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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of prosthetic leg that absorbs shock and may help control skin temperature for people with leg amputations and diabetes. Researchers aim to determine if this design offers advantages over regular prosthetics. Individuals who have lost a leg below the knee, can walk for at least 10 minutes without excessive fatigue, and have had the amputation for at least six months may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative prosthetic advancements that could enhance daily comfort and mobility.

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 prior data suggests that this shock-absorbing prosthesis is safe?

Research shows that users generally receive shock-absorbing prostheses well. A previous study found no safety issues with these prostheses for people with leg amputations. Participants preferred shock-absorbing pylons over traditional stiff ones. These findings suggest that the prostheses are not only safe but also comfortable, especially when walking faster.

Overall, the evidence indicates that shock-absorbing prostheses have a positive safety record, making them a promising choice for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the shock-absorbing prosthesis because it introduces a new way to enhance comfort and mobility for individuals with leg amputations. Unlike traditional rigid pylons, this prosthesis features a compressive "shock-absorbing" pylon that connects the prosthetic foot to the socket. This innovative design aims to reduce the impact and stress on the body during activities like walking or running, potentially leading to a smoother and more comfortable experience for users. By lessening the strain typically felt with standard prosthetics, this treatment could improve long-term joint health and overall quality of life for amputees.

What evidence suggests that the shock-absorbing prosthesis is effective for managing skin temperature in people with amputation and diabetes?

This trial will compare two types of prosthetic pylons for leg amputations: a rigid pylon and a shock-absorbing pylon. Research has shown that prosthetic limbs with shock-absorbing features can make walking more comfortable and reduce pain for people with leg amputations. Studies have found that these prosthetics feel less stiff, decreasing discomfort while walking. Users have reported feeling more comfortable, especially when walking faster. In some studies, the shock-absorbing prosthetic performed as well as a regular one in terms of overall effectiveness. Overall, this evidence suggests that shock-absorbing prosthetics might improve daily comfort and mobility for users. ^{1 3 4 6 7}

Who Is on the Research Team?

Kota Takahashi

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00939-8

Reducing stiffness of shock-absorbing pylon amplifies ... Prior studies have suggested that wearing a prosthesis with a SAP can improve user comfort and reduce residual limb pain compared to walking ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5555034/

SHOCK ABSORPTION DURING TRANSTIBIAL AMPUTEE ... Lower-limb shock-absorbing prosthetic components, including feet, pylons, and gel liners, often serve to reduce prosthesis stiffness. The effects of this ...

3. rehab.research.va.gov rehab.research.va.gov/JOUR/05/42/6/pdf/berge.pdf

Efficacy of shock-absorbing versus rigid pylons for impact ... The results from the laboratory, field, and subjective outcome measurements suggest that the SAP in this study is as effective as a rigid pylon for unilateral ...

4. researchgate.net researchgate.net/publication/8624292_The_effect_of_a_shock-absorbing_pylon_on_the_gait_of_persons_with_unilateral_transtibial_amputation

(PDF) The effect of a shock-absorbing pylon on the gait of ... Prosthetic users also reported improved comfort when using a shockabsorbing pylon, particularly at higher speeds [26, 27]. An additional benefit ...

5. withpower.com withpower.com/trial/shock-absorbing-prosthesis-for-leg-amputation-4c38e

Shock-Absorbing Prosthesis for Leg Amputation Only 36% of geriatric vascular amputees in the community were successfully fitted with prosthetics, highlighting a significant gap compared to the 74% success ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8955603/

Reported Outcome Measures in Studies of Real-World ... Compare Shock-Absorbing Pylons (SAPs) with a conventional rigid pylon, assess effect on gait mechanics, measure transmitted accelerations in situ, and determine ...

7. effectivehealthcare.ahrq.gov effectivehealthcare.ahrq.gov/sites/default/files/pdf/prosthesis-draft-report.pdf

Lower Limb Prosthesis - Effective Health Care Program 61 ambulatory and functional outcomes, and other measures, have been evaluated, of which 19 have been validated and found reliable in studies applicable to the ...