Clinical trials: Transtibial Amputation
Transtibial Amputation, Lower Limb Amputation
Impact of Footwear on Gait in Unilateral Transtibial Amputees
The goal of this interventional study is to learn how different types of footwear affect gait, stability, comfort, and walking performance in adults with a unilateral transtibial amputation who use a lower limb prosthesis.
- Conditions
- Transtibial Amputation, Lower Limb Amputation, Prosthesis Users
- Trial name
- NCT07685496
- Testing
- Own Footwear, Oxford Shoe, Walking/Running Shoe
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- University of Salford
Amputation, Transtibial Amputation - Unilateral
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic…
- Conditions
- Amputation, Transtibial Amputation - Unilateral, Bone Anchored Devices, Osseointegration
- Trial name
- TBAL (NCT07263945)
- Testing
- As-prescribed prosthetic foot stiffness, A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot, A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Colorado, Denver
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
Transtibial Amputation - Unilateral
Comparison of Various Prosthetic Foot-Ankle Mechanisms
In summary, subjects will be asked to wear a number of sensors and use different ankle-foot prostheses in place of their customary prosthesis.
- Trial name
- NCT05964855
- Testing
- MIT Variable Stiffness Prosthesis v1, MIT Variable Equilibrium Angle Prosthesis v1, MIT Sliding Beam Passive Prosthesis
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Massachusetts Institute of Technology
Transtibial Amputation - Unilateral, Transtibial Amputation
Motor Imagery for Prosthetic Gait Training in Transtibial Amputees
This study included the development of motor imagery (i.e., the cognitive process of mentally reheasing a motor task) protocol for improving prosthetic gait among acute transtibial amputees.
- Conditions
- Transtibial Amputation - Unilateral, Transtibial Amputation, Transtibial Amputee
- Trial name
- NCT07652619
- Testing
- Motor Imagery
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Ariel University
Transtibial Amputation
Transtibial Amputation Outcomes Study
The goals of the TAOS study is to determine the best procedures for below the knee amputations. There are two different procedures currently used by surgeons around the county: the Erlt procedure and the Burgess procedure.
- Trial name
- TAOS (NCT01821976)
- Testing
- Ertl Procedure, Burgess Procedure
- Where
- 23 sites in United States
- Volunteers
- 199 people
- Sponsor
- Major Extremity Trauma Research Consortium
Transtibial Amputation, Lower Limb Amputation Below Knee
Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis
Transtibial amputation significantly impacts patient autonomy and quality of life, primarily due to the limitations of conventional rigid sockets, which restrict comfort and joint range of motion.
- Trial name
- AS-TT (NCT07592325)
- Testing
- Access Socket (AS), Rigid Socket (RS)
- Where
- 5 sites in France
- Volunteers
- 25 people
- Sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Transtibial Amputation, Transfemoral Amputation
Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket.
- Trial name
- SocketFit (NCT05989243)
- Testing
- Conventional prosthetic socket, Adjustable Quatro socket
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Transtibial Amputation, Peripheral Artery Disease
Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation
The population of older Veterans with non-traumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary…
- Conditions
- Transtibial Amputation, Peripheral Artery Disease, Diabetes Mellitus
- Trial name
- GEM (NCT03995238)
- Testing
- Error-augmentation gait training, Error-correction gait training, Supervised walking
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- VA Office of Research and Development
Transtibial Amputation - Unilateral
Socket-leg Interface Movements in Transtibial Amputees
This exploratory interventional study investigates dynamic prosthetic fit in unilateral transtibial prosthesis users by objectively measuring socket-leg interface movements (SLMs) during functional activities.
- Trial name
- SLMinTTA (NCT07521891)
- Testing
- Pin-Lock Suspension System, Passive Vacuum Suspension System, Active Vacuum Suspension System
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- Norwegian University of Science and Technology
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
Transtibial Amputation - Unilateral, Lower Limb Amputation Below Knee
Prosthetic Satisfaction, Body Image, and ICF Outcomes After Amputation
Lower limb amputation affects not only physical mobility but also psychological well-being, body perception, and involvement in daily and social life.
- Conditions
- Transtibial Amputation - Unilateral, Lower Limb Amputation Below Knee, Body Image, Activities of Daily Living
- Trial name
- ICF (NCT07385859)
- Testing
- No intervention (observational study)
- Where
- Turkey (Türkiye)
- Volunteers
- 27 people
- Sponsor
- Ondokuz Mayıs University
Transtibial Amputation
Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
The goal of this clinical trial is to 1) demonstrate the feasibility of monitoring pressure, temperature, and lactic acid density of sweat inside the prosthetic socket, and 2) verify the relationship between mechanical pressure…
- Trial name
- NCT07216183
- Testing
- Walk, Yuga post, E-SWEAT Sensor
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- North Carolina State University
Amputation, Transtibial Amputation - Unilateral
The Relationship of Quadriceps and Hamstring Strength on Timed up and go Scores in Transtibial Amputees
To investigate the correlation between the effect of quadriceps and hamstring strength on timed up and go scores in adults with tarns - tibial amputation
- Conditions
- Amputation, Transtibial Amputation - Unilateral, Quadriceps Muscle Strength, Hamstring Muscle Strength
- Trial name
- NCT07067203
- Testing
- Lafayette hand held dynamometer, Timed up and Go test
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Cairo 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 - Unilateral
Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees
This study aimed to investigate the experience and satisfaction of unilateral transtibial amputees with prostheses. This study included 31 unilateral transtibial amputees aged 18-75 years.
- Trial name
- NCT06599060
- Testing
- Trinity Amputation and Prosthesis Experience Scale
- Where
- Turkey (Türkiye)
- Volunteers
- 31 people
- Sponsor
- Medipol University
Transtibial Amputation, Artificial Limbs
Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP
The purpose of this research is to validate the e-MIP design and function by testing the ability of e-MIP to harvest energy and return a sufficient amount of energy to assist the user during gait.
- Trial name
- NCT04157608
- Testing
- Habitual Prosthesis, Energy-Harvesting Mesofluidic Impulse Prosthesis
- Where
- United States
- Sponsor
- Orthocare Innovations, LLC
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
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
Transtibial Amputation
Virtual Reality Rehabilitation for Individuals With Lower Limb Amputation
A custom designed Virtual Gait Retraining System (VGRS) is being adapted for balance and mobility rehabilitation in individuals with transtibial amputation.
- Trial name
- NCT02328859
- Testing
- Virtual Reality Gait Training, Treadmill Gait Training
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- VA Office of Research and Development