Clinical trials: Transtibial Amputees
Amputation; Traumatic, Limb, Postural; Defect
Comparison of Transtibial and Transfemoral Amputees' Posture Parameters
With the onset of prosthesis use following lower extremity amputations, body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side.
- Trial name
- NCT04456244
- Testing
- Evaluation of the static posture
- Where
- Turkey (Türkiye)
- Volunteers
- 29 people
- Sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Amputation, Prosthesis User
Sagittal Knee Kinematics of Transtibial Amputee with Running Blade
Introduction: People with transtibial amputation often suffer musculoskeletal deformities in the form of knee osteoarthritis or osteophytosis due to asymmetric movement patterns and often complain of associated symptoms.
- Trial name
- NCT06586762
- Where
- Turkey (Türkiye)
- Volunteers
- 14 people
- Sponsor
- Baskent University
Amputation of Lower Limb, Prosthesis
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling…
- Conditions
- Amputation of Lower Limb, Prosthesis, Non-inferiority Trial of Prothesis
- Trial name
- NCT06648798
- Testing
- Limber Limb
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- LIMBER Prosthetics & Orthotics Inc
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
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, Prosthesis User
Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities
The goal of this observational study is to evaluate and compare the performance of two prosthetic feet for unilateral transtibial amputees during both indoor and outdoor activities.
- Trial name
- NCT06390033
- Testing
- Prosthetic foot
- Where
- Hong Kong
- Volunteers
- 6 people
- Sponsor
- The Hong Kong Polytechnic University
Traumatic Amputation of Lower Extremity
A Comparison of External Mechanical Work Between Different Prosthetic Feet
Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are at risk of functional decline, joint degeneration, skin breakdown and further limb loss due to the forces placed on the contralateral…
- Trial name
- SEW (NCT01340807)
- Testing
- Specialized Functional Prosthetic Training
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Miami VA Healthcare System
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
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
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 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
Transtibial Amputee, Loading
The Effect of Different Measurement-manufacturing Techniques on Load Distribution in Amputees
Alignment of the prosthesis with the stump is performed through the socket. Good socket stump fit provides near-normal posture and weight-transfer pattern. It also ensures that the walk is painless and low-energy.
- Conditions
- Transtibial Amputee, Loading, Conventional, 3D
- Trial name
- NCT04326712
- Testing
- conventional manufactured socket, 3D manufactured socket
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people
- Sponsor
- Marmara University
Amputees, Exercise Training
Spinal Stabilization Exercises in Individuals With Transtibial Amputatıon
Lower extremity amputation causes rapid changes in musculoskeletal system. With the effect of these changes, the energy requirement for prosthetic ambulance is much higher than normal ambulance.
- Conditions
- Amputees, Exercise Training, Physiotherapy, Energy Metabolism
- Trial name
- NCT04114175
- Testing
- Exercise BE, Exercise BE+SS
- Where
- Turkey (Türkiye)
- Volunteers
- 18 people
- Sponsor
- Baskent University
Amputation, Telerehabilitation
Telerehabilitation in Individuals With Unilateral Transtibial Amputation
It is aimed to investigate the effects of telerehabilitation-based structured exercise on muscle strength, balance, performance, body image, prosthesis adaptation, activity limitation, prosthesis use satisfaction, and quality of…
- Conditions
- Amputation, Telerehabilitation, Exercise, Prosthesis User
- Trial name
- NCT04968691
- Testing
- Telerehabilitation based exercise treatment, Home based exercise treatment
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Mehmet Kurtaran
Trauma, Diabetes
Long Term Clinical Evaluation of SLS Transtibial Sockets
The overall long-term goal of this project is the development of a clinically practical system for rapid prosthetic limb provision that integrates computer-aided design with solid freeform fabrication techniques.
- Trial name
- NCT00167570
- Testing
- Prosthetic socket fabricated using selective laser sintering
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center at San Antonio
Amputation, Fall
Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees
Researchers aim to compare demographic characteristics, prosthesis type, functional capacity, and quality of life between faller and non-faller transtibial amputees.
- Conditions
- Amputation, Fall, Ambulation Difficulty, Quality of Life
- Trial name
- NCT05999539
- Testing
- Transtibial prosthesis
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people
- Sponsor
- Eastern Mediterranean University
Amputee, Prostheses
Evaluation of the Biomechanics of Crowding and the Energetic Cost of Endurance Runners Unilateral Transtibial Amputees.
Transtibial amputation accounts for 3,700 cases per year in France. Athletes can use sport blades made of carbon plate for improved energy restitution.
- Conditions
- Amputee, Prostheses, Healthy Volunteers
- Trial name
- BLADENDURUN (NCT06948695)
- Testing
- Warm-up, Random blade test, Comfort speed test
- Where
- France
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
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, 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
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System.
- Trial name
- TTeOPRA+MB (NCT06391697)
- Testing
- eOPRA Implant System for Transtibial Amputees and Magnetic Bead Tracking System
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Brigham and Women's Hospital