Clinical trials: Transfemoral Amputation
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 Limb Amputation Above Knee (Injury)
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on…
- Trial name
- NCT02765035
- Testing
- C-Leg 4, C-Leg 3
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 18 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Peripheral Arterial Disease, Peripheral Vascular Disease
The Effect of Ischemic Conditioning on Strength and Ambulation in Subjects with PAD
Lower limb amputation is common in the United States, with approximately 150,000 amputations annually. Most individuals walking with a prosthesis demonstrate asymmetrical loading-i.e., they favor the amputated side by placing…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Amputation, Lower Limb Amputation Knee
- Trial name
- NCT04937179
- Testing
- Ischemic Conditioning High - Active Comparator
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Illinois at Chicago
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
The aim of the study is to evaluate the changes induced by a course of Transcutaneous Electrical Nerve Stimulation (TENS) treatment on the perception of phantom limb pain.
- Trial name
- SENSE-P (NCT07448350)
- Testing
- Transcutaneal Electrical Nerve Stimulation
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- Campus Bio-Medico University
People With Trans-femoral Amputation
Effects of Microprocessor-controlled Knee Joints on Community Outcomes
About 21% to 35% of people with limb loss are those who lost their limb at trans-femoral level (i.e. above the knee). The increasing number of diabetes-related limb loss (amputation) and the rising proportion of older adult…
- Trial name
- NCT04112901
- Testing
- Microprocessor-controlled knee joints, Non-microprocessor-controlled knee joints
- Volunteers
- 330 people
- Sponsor
- University of Derby
Transfemoral Amputation
An Osseointegrated Transfemoral Prosthesis Offering Long-Term Bi-Directional Efferent-Afferent Neural Transmission
The purpose of the study is to investigate the clinical and functional outcomes of a transfemoral amputation with osseointegrated titanium implant, AMI muscle constructs, and implanted electrodes in the domain of gait, free space…
- Trial name
- NCT07615465
- Testing
- MIT Powered Knee Prosthesis
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Massachusetts Institute of Technology
Amputation
Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis
People with lower extremity amputation (LEA) have persistent problems with balance, falls, residual limb pain, functional mobility, cognitive attention during gait, and satisfaction with participation in daily activities, despite…
- Trial name
- NCT06214026
- Testing
- META-Arc foot locked, META-Arc foot unlocked
- Where
- 3 sites in United States
- Volunteers
- 96 people
- Sponsor
- University of Washington
Amputation, Prosthesis User
Effectiveness and Cost-effectiveness of Lower Limb Prostheses
The goal of this observational study is to investigate the effectiveness of NMPKs versus MPKs in persons with an LLA in the standard healthcare system in the Netherlands taking all levels of the ICF model into account.
- Conditions
- Amputation, Prosthesis User, Prosthesis
- Trial name
- NCT06031922
- Testing
- Microprocessor controlled knee
- Where
- 9 sites in Netherlands
- Volunteers
- 28 people
- Sponsor
- University Medical Center Groningen
Lower Limb Amputation Above Knee, Below Knee Amputation
Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation
The goal of this clinical trial is to learn if ischemic conditioning and neuromuscular electrical stimulation improves muscle strength and walking behavior in those with limb loss.
- Trial name
- NCT07664995
- Testing
- Blood pressure cuff, Neuromuscular Electrical Stimulation
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Illinois at Chicago
Transfemoral Amputation, Transtibial Amputation
Mobile Device Outcomes-based Rehabilitation Program
This joint research project between the Department of Veterans Affairs (VA) and Department of Defense (DoD) will demonstrate that the implementation of the Mobile Device Outcomes-based Rehabilitation Program (MDORP) will improve…
- Trial name
- MDORP (NCT02891707)
- Testing
- Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
Lower Limb Amputation, Older Adults
Study of WiiFit to Enhance Walking in Older Adult Amputees
WiiNWALK is a 4 week physical activity, with the intervention of a WiiFit, targeted to improve walking capacity in individuals with either a unilateral below-knee or above-knee amputation.
- Trial name
- WiiNWalk (NCT01942798)
- Testing
- Nintendo Wii, Wii Big Brain Academy Degree program
- Where
- 5 sites in Canada
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Amputation, Prosthesis User
Economic Evaluation of Lower Limb Prostheses for Persons With a Knee-disarticulation or Transfemoral Amputation
The goal of this retrospective questionnaire study is to evaluate the cost-effectiveness of non-microprocessor controlled prosthetic knees (NMPK) versus microprocessor controlled prosthetic knees (MPK) in persons with a…
- Conditions
- Amputation, Prosthesis User, Prosthesis
- Trial name
- NCT06105944
- Where
- 2 sites in Netherlands
- Volunteers
- 117 people
- Sponsor
- University Medical Center Groningen
Transfemoral Amputation, Limb Loss
A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation
Microprocessor-controlled knees (MPKs) do not typically utilize motors to power joint rotation, but they automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the…
- Conditions
- Transfemoral Amputation, Limb Loss, Limb Absence
- Trial name
- OPKTFA (NCT06218238)
- Testing
- Powered prosthetic knee joint, Conventional microprocessor-controlled prosthetic knee joint
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- VA Office of Research and Development
Unilateral Transfemoral Amputation, Unilateral Knee Disarticulation
Real-time Motion Capture and Visual Feedback for Amputation Gait Training
People with transfemoral amputation face challenges such as gait asymmetry, instability, and increased energy consumption due to loss of the knee joint.
- Trial name
- NCT07049198
- Testing
- Real-time 2D motion capture and visual feedback system gait training, Conventional physical therapy group
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- National Yang Ming Chiao Tung University
Amputation
Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee
The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard…
- Trial name
- NCT02773056
- Testing
- Ischial Ramus Containment (IRC), Dynamic Socket Ischial Ramus Containment (IRC), Sub-Ischial Interface (Sub-I)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of South Florida
Amputation, Prostheses and Implants
Regenerative Peripheral Nerve Interface for Control of Lower Limb Prostheses
Individuals with an above-knee lower limb amputation are known to walk more slowly, expend more energy, have a greater risk of falling, and have reduced quality of life compared to individuals without amputation and those with…
- Trial name
- NCT06275282
- Testing
- Intramuscular electrodes
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Michigan
Amputation, Transfemoral Amputation
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
This randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy…
- Conditions
- Amputation, Transfemoral Amputation, Osseointegration
- Trial name
- TOPLOAD (NCT05695911)
- Testing
- Limb Load Biofeedback Training Intervention, Attention Control
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Colorado, Denver
Amputation, Traumatic Amputation
Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level
The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees. The main question it aims to answer are: Is to verify the technical functionality, safety and…
- Conditions
- Amputation, Traumatic Amputation, Leg Injury, Lower Limb Injury
- Trial name
- MOTU-ATP (NCT06284005)
- Testing
- WRL ATP
- Where
- Italy
- Volunteers
- 4 people
- Sponsor
- Fondazione Don Carlo Gnocchi ETS
Mastectomy, Upper Limb Amputation Below Elbow
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this…
- Conditions
- Mastectomy, Upper Limb Amputation Below Elbow, Upper Limb Amputation Above Elbow, Lower Limb Amputation Below Knee
- Trial name
- NCT03578237
- Testing
- Cryoneurolysis (active)
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- University of California, San Diego
Transfemoral Amputation
The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study
The global goal of the CYBERnetic LowEr-limb coGnitive ortho-prosthesis Plus Plus (CLs++) project is to validate the technical and economic viability of the powered robotic ortho-prosthesis developed within the 7th Framework…
- Trial name
- CLs++1stCS (NCT03296904)
- Testing
- CLs++
- Where
- Italy
- Volunteers
- 8 people
- Sponsor
- Fondazione Don Carlo Gnocchi ETS