Clinical trials: Transtibial Amputee
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
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
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
Unilateral Trans-tibial Amputees
Hull Early Walking Aids for Transtibial Amputees - Randomised Control Trial (HEART)
Early walking aids are routinely used in UK for rehabilitation of patients with below knee amputations. The two main walking aids used commonly in practice include the non-articulated Pneumatic Post Amputation Mobility Aid…
- Trial name
- HEART (NCT01024023)
- Testing
- EWA
- Where
- 3 sites in United Kingdom
- Volunteers
- 26 people
- Sponsor
- University of Hull
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
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
Amputees / Rehabilitation, Virtual Reality
Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
Amputation causes somatic and psychological damage. Prognostic factors for postoperative gait recovery include the need for proprioceptive re-education for dynamic balance.
- Conditions
- Amputees / Rehabilitation, Virtual Reality, Postural Balance
- Trial name
- EQUIL-ARC (NCT06424249)
- Testing
- Virtual Reality, Standard rehabilitation
- Where
- 2 sites in France
- Volunteers
- 20 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
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
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
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
Amputation of Lower Limb Below Knee, Amputation, Traumatic
REsistance and LOADing Exercise for Bone Health
Lower limb amputation, often resulting from military conflict and road traffic accidents, is associated with reduced hip bone mineral density (BMD) and increased risk of hip fractures.
- Conditions
- Amputation of Lower Limb Below Knee, Amputation, Traumatic, Amputation, Limb Loss
- Trial name
- RELOAD (NCT07817381)
- Testing
- Resistance and high-impact exercise training
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Defence Medical Rehabilitation Centre, UK
Amputee
Try Walking a Mile in These Shoes: Activity Level of Lower Extremity Amputees
The purpose of this study is to compare the accuracies of the Patient Activity Monitor to that of a standard pedometer during a walking task and some day-to-day activities in a simulated apartment setting.
- Trial name
- PamPed (NCT00439088)
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Ottawa
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
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
Amputation
Prosthetic Limbs After Leg Amputation: Alternative Method of Socket Design
People who have had a leg amputated often choose to use a prosthetic (artificial) leg. This study will evaluate a new method of making prosthetic legs for people who have had an amputation below the knee.
- Trial name
- NCT00061217
- Testing
- Unrectified prosthetic socket, Rectified prosthetic socket
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Vascular Diseases
Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees
The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation.
- Trial name
- NCT00616668
- Testing
- Air- Limb
- Volunteers
- 20 people
- Sponsor
- Sheba Medical Center
Amputation
COMPARISON OF THE EFFECTS OF TELEREHABILITATION AND FACE-TO-FACE SPINAL STABILIZATION TRAININGS ON GAIT BIOMECHANICS, BALANCE AND JOINT POSITION SENSE IN TRANSTIBIAL AMPUTEES: A RANDOMIZED CONTROLLED, SINGLE BLIND STUDY
After transtibial amputations, biomechanical changes in the trunk, pelvis, and lumbar region cause asymmetrical strength and core muscle activation on the amputated side, which negatively affects the gait biomechanics of…
- Trial name
- NCT05569967
- Testing
- Spinal stabilization training through telerehabilitation, Spinal stabilization training face-to-face
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people
- Sponsor
- Ankara Yildirim Beyazıt University