Development and Usability of an Adjustable Prosthesis for Aquatic Therapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Amputation
• Intervention / Treatment: Device: Adjustable Aquatic Therapy 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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan Ability Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Adjustable Aquatic Therapy Prosthesis; The prosthesis will be designed to be adjustable in circumference, residual limb length, and overall height. This will allow adjustability to accommodate most limb shapes. The design will also provide secure suspension, on both land and in the water. This will maximize safety for the patient and translate motion from the residual limb to the prosthesis. Additionally, the prosthesis design will include a comfortable fit and interface, protecting the participant's skin. Skin will be assessed prior to use, during initial fitting, and after each therapy session. Finally, the prosthesis will be test fit and used with maximum assistance from clinical staff, minimizing risk.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Survey - Subject	The System Usability Survey is a reliable tool for measuring the usability of a device. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.	Through study completion, an average of one year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socket Comfort Score	Rating system to assess prosthesis socket comfort. Scale ranges from 0-10, with 0 being the least comfortable and 10 the most comfortable.	Through study completion, an average of one year.
System Usability Survey - Physical Therapist	The System Usability Survey is a reliable tool for measuring the usability of a device. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.	Through study completion, an average of one year.

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Prosthesis; Limb Loss; Aquatic Therapy; Limb Difference
• Other Study ID Numbers: STU00219525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No