Prosthetic Foot Stiffness for Transtibial Amputation
(TBAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how varying levels of stiffness in a prosthetic foot affect daily life for individuals with below-the-knee amputations who use either bone-anchored or standard socket prosthetics. Researchers aim to understand how foot stiffness impacts movement, comfort, and the risk of falling. Participants will test prosthetic feet that are stiffer and softer than their usual ones, as well as their current prosthetic, to determine the best fit. This trial suits individuals who have had a transtibial amputation, do not regularly use a walking aid, and can walk unassisted for five minutes. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to explore new prosthetic options.
Do I need to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this prosthetic foot stiffness variation is safe for individuals with transtibial amputation?
Research shows that changing the stiffness of a prosthetic foot can affect how people walk and maintain balance. Studies have examined how different stiffness levels influence stability and joint movement. Most results suggest that users can adjust to these changes without major problems. For instance, one study found that prosthetic users could handle different foot stiffness levels when walking on uneven ground. Another study indicated that users had personal preferences for stiffness levels, which varied from person to person, but did not report any serious safety issues.
Regarding safety concerns, little evidence suggests significant problems related to different prosthetic foot stiffness levels. This trial is in its early stages (Phase 1), focusing on assessing safety. At this point, researchers usually test the treatment in small groups to see how well participants handle it. While more research is needed to confirm long-term safety, initial findings suggest that varying prosthetic foot stiffness is generally well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about the trial on prosthetic foot stiffness for transtibial amputation because it explores how different levels of stiffness in prosthetic feet affect comfort and mobility for users. Unlike the standard approach, which typically sticks to a single, prescribed stiffness level, this trial tests prosthetic feet that are both stiffer and softer than what's usually prescribed. By doing so, it aims to uncover the optimal stiffness for better balance and ease of movement, potentially leading to more personalized and effective prosthetic solutions.
What evidence suggests that varying prosthetic foot stiffness could be effective for individuals with transtibial amputation?
This trial will compare different prosthetic foot stiffness levels for individuals with transtibial amputation. Research has shown that altering prosthetic foot stiffness can significantly affect walking and balance in those with below-the-knee amputation. One study found that users can detect even small changes in stiffness, impacting their stability and comfort. Another study demonstrated that adjusting stiffness alters foot and ankle movement, promoting smoother walking. Additionally, a prosthetic foot with adjustable stiffness improved body movement during use. These findings suggest that fine-tuning prosthetic foot stiffness could enhance safety and comfort by reducing fall risk.678910
Are You a Good Fit for This Trial?
This trial is for individuals with transtibial amputation who use a bone-anchored limb or standard socket prosthesis. Participants should be willing to test different prosthetic foot stiffness levels during daily activities.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants perform activities of daily living with varying prosthetic foot stiffness categories to assess clinical and biomechanical outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Prosthetic Foot Stiffness Variation
Trial Overview
The study tests how changing the stiffness of a prosthetic foot affects bone-implant loading, function, pain, biomechanics, osseoperception (bone sensation), and fall risk. It's a cross-over design where participants will try feet that are softer and stiffer than their usual ones.
How Is the Trial Designed?
3
Treatment groups
Active Control
A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot. The prosthetic foot type, including the manufacturer and length, will remain the same as the nominal (as-currently prescribed) foot.
A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot. The prosthetic foot type, including the manufacturer and length, will remain the same as the nominal foot.
The prosthetic foot that is currently prescribed and used by each participant daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
The effect of prosthetic foot stiffness category on intact limb ...
This study aimed to isolate the effect of commercial prosthetic foot stiffness on intact knee loading, prosthetic foot-ankle biomechanics, and user perception.
The effect of prosthetic foot stiffness on foot-ankle ...
The aim of this study was to determine the effect of commercial prosthetic foot stiffness category on foot-ankle biomechanics, gait symmetry, community ...
Assessing the effects of prosthetic foot stiffness and foot ...
Therefore, this study aims to determine 1) the effects of prosthetic foot stiffness on stability in lower limb prosthesis users while walking on varying ...
Variable-stiffness prosthesis improves biomechanics of ...
This paper presents clinical results from a study with 7 participants with unilateral transtibial amputation. We show that a microprocessor- ...
5.
jneuroengrehab.biomedcentral.com
jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-018-0432-5Amputee perception of prosthetic ankle stiffness during ...
Below-knee amputees were able to sense a 7.7% difference in prosthetic ankle stiffness, and demonstrated high repeatability in selecting their ...
Assessing the effects of prosthetic foot stiffness and foot ...
Therefore, this study aims to determine 1) the effects of prosthetic foot stiffness on stability in lower limb prosthesis users while walking on ...
Effects of prosthetic ankle stiffness on adaptation to uneven ...
This study evaluated the interactions between prosthesis stiffness and walking surface height variability on step characteristics and joint mechanics.
Study Details | Personalized Prosthetic Foot Prescription ...
Assess the effect of prosthetic foot selection based on experiential preference as determined using a variable stiffness foot on mobility and satisfaction ...
Comparing preference of ankle–foot stiffness in below- ...
On average, prosthetist subjects preferred a 26% higher stiffness than amputee subjects (p < 0.001), though this depended on the amputee subject (p < 0.001).
The effect of prosthetic foot stiffness on foot-ankle ...
The aim of this study was to determine the effect of commercial prosthetic foot stiffness category on foot-ankle biomechanics, gait symmetry, community ...
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