Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06259695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-30
Brief Title:
Development and Usability of an Adjustable Prosthesis for Aquatic Therapy
Sponsor:
Shirley Ryan AbilityLab
Organization:
Shirley Ryan AbilityLab
Study Overview
Official Title:
Development and Usability of an Adjustable Prosthesis for Aquatic Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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 initial purpose of this study is to develop a prosthesis which is adjustable to use with a variety of patients in aquatic therapy Aquatic therapy is a beneficial rehabilitation tool for individuals with limb loss The pool environment offloads body weight which can improve comfort on a residual limb and increase confidence in activities outside of the pool The properties of water also assist in strengthening exercises and reducing pain
Currently most individuals do not have a prosthesis to use in the pool Water specific prosthesis are often not covered by insurance and can be expensive For someone that doesnt have a water specific prosthesis they may not be able to do therapy tasks on two legs limiting what activities or exercises can be performed Through creating an adjustable prosthesis it will allow persons with limb loss to have access to a water specific leg in a time efficient cost effective and safe manner for rehabilitation
This study involves a novel prosthesis for use in aquatic therapy This novel design will have an adjustable circumference residual limb length and height allowing a greater number of patients to use the prosthesis
Currently most individuals do not have a prosthesis to use in the pool Water specific prosthesis are often not covered by insurance and can be expensive For someone that doesnt have a water specific prosthesis they may not be able to do therapy tasks on two legs limiting what activities or exercises can be performed Through creating an adjustable prosthesis it will allow persons with limb loss to have access to a water specific leg in a time efficient cost effective and safe manner for rehabilitation
This study involves a novel prosthesis for use in aquatic therapy This novel design will have an adjustable circumference residual limb length and height allowing a greater number of patients to use the prosthesis
Detailed Description:
The goal of this project is to create and conduct a preliminary usability evaluation of a novel adjustable prosthesis for use in aquatic therapy for persons with a lower limb amputation at the transtibial level LLTTA It is hypothesized that this prosthesis will benefit both the patient and the therapist during aquatic therapy sessions which will be evaluated through the following aims
Aim 1 Create a non-custom adjustable prosthesis for use in aquatic therapy by individuals with limb loss at the transtibial level
Aim 2 Perform a pilot study n3 to quantity the usability of the prosthesis as a therapy tool
Aim 1 Create a non-custom adjustable prosthesis for use in aquatic therapy by individuals with limb loss at the transtibial level
Aim 2 Perform a pilot study n3 to quantity the usability of the prosthesis as a therapy tool
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