Clinical trials: Lower Limb Amputation Knee
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
Asymmetry of the Center of Pressure During Gait After Amputation of Lower Limbs
Retrospective, non-randomized, observational, single-center longitudinal study at the University Rehabilitation Hospital of Grau du Roi CHU of Nîmes, France.
- Trial name
- ASCOPALL (NCT05803317)
- Testing
- usual care : Evaluation of walking on a baropodometric platform
- Where
- France
- Volunteers
- 130 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Study on a Prosthetic Foot With Adjustable Heel Height
Most prosthetic feet have a fixed heel height, which requires users to always wear shoes with the same heel height. A fixed heel height is a significant constraint, whereas the ability to choose one's clothing freely is an…
- Trial name
- ADJUST (NCT07214493)
- Testing
- Taleo Adjust, The usual participant's foot
- Where
- 5 sites in France
- Volunteers
- 30 people
- Sponsor
- Otto Bock France SNC
Prosthesis User, Lower Limb Amputation Below Knee (Injury)
Caesar Foot Take-Home Validation Testing
The rationale for this study is to conduct a take-home clinical trial to evaluate the impact of the bimodal Caesar foot in a real-world environment.
- Trial name
- NCT07075198
- Testing
- Caesar Foot
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Liberating Technologies, Inc.
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
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User
- Trial name
- NCT06194838
- Testing
- Ossur Power Knee, Reboocon Intuy Knee
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Liberating Technologies, Inc.
Lower Limb Amputation Above Knee (Injury)
Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life.
- Trial name
- INCREMENT (NCT06635655)
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Proteor Group
Lower Limb Amputation Below Knee (Injury)
R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
Lower limb amputees (LLA) rely on their prosthetic legs to remain active and lead an independent life. For most LLAs, a well-fitted prosthetic socket is the only option to interface with their prosthetic leg, however, it is a…
- Trial name
- ENABLE (NCT05425810)
- Testing
- Apply ENABLE sensing pad, Insert small pads at pressure tolerant locations
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- North Carolina State University
Lower Limb Amputation Below Knee (Injury)
Effects of Prosthesis Training on Pain, Prosthesis Satisfaction and Ambulatory Status of Lower Limb Amputees
The objective of the study is to assess the effects of prosthesis training with and without phantom exercises on pain, prosthesis satisfaction and ambulatory status of lower limb amputees treated with prosthesis training, phantom…
- Trial name
- NCT06013631
- Testing
- Prosthesis Training, Phantom Exercises
- Where
- Pakistan
- Volunteers
- 50 people
- Sponsor
- University of Lahore
Phantom Limb Pain, Phantom Pain
VR to Evaluate Phantom Limb Pain
The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity…
- Conditions
- Phantom Limb Pain, Phantom Pain, Phantom Sensation, Phantom Limb Syndrome With Pain
- Trial name
- NCT05915065
- Testing
- Coapt Phantom Limb Pain Management System
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Shirley Ryan AbilityLab
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 (Injury)
Evaluation of a Motorised Prosthetic Knee
The study will investigate the effect over time of the Power Knee (Össur) on performance during daily activities in people with a unilateral transfemoral amputation, will determine subjective feelings and gait kinematics over…
- Trial name
- MOKI-B (NCT05407545)
- Testing
- Current prosthesis, Active Prosthesis (PowerKnee)
- Where
- Belgium
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Vrije Universiteit Brussel
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
Amputation, Lower Limb Amputation Knee
Promoting Physical Activity Following Dysvascular Amputation
Loss of a lower limb due to diabetes can have a devastating impact on physical and mental health and quality of life. Individuals are at risk of other diseases such as cardiovascular disease, loss of the other limb and death.
- Trial name
- NCT06667739
- Testing
- IMPACT-L3
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- West Park Healthcare Centre
Lower Limb Amputation Above Knee (Injury)
New Microprocessor-Controlled Prosthetic Knee Evaluation
The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK.
- Trial name
- NCT06017024
- Testing
- microprocessor-controlled knee (MPK) assessment
- Where
- 5 sites in France
- Volunteers
- 18 people
- Sponsor
- Proteor Group
Amputation, Amputation; Traumatic, Leg, Lower
Socket Cooling Effectiveness Take Home 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, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower
- Trial name
- NCT04484805
- Testing
- ICE Condition
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
- Conditions
- Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
- Trial name
- NCT04239222
- Testing
- Revo-M, Taleo, Proflex XC
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Diabetes Mellitus, Critical Limb Ischemia
N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
In this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial for 30 days for participants with critical limb ischemia (CLI) who undergo a major…
- Conditions
- Diabetes Mellitus, Critical Limb Ischemia, Lower Limb Amputation Knee, Peripheral Arterial Disease
- Trial name
- NCT03253328
- Testing
- Active Arm N-acetyl cysteine (NAC)
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Washington University School of Medicine
Amputation, Lower Limb Amputation Above Knee (Injury)
Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)
The main aim of this study is to compare the adaptation capabilities of the microprocessor-controlled knee-ankle prosthesis system with the comparator covered by the French LPPR, known as the "usual prosthesis".
- Trial name
- SPCM (NCT06522646)
- Testing
- SPCM, Usual Prothesis
- Where
- 4 sites in France
- Volunteers
- 12 people
- Sponsor
- Institution Nationale des Invalides
Behavior, Amputation
Self-Management for Amputee Rehabilitation Using Technology.
Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011.
- Conditions
- Behavior, Amputation, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury)
- Trial name
- SMART (NCT04953364)
- Testing
- SMART, Control
- Where
- Canada
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Lower Limb Amputation Below Knee (Injury)
NIH Release/Relock Socket
The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation.
- Trial name
- NCT04305782
- Testing
- Release/Relock Socket - In Lab, Release/Relock Socket - Out of Lab, Release/Relock Socket & Control
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Washington