Shock-Absorbing Prosthesis for Leg Amputation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Stroke, Parkinson's, Multiple sclerosis, others

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

Compensation: Varies

Number of Visits: 10

Duration: 10 visits

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this project is to understand the factors that affect skin temperature (e.g., tissue above amputation site, and opposite foot) in people with amputation and diabetes. This project will also test the effects of 'shock-absorbing' prosthesis on skin temperature responses.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Shock-absorbing Prosthesis for leg amputation?

Research shows that shock-absorbing prostheses may provide comfort benefits for people with leg amputations, especially when walking at higher speeds, although they do not significantly change walking mechanics compared to rigid prostheses. ^{1 2 3 4 5}

Is the shock-absorbing prosthesis safe for humans?

The studies reviewed did not report any safety concerns for shock-absorbing prostheses in people with leg amputations, and participants generally preferred them for comfort during walking. ^{1 2 3 6 7}

How is the shock-absorbing prosthesis treatment different from other treatments for leg amputation?

The shock-absorbing prosthesis is unique because it includes a component called a shock-absorbing pylon, which helps reduce the impact forces when walking or running, making it more comfortable for users, especially at higher speeds. This feature is not typically found in standard prosthetic limbs, which may not provide the same level of shock absorption. ^{1 6 8 9 10}

Research Team

Kota Takahashi

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for individuals with an amputation and diabetes, focusing on how their skin temperature changes. Details about who can join or reasons why someone might not be able to participate are not provided.

Inclusion Criteria

I can walk for 10 minutes without feeling overly tired.

I have one leg amputated below the knee.

I can walk over curbs, stairs, or uneven surfaces without help.

Exclusion Criteria

I have a condition like stroke or Parkinson's that affects my ability to walk.

I have a history of inflammatory diseases like Raynaud's or rheumatoid arthritis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will use two sets of prostheses (with and without shock-absorbing pylon) and undergo various walking tasks to study temperature and vascular responses.

10 visits

Up to 10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Shock-absorbing Prosthesis

Trial Overview The study investigates the impact of a 'shock-absorbing' prosthesis on skin temperature in people with an amputation and diabetes, aiming to understand thermoregulation above the site of amputation and on the opposite foot.

Participant Groups

Group I: Shock-absorbing Pylon Experimental Treatment 1 Intervention

The prosthesis will be given a commercial prosthetic foot and a compressive 'shock-absorbing' pylon that connects the prosthetic foot to the socket.

Group II: Rigid Pylon Experimental Treatment 1 Intervention

The prosthesis will be given a commercial prosthetic foot and a rigid pylon that connects the prosthetic foot to the socket.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

Only 36% of geriatric vascular amputees in the community were successfully fitted with prosthetics, highlighting a significant gap compared to the 74% success rate in specialized Amputee Clinics.

Factors such as increased age, cerebrovascular disease, dementia, and higher amputation levels (above knee) were strong predictors of failure to achieve a successful prosthetic fit, suggesting that careful patient selection and counseling are crucial for improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of the geriatric vascular amputee patient: a population-based study. Fletcher, DD., Andrews, KL., Butters, MA., et al.[2022]

This study improves a numerical model that connects stump stresses to prosthesis loads for below-knee amputees by incorporating actual stump parameters, enhancing the understanding of how these factors interact.

The research reveals how the resistive moment of the stump balances with the prosthesis's flexion-extension moment, providing insights into the maximum normal stresses experienced during specific phases of walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-order model for the analysis of stump stresses for below-knee amputees. Winarski, DJ., Pearson, JR.[2019]

References

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

The effect of a shock-absorbing pylon on the gait of persons with unilateral transtibial amputation. [2019]

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

Efficacy of shock-absorbing versus rigid pylons for impact reduction in transtibial amputees based on laboratory, field, and outcome metrics. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Effect of a shock-absorbing pylon on transmission of heel strike forces during the gait of people with unilateral trans-tibial amputations: a pilot study. [2022]

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

Long-term outcomes following lower extremity press-fit bone-anchored prosthesis surgery: a 5-year longitudinal study protocol. [2023]

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

Rehabilitation of the geriatric vascular amputee patient: a population-based study. [2022]

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

Mechanical properties of shock-absorbing pylons used in transtibial prostheses. [2019]

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

First-order model for the analysis of stump stresses for below-knee amputees. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Prosthetic management of amputees]. [2022]

9. France pubmed.ncbi.nlm.nih.gov

A systematic review of shock-attenuating componentry for lower limb amputees. [2018]

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

Articulated cadaveric bones as a structural endoskeleton in an ankle-foot prosthesis: a preliminary report. [2019]