NCT06259695

Development and Usability of an Adjustable Prosthesis for Aquatic Therapy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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 doesn't 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 (n=3) to quantity the usability of the prosthesis as a therapy tool.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	Adjustable Aquatic Therapy Prosthesis	We will recruit up to three participants, who will attend up to two fitting appointments lasting up to one hour to assist in the design development. After the design of the prosthesis is completed, participants will attend three, 30-minute, aquatic therapy sessions with a physical therapist trained in aquatic therapy and utilize the prosthesis.

Timeline

• Start date: 2023-08-23
• Primary completion: 2025-12-15
• Completion: 2025-12-31
• First posted: 2024-02-14
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States