Clinical trial NCT06259695: Development and Usability of an Adjustable Prosthesis for Aquatic Therapy
Official title: Development and Usability of an Adjustable Prosthesis for Aquatic Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Amputation
Keywords: Aquatic Therapy
Limb Loss
Limb Difference
Prosthesis
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18-89 years
* Patients who have a unilateral transtibial amputation who are able to use a prosthesis
* Patients who currently participate in aquatic therapy at Shirley Ryan AbilityLab, or have completed aquatic therapy within the last six months, at Shirley Ryan AbilityLab

Exclusion Criteria:

* Pregnant women
* Children (\<18 years old)
* Prisoners or institutionalized individuals
* Individuals who have the inability to give informed consent
* Participants with complicating health conditions that interfere with the study
* Participants with contraindications to aquatic therapy, as listed in Shirley Ryan AbilityLab's policy on aquatic therapy participation

Primary outcomes:
measure: System Usability Survey - Subject
timeFrame: Through study completion, an average of one year.
Secondary outcomes:
measure: Socket Comfort Score
timeFrame: Through study completion, an average of one year.
measure: System Usability Survey - Physical Therapist
timeFrame: Through study completion, an average of one year.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan Ability Lab
state: Illinois
Study officials:
References: