Clinical trials: Transtibial Amputation
Amputation; Traumatic, Leg, Lower
Transtibial Osseointegration
Purpose: Aim 1: Quantify soft tissue complications and infections of service members with transtibial amputations treated with OPRA OI and compare them to transfemoral OI service members.
- Trial name
- TOSS (NCT06636136)
- Testing
- OPRA
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Walter Reed National Military Medical Center
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
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
Amputation
Socket Geometry and Clinical Outcomes of Manual vs Digital Sockets for Lower-limb Amputees
The most important aspect of a lower-limb prosthesis is the socket as the interface between the human and the mechanical prosthetic system.
- Trial name
- NCT06504303
- Testing
- 3D-printed socket
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- West Park Healthcare Centre
Transtibial Amputee, Transtibial Amputation
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
The investigation is an early feasibility study in up to 5 subjects, in which the primary objective is to capture preliminary safety and effectiveness information on the Magnetic Bead Tracking system.
- Trial name
- NCT07195461
- Testing
- Magnetic Bead Tracking System
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- MuscleMetrix, LLC
Amputation
Reduction of Shear Forces Using Semi-flexible Sockets on Transtibial Amputees
The purpose of this graduate student research study, is to test two different sockets for comfort and test what pressures are created by the socket during daily activities.
- Trial name
- NCT03390153
- Testing
- semi flexible socket, rigid fiber socket
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Loma Linda University
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
Lower Limb Amputation Below Knee (Injury)
The Effects of Small Variations in Shoe Heel Height on Gait in People With a Transtibial Amputation
Prosthetic alignment is important for walking function and walking comfort in people with a transtibial amputation (TTA). Prosthetic alignment is defined as the position of prosthetic parts relative to the body and to each other.
- Trial name
- NCT04641845
- Testing
- Cork inlay wedge
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Sint Maartenskliniek
Amputation, Prosthesis User
Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System
Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.
- Trial name
- NCT05190354
- Testing
- Xtremity Polymer Prosthetic Socket
- Where
- 2 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Medical Creations, Inc.
Transtibial Amputation
Temporary Prosthesis in Traumatic Below-knee Amputation
Most trauma survivors in low-income countries develop post-injury chronic pain syndromes. Normally traumatic amputees have to wait 4-6 months for definitive prosthesis fitting.
- Trial name
- NCT00263497
- Testing
- Temporary tuber-ischii bearing prosthesis
- Where
- Cambodia
- Volunteers
- 20 people
- Sponsor
- University Hospital of North Norway
Lower Limb Amputation
A Pilot RCT to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With Lower Limb Amputation
This is a pilot randomized controlled trial to assess the feasibility of a home-based Nintendo Wii Fit program (Wii.n.Walk) to improve walking capacity in older adults with a lower limb amputation.
- Trial name
- NCT01715662
- Testing
- Wii.n.Walk, Wii Big Brain
- Where
- 3 sites in Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
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
Amputation
1C70 Feasibility Study
The objective of this study is to characterize the extent of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of…
- Trial name
- NCT05628064
- Testing
- 1C70, Pro-Flex XC
- Where
- 6 sites in Germany
- Volunteers
- 22 people
- Sponsor
- Otto Bock Healthcare Products GmbH
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
A Stabilized Definitive Prosthesis (Procedure 1), Definitive Prosthesis With a Contact Socket (Procedure 1)
Contribution of Near-InfraRed Spectroscopy (NIRS) to the Evaluation of Healing After Amputation of the Leg
50 patients will be included for each of the 2 procedures: For procedure 1: Patients will be selected during multidisciplinary consultations for amputees who are stabilized with their definitive prosthesis and have returned to…
- Conditions
- A Stabilized Definitive Prosthesis (Procedure 1), Definitive Prosthesis With a Contact Socket (Procedure 1), Patients in the Initial Phase (Temporary Prosthesis, Rehabilitation) Following Unilateral Post- Transtibial Amputation (Procedure 2)
- Trial name
- NIRS (NCT02551484)
- Testing
- Measurements using NIRS, TCPO2 measurements, 2-minute walk test
- Where
- France
- Volunteers
- 62 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Amputation of Lower Limb Above Knee, Sequelae
Effect of Eight-week Concurrent Training on Functional Capacity in Patients With Unilateral Transtibial Amputation
OBJECTIVES: To assess the effect of concurrent training (CT) of an eight-week on strength, power and cardiorespiratory fitness on muscle condition, balance, load distribution in the lower limbs and aerobic capacity in patients…
- Trial name
- NCT04165434
- Testing
- Concurrent Training
- Where
- Brazil
- Volunteers
- 26 people
- Sponsor
- University of Sao Paulo General Hospital
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
Transtibial Amputation, Prosthetic
Feasibility Study on Using Smart Templates, That Link Rectification Approaches to Particular Patient Characteristics, for Transtibial Prosthetic Socket Fitting
Prosthetic socket comfort and fit is important in ensuring individuals with amputation can get the most use from their prosthetic limb.
- Trial name
- NCT06597266
- Testing
- Smart template - designed prosthetic check socket, Clinician-designed prosthetic check socket
- Where
- 3 sites in United Kingdom
- Volunteers
- 17 people
- Sponsor
- University of Southampton
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 Balance Prosthesis
The Effect of Alternative Prosthetic Alignments on Sit-to-Stand Proficiency in Transtibial Amputees
The purpose of this graduate student research study is to determine the effect of various linear and angular prosthetic alignments on K1-K3 unilateral or bilateral TT amputees, as well as test for proficiency, comfort, balance…
- Trial name
- NCT04657614
- Testing
- Neutral Alignment, Anterior Alignment, Posterior Alignment
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Loma Linda University