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NCT Number: NCT06259695

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Amputation

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan Ability Lab

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adjustable Aquatic Therapy Prosthesis

Device

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.

Primary outcomes

  1. System Usability Survey - Subject

    Time frame: Through study completion, an average of one year.

    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.

Secondary outcomes

  1. Socket Comfort Score

    Time frame: Through study completion, an average of one year.

    Rating system to assess prosthesis socket comfort. Scale ranges from 0-10, with 0 being the least comfortable and 10 the most comfortable.

  2. System Usability Survey - Physical Therapist

    Time frame: Through study completion, an average of one year.

    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.

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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