Adjustable Prosthesis for Aquatic Therapy After Amputation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Pregnancy, Children, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new prosthesis designed for use in the pool, helping people with limb loss during aquatic therapy. The goal is to create an adjustable, water-friendly prosthetic leg that fits various limb shapes and sizes, making therapy more accessible and effective. It is ideal for those with a below-knee amputation who are currently or have recently engaged in aquatic therapy at Shirley Ryan AbilityLab. The prosthesis promises a comfortable fit, safe movement in water, and added confidence for patients. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions in aquatic therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this prosthesis is safe for aquatic therapy?

Research shows that the adjustable aquatic therapy prosthesis prioritizes safety. It uses waterproof materials and maintains balance to help users stay stable in water. The prosthesis adjusts to fit various limb shapes and sizes, ensuring a secure and comfortable fit.

Studies also highlight the prosthesis's soft layer, which protects the skin. To ensure safety, clinical staff check the skin before and after each use and assist during fitting and use, reducing risks.

Although specific safety data from existing studies is limited, these design features aim to provide a safe experience for users during aquatic therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Adjustable Aquatic Therapy Prosthesis because it offers a unique level of adaptability that current prostheses lack. Unlike standard prosthetic limbs, this innovative device can be adjusted in circumference, limb length, and height, making it versatile enough to fit a wide range of limb shapes. Additionally, it provides secure suspension for both land and aquatic activities, maximizing safety and comfort. This design not only ensures a snug fit to protect the skin but also effectively translates movement from the residual limb to the prosthesis, potentially enhancing therapy outcomes.

What evidence suggests that this prosthesis is effective for aquatic therapy?

Research shows that the Adjustable Aquatic Therapy Prosthesis, used by participants in this trial, holds promise for water-based rehabilitation. Early studies found that participants rated it highly for ease of use in aquatic therapy. The prosthesis fits comfortably and securely, enhancing the safety and effectiveness of water exercises for individuals with limb loss. Its adjustable size accommodates a wide range of users. This prosthesis aims to make aquatic therapy more affordable and accessible by providing a water-specific option often not covered by insurance. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with limb loss who could benefit from aquatic therapy but don't have a prosthesis for use in water. The study aims to provide an adjustable, cost-effective prosthetic suitable for various patients to improve their rehabilitation experience.

Inclusion Criteria

Patients who have a unilateral transtibial amputation who are able to use a prosthesis

I am currently in or recently finished aquatic therapy at Shirley Ryan AbilityLab.

Exclusion Criteria

Pregnant women

I am under 18 years old.

Prisoners or institutionalized individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Fitting

Creation and initial fitting of the adjustable prosthesis for aquatic therapy

4-8 weeks

Multiple visits for fitting and adjustments

Pilot Study

Participants use the prosthesis in aquatic therapy sessions to evaluate usability

12 months

Regular therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after using the prosthesis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adjustable Aquatic Therapy Prosthesis

Trial Overview The focus of the trial is on a new type of prosthesis designed specifically for aquatic therapy. It's adjustable in size and shape to fit different users. The goal is to see if it can help make rehab exercises easier and more accessible in the pool.

How Is the Trial Designed?

Group I: Adjustable Aquatic Therapy Prosthesis Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

Lower extremity amputees have significant potential for lifestyle recovery through the use of adaptive prosthetics, which can greatly enhance their mobility and quality of life.

The initial prosthetic prescription from a physician is crucial, as it determines the type of prosthetics available to the patient, impacting their ability to engage in desired activities and promoting a positive mental attitude during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive prosthetics for the lower extremity. Carroll, K.[2022]

New prosthetic designs and advanced rehabilitation programs are now tailored to meet the fitness and performance needs of active amputees, allowing them to engage in a variety of sports and activities.

Collaboration among surgeons, prosthetists, and trainers has significantly improved the functionality of prostheses, enabling amputees to compete successfully in sports, highlighting a shift in focus from merely adapting to thriving with prosthetic technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in recreational prostheses and adaptive devices for the amputee. Michael, JW., Gailey, RS., Bowker, JH.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12189191/

Development and Usability of an Adjustable Prosthesis ... The System Usability Scale indicated that the prosthesis was usable for aquatic therapy. Participant scores were 97.5, 95, and 87.5, and ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06259695

Development and Usability of an Adjustable Prosthesis for ... 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 ...

3. sralab.org sralab.org/articles/blog/creating-adjustable-prosthesis-aquatic-therapy

Creating an Adjustable Prosthesis for Aquatic Therapy To quantify the experience, the research team collected survey data from those who tried out the prototype — and early results were promising.

4. colab.ws colab.ws/articles/10.1097%2Fjpo.0000000000000544

Development and Usability of an Adjustable Prosthesis for ... The System Usability Scale indicated that the prosthesis was usable for aquatic therapy. Participant scores were 97.5, 95, and 87.5, and ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31951260/

Effectiveness of an Evidence-Based Amputee ... Results: The intervention group improved on the AMPPro scores (36.4 to 41.7), AMPnoro scores (23.2 to 27.1), and 6MWT distance (313.6 to 387.7 m) ...

6. journals.lww.com journals.lww.com/jpojournal/fulltext/2025/07000/development_and_usability_of_an_adjustable.10.aspx

Development and Usability of an Adjustable Prosthesis for... This study explores the development and usability of an adjustable prosthesis, utilizing dilatancy, for aquatic therapy.

7. physio-pedia.com physio-pedia.com/Hydrotherapy_Risk_Management

Hydrotherapy Risk Management Working in water is potentially hazardous for both patients and physiotherapy staff. Hazards include: Drowning; Heat Exhaustion