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

3 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Adjustable Aquatic Therapy Prosthesis treatment?

Research on Water Activity Limbs (WALs) shows that they are recommended for specific water sports and activities, indicating that specialized prosthetics can be effective for aquatic therapy. Additionally, early aquatic physical therapy has been found to improve function without increasing wound-related risks, suggesting that water-based rehabilitation can be beneficial for recovery. ^{1 2 3 4 5}

Is the Adjustable Prosthesis for Aquatic Therapy safe for humans?

There is no specific safety data available for the Adjustable Prosthesis for Aquatic Therapy, but a study on early aquatic physical therapy after orthopedic surgery found it to be low-risk and not increasing wound-related adverse events, suggesting aquatic therapy in general is safe. ^{1 2 6 7 8}

How does the Adjustable Aquatic Therapy Prosthesis differ from other treatments for amputees?

The Adjustable Aquatic Therapy Prosthesis is unique because it is specifically designed for use in water, allowing amputees to participate in aquatic therapy and water sports. Unlike standard prostheses, it is water-resistant and adjustable, catering to the specific needs of swimming and other water activities, which can enhance both physical and psychological well-being. ^{1 3 9 10 11}

Eligibility Criteria

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

I am between 18 and 89 years old.

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

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

Exclusion Criteria

Pregnant women

I am under 18 years old.

Prisoners or institutionalized individuals

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Water activity limbs. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Early aquatic physical therapy improves function and does not increase risk of wound-related adverse events for adults after orthopedic surgery: a systematic review and meta-analysis. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Adaptive prosthetics for the lower extremity. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Psychosocial and physical adjustments and prosthesis satisfaction in amputees: a systematic review of observational studies. [2021]

5. France pubmed.ncbi.nlm.nih.gov

Use of the Femurett adjustable prosthesis in the assessment and walking training of new above-knee amputees. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The kinematics of paretic lower limb in aquatic gait with equipment in people with post-stroke hemiparesis. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Activity-specific aquatic therapy targeting gait for a patient with incomplete spinal cord injury. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Reliability of Measuring Leg Segments and Joint Angles Using Smartphones during Aquatic Exercise. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Devices to enable persons with amputation to participate in sports. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

New developments in recreational prostheses and adaptive devices for the amputee. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Recreational activities of lower extremity amputees: a survey. [2015]