articulated dynamic foot non-articulating ankle NAA and dynamic foot with hydraulic ankle articulating hydraulic ankle AHA on functional capacity pain severity satisfaction level and quality of life QoL in high activity patients with unilateral transtibial amputation
Methods Forty-two patients with unilateral transtibial traumatic amputation will be participated in this cross-sectional study Functional capacity will be evaluated using the six-minute walking test 6MWT The severity of residual limb pain sound limb pain and low back pain will be evaluated with a 10-point Visual Analogue Scale VAS The socket system prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS The QoL of each patient will be assessed using the Short Form 36 SF-36
Aim To investigate the effect of using non-articulated dynamic foot non-articulating ankle NAA and dynamic foot with hydraulic ankle articulating hydraulic ankle AHA on functional capacity pain severity satisfaction level and quality of life QoL in high activity patients with unilateral transtibial amputation
Methods Forty-two patients with unilateral transtibial traumatic amputation will be participated in this cross-sectional study Functional capacity will be evaluated using the six-minute walking test 6MWT The severity of residual limb pain sound limb pain and low back pain will be evaluated with a 10-point Visual Analogue Scale VAS The socket system prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS The QoL of each patient will be assessed using the Short Form 36 SF-36
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