Clinical trials: Transtibial Amputation
Amputation
Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations
Bicycling is a promising form of low-impact exercise that could prevent/treat Type 2 diabetes. However, Veterans with transtibial amputations (TTAs) may not effectively utilize bicycling for rehabilitation and exercise due to…
- Trial name
- BestBikeFit (NCT03828331)
- Testing
- Prosthetic/Bicycle Configuration
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Amputation
Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?
Previous studies suggest that Veterans with below the knee amputation using passive-elastic or powered prostheses have impaired physical function, which could increase the risk of osteoarthritis, leg/back pain, and…
- Trial name
- NCT03974945
- Testing
- Passive-elastic prosthetic foot, Powered ankle-foot prosthesis
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Transtibial Amputation - Unilateral
Comparative Performance of Dynamic Elastic Response Feet
The purpose of this study was to compare the functional performance of individuals with transtibial amputation using two types of prosthetic foot designs: carbon fiber vs. fiberglass composite.
- Trial name
- NCT02542761
- Testing
- Fiberglass Composite foot, Carbon Fiber Composite Foot
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mayo Clinic
Amputation, Elderly
Falls in Older Persons With Limb Loss
Lower limb prosthesis users are known to be at a substantially increased fall risk compared to able-bodied individuals. The interaction between increased fall risk, reduced balance confidence and high prevalence of a fear of…
- Trial name
- FOPLL (NCT03670004)
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Transtibial Amputation
Evaluation of a Modified Running-specific Prosthetic Foot
The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF)…
- Trial name
- NCT02440711
- Testing
- Energy storing foot (ESF), Modified running specific foot (mRSF)
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Washington
Lower Limb Amputation
Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket.
- Trial name
- DoD (NCT03927404)
- Testing
- Active vacuum test prosthesis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Indiana University
Lower Extremity Amputation
Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation
When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available.
- Trial name
- NCT03532100
- Testing
- Torsionally adaptive prosthesis with 0:1 coupling ratio, Torsionally adaptive prosthesis with 1:6 coupling ratio, Torsionally adaptive prosthesis with 1:4 coupling ratio
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- VA Office of Research and Development
Transtibial Amputation
Metabolic Cost Savings for Transtibial Amputees Wearing the Controlled Energy Storage and Return (CESR) Foot
To determine if below-knee amputees will walk with better efficiency wearing a CESR foot which stores energy at heel strike and releases energy releases energy during push-off.
- Trial name
- NCT00494143
- Testing
- CESR Prosthetic Foot, typical prosthetic foot, standardized prosthetic foot
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Amputation
Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
Many service members suffering major limb amputation(s) during active duty seek to return to active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular…
- Trial name
- NCT01404559
- Testing
- Ossur Variflex prosthetic foot, Ossur Ceterus prosthetic foot, Endolite Elite Blade prosthetic foot
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Amputation, Amputation; Traumatic, Leg, Lower
Socket Cooling Effectiveness Take Home Study
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower
- Trial name
- NCT04484805
- Testing
- ICE Condition
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Amputation Stumps
Investigation Into the Functional Performance of a New Thermoplastic Elastomer (TPE) Transtibial Liner
The clinical investigation is designed as an uncontrolled open prospective, multicenter, 2 group, pre-test post-test study. Testing will be conducted in the USA and Canada at 3-6 clinics, depending on enrolment requirements.
- Trial name
- NCT02622919
- Testing
- TPE Liner
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Össur Iceland ehf
Lower Extremity Amputation
Adherence and Perspiration While Wearing Lower Limb Prostheses
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses.
- Trial name
- NCT03900845
- Testing
- Dynamic Air Exchange - Rising Edge Design (DAE-RED), Perforated elastomeric liner, As-prescribed prosthesis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
Transtibial Amputation
Effects of Shrinker Use on Healing and Volume
We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers.
- Trial name
- NCT00693628
- Testing
- compression shrinker
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Oklahoma
Amputation, Limb Deficiencies
Assessing the DSR Ankle
This research is being done to conduct a preliminary investigation into a new prosthetic microprocessor controlled (MPC) ankle, called the Damping, Stiffness, and Repositioning (DSR) ankle.
- Trial name
- NCT05955378
- Testing
- DSR Ankle, Predicate Ankle
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Synchro Motion LLC
Amputation
Agonist-Antagonist Myoneural Interface for Functional Limb Restoration After Transtibial Amputation
This study involves the functional testing of a new lower extremity prosthesis by healthy, active participants with fully healed transtibial (below knee) amputations.
- Trial name
- NCT03913273
- Testing
- AMI transtibial amputation, Standard transtibial amputation
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Massachusetts Institute of Technology
Amputation
Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
iFIT Prosthetics, LLC® created and commercialized a modular, immediate fit, fully adjustable, prosthetic system suitable for mass production using high strength injection molded polymer materials.
- Trial name
- NCT02886936
- Testing
- iFIT Transtibial Prosthesis, iFIT Transfemoral Prosthesis
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- University of Pennsylvania
Amputation, Prosthesis User
Lower Limb Prostheses for Individuals Who Carry Infants, Toddlers, and Other Loads
The aim of this research is to identify the prosthetic foot that results in improved walking performance when individuals with lower limb amputation carry infants, toddlers, or other loads.
- Trial name
- NCT07159490
- Testing
- Standard-of-care prosthetic foot, Standard-of-care prosthetic foot with heel-stiffening wedge, Standard-of-care prosthetic foot of one category greater stiffness
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- VA Puget Sound Health Care System