Development and Usability of an Adjustable Prosthesis for Aquatic Therapy

NCT06259695 | Active Not Recruiting

• 1 other identifier: STU00219525
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

Aquatic Therapy; Limb Loss; Limb Difference; Prosthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Socket Comfort Score

  Through study completion, an average of one year.

• System Usability Survey - Physical Therapist

  Through study completion, an average of one year.

Study Arms (1)

Adjustable Aquatic Therapy Prosthesis

EXPERIMENTAL

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

Interventions

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.

Adjustable Aquatic Therapy Prosthesis

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan Ability Lab

Chicago, Illinois, 60611, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Team Scientist II

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 14, 2024
• Study Start: August 23, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)