Clinical trials: Lower Extremity Amputation
Trans-tibial Limb Loss
Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces During Walking
In human gait there is a certain amount of variation between steps; some considered physiological and owed to variations in environment or posture, and some severe enough to be indicative of gait instabilities that may lead to…
- Trial name
- NCT02234505
- Testing
- Prosthetic alignment perturbation
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Amputation, Wound; Foot
Comparing Wound Complication Following TMA With Aid of Electrospun Fiber Matrix
Transmetatarsal amputation (TMA) patient populations commonly have poor healing outcomes and a large number of complications. There has been little study on the benefits of augmenting a TMA with a synthetic graft substitute.
- Conditions
- Amputation, Wound; Foot, Wound Complication
- Trial name
- NCT06063694
- Testing
- Synthetic electrospun fiber matrix
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Scripps Health
Fall Prevention, Balance, Falls
Evaluating Methods to Replicate Stumbles and Slips During Walking
This protocol outlines a study designed to investigate three different methodologies for inducing gait perturbations. Subjects will be divided into two groups: prosthetic users and able-bodied individuals.
- Conditions
- Fall Prevention, Balance, Falls, Amputation of Lower Limb
- Trial name
- NCT07175714
- Testing
- Methodologies to induce gait perturbations
- Where
- 2 sites in Iceland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Össur Iceland ehf
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
Gait, Balance
Gait Stability of People With Lower-limb Amputations
The purpose of this study is to evaluate whether there are quantifiable differences in walking stability, as measured by the acceleration of the trunk or the variation in step length, between people with unilateral below-knee…
- Trial name
- NCT00915109
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Kim Parker
Lower Limb Amputation Above Knee (Injury)
Decoding Motion Planning Using Cortical Potentials
The team will investigate the user's intention to move by using cortical activity during a sit to stand movement performance in people with a transfemoral amputation and able-bodied individuals.
- Trial name
- NCT04325516
- Testing
- Daily activities
- Where
- Belgium
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Vrije Universiteit Brussel
Amputation
Targeted Muscle Reinnervation Study (TMR)
The purpose of this study is to examine the effect of targeted muscle reinnervation on the outcomes of amputees at a level 1 trauma center.
- Trial name
- TMR (NCT05408520)
- Testing
- Targeted Muscle Reinnervation
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Arizona
Amputation, Dysmelia
Physical Activity and Sports for People With Special Needs
Purpose of this study was to assess the balance level of highly qualified amputee football players in relation to their sports level, training experience, position on the pitch, as well as the type of amputation/dysfunction and…
- Conditions
- Amputation, Dysmelia, Leg; Deformity, Congenital
- Trial name
- NCT05778799
- Testing
- Balance test
- Where
- Poland
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Józef Piłsudski University of Physical Education
Lower Limb Amputation Below Knee (Injury)
Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss
This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.
- Trial name
- HumanIT (NCT05818410)
- Testing
- Prosthetic device (Lunaris), No prosthetic device, Prosthetic device (Sach foot)
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Vrije Universiteit Brussel
Lower Limb Amputation Above Knee (Injury)
The CYBERnetic LowEr Imb coGnitive Ortho-prostheis Plus Plus, 2nd Clinical Study (CLs++)
The aim of the project is to evaluate the efficacy of the Cyberlegs X-leg in people with a unilateral transfemoral (above the knee joint) and transtibial (under the knee joint) amputation.
- Trial name
- NCT04129853
- Testing
- Cyberlegs Xleg
- Where
- Belgium
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Vrije Universiteit Brussel
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness Study
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Elevated Metabolic Cost
The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation
To assess the carryover effect of an innovative new gait training program on physiological and functional gait performance in persons with a traumatic lower extremity amputation.
- Trial name
- VRVO2 (NCT01225432)
- Testing
- Gait Training
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Brooke Army Medical Center
Lower Limb Amputation Below Knee, Diabetes (DM)
Skin Temperature Perception and Prosthetic Thermoregulation
To protect against excessive body temperatures, local thermoregulatory mechanisms include temperature sensory nerves (responsive to warm or cool stimuli) and vasomotors (muscles that constrict or dilate blood vessels).
- Conditions
- Lower Limb Amputation Below Knee, Diabetes (DM), Skin Temperature Change, Vascular Reactivity
- Trial name
- NCT07215442
- Testing
- Warming stimulus starting at 30 C initial temperature, Warming stimulus starting at 32 C initial temperature, Warming stimulus starting at 34 C initial temperature
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- VA Puget Sound Health Care System
Trauma
Investigating Outcomes of Lower Limb Trauma
This is an observational study, which aims to firstly develop a sensor-based objective mobility assessment. This will then be used to profile and compare the outcomes of patients who undergo amputation with those who have limb…
- Trial name
- NCT01691950
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Amputation, Traumatic Amputation of Lower Extremity
Sitting Balance in Lower Limb Amputees
The aim of this study is to compare the sitting and standing postural stability of transfemoral individuals with healthy individuals with similar demographic characteristics.
- Trial name
- NCT05597696
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Amputation Wound, Traumatic Amputation of Toe
Longitudinal Study of Weight Change Following Lower Limb Amputation
The purpose of this study is to assess weight change in a population of Veterans with amputations. Little is known about the how weight changes following an amputation.
- Conditions
- Amputation Wound, Traumatic Amputation of Toe, Dysvascular Amputation of Lower Limb
- Trial name
- NCT00932399
- Where
- United States
- Volunteers
- 4,549 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Amputation; Traumatic, Leg, Lower
Design, Prototyping, and Testing of a Robotic Prosthetic Leg
The purpose of this graduate student research study is to test that a specifically designed and novel robotic prosthetic leg (RPL) is feasible, safe and improves symmetry, efficiency, and metabolic function during sit-to-stand…
- Trial name
- NCT04616378
- Testing
- Phase 2 Prescribed Prosthesis, Phase 2 Robotic Prosthetic Leg, Phase 3 No Prosthesis
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Loma Linda University
Amputation, Diabetes
Thermoregulation in Individuals With a Leg Amputation
The goal of this project is to understand the factors that affect skin temperature (e.g., tissue above amputation site, and opposite foot) in people with amputation and diabetes.
- Trial name
- NCT06458426
- Testing
- shock-absorbing prosthesis
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Utah
Perineural, Methylene Blue
Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery
This prospective randomized controlled study will be conducted to evaluate the analgesic effect of continuous perineural infusion of methylene blue with bupivacaine on acute postoperative pain and to evaluate its preventive role…
- Conditions
- Perineural, Methylene Blue, Lower Limb Amputation
- Trial name
- NCT05830630
- Testing
- Bupivacaine methylene blue, bupivacaine saline
- Where
- Egypt
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Tanta University
Amputation, Traumatic
Sonographic Evaluation Of Nerve Thickness In Traumatic Lower-Limb Amputees
Lower limb amputation (LLA) commonly affects young and active people who have long life expectancy. It is a major surgery causing many functional deficiencies which can reduce overall health quality and physical condition of the…
- Trial name
- NCT04602793
- Testing
- ultrasonography
- Where
- Turkey (Türkiye)
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital