Clinical trials: Lower Limb Amputees
Amputation
Comparative Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot.
The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars: 1. The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a…
- Trial name
- DEFI (NCT06627361)
- Testing
- PRO-FLEX PIVOT Foot evaluation, Class III ESAR Foot evaluation
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Össur Iceland ehf
Traumatic Lower Limb Amputation, Fatigue
Effect of Adding Progressive Muscle Relaxation to Physical Therapy Program on Fatigue, Mobility and Stress Among Individuals With Traumatic Lower Limb Amputation in the Gaza Strip
Lower limb amputation is a life-altering condition with profound physical and psychological consequences, including fatigue, impaired mobility, stress, and asymmetrical weight-bearing.
- Conditions
- Traumatic Lower Limb Amputation, Fatigue, Mobility Impairment, Psychological Stress
- Trial name
- PMR-AMP (NCT07139145)
- Testing
- Progressive Muscle Relaxation + Standard Physiotherapy, Standard Physiotherapy
- Where
- Palestinian Territories
- Volunteers
- 60 people
- Sponsor
- Marah Radi
Lower Extremity Amputee, Diabetic Peripheral Neuropathy
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with above and below the knee limb loss.
- Trial name
- NCT04658693
- Testing
- Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- VA Office of Research and Development
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Pain in Trans Femoral and Trans Tibial Amputees
Phantom limb is difficult to manage and has a significant impact on the patient's quality of life. At present, the scientific evidence shows that the infusion of local anesthetics with epidural and perineural catheters in the…
- Trial name
- AMPUPHANTOM (NCT03789435)
- Testing
- Questionnaire
- Where
- Italy
- Volunteers
- 73 people
- Sponsor
- Istituto Ortopedico Rizzoli
Lower Limb Amputation Above Knee (Injury)
The CYBERnetic Lower Limb Cocognitive Ortho-prosthesis Plus Plus, 1st Clinical Study (CLs++)
The aim of the study is to assess the efficacy and the usability of the cyberlegs ++ ortho prosthesis to improve the mobility and the quality of life in transfemoral amputees .
- Trial name
- NCT03376919
- Testing
- CLs++ gait training
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vrije Universiteit Brussel
Amputation, Traumatic
Relationship Between Gait Variability and Sensation
Twenty individuals who were referred to receive physiotherapy will be participants of the study. Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body…
- Trial name
- NCT02934074
- Testing
- No intervention
- Volunteers
- 20 people
- Sponsor
- Hacettepe University
Amputation of Lower Limb Above Knee, Amputee
Bio Leg: Advancing Mobility (BAM)
Following transfemoral amputation, regaining functional mobility, particularly the ability to navigate curbs, ramps, long distances, and the ability to stand is challenging and often unattainable.
- Conditions
- Amputation of Lower Limb Above Knee, Amputee, Amputation
- Trial name
- BAM (NCT07613502)
- Testing
- Bio Leg
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Florida
Lower Limb Amputation
Muscle Strength Training in Lower Limb Amputee Patients
This study is a clinical trial that evaluates the best treatment option using a strength training protocol and an endurance training protocol in patients with lower limb amputations who use prostheses.
- Trial name
- NCT07261852
- Testing
- Muscle strengh training, Resistence training
- Volunteers
- 18 people
- Sponsor
- University of Gran Rosario
Prosthesis User, Amputation
Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees
To assess the functional characteristics and utility of upper and lower limb prosthetic devices (advanced bionic and current clinical standard-of-care) that incorporate physiologically relevant touch and/or movement feedback.
- Trial name
- NCT03135847
- Testing
- Tactor
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
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
Amputation
Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees
Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb.
- Trial name
- NCT01559909
- Testing
- Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Stony Brook University
Lower Limb Amputation Knee, Lower Limb Amputation Below Knee (Injury)
Validity and Reliability of The 3-Meter Backward Walk Test in Individuals With Lower Limb Amputation
Clinicians are routinely required to make decisions about fall risk among lower limb prosthesis users. For these decisions, clinicians should use valid, reliable, quantitative, and multidimensional measures of balance test for…
- Trial name
- NCT05095584
- Testing
- 3 meter backward walk test
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tezel Yıldırım Şahan
Lower Limb Amputation at Ankle (Injury)
Comparing New Prothesis PROPRIO-FOOT® Versus Usual Prothesis Tasks Tibial Amputees
Evaluate a new porosthetic device in lower limb amputees.
- Trial name
- PROPRIO-FOOT (NCT02501408)
- Testing
- propriofoot prosthesis
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Angers
Traumatic Amputation of Lower Extremity, Phantom Limb Pain
Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day
The goals of this study are to provide sensory information to amputees and reduce phantom limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves.
- Trial name
- SCS-90 (NCT04547582)
- Testing
- Spinal cord stimulator
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Lee Fisher, PhD
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
Amputee, Plantar Pressure Distrubution
Comparison of Different Amputation Levels
Lower limb amputation is a factor that changes the individual's weight transfer, gait pattern, and trunk balance. This change plantar pressure distribution of both side and cause a series of problems to be exposed over time…
- Conditions
- Amputee, Plantar Pressure Distrubution, Balance
- Trial name
- NCT04330274
- Testing
- Bipedal with open eyes, Bipedal with closed eyes, Bipedal with open eyes and with platform
- Where
- Turkey (Türkiye)
- Volunteers
- 85 people
- Sponsor
- Marmara University
Lower Limb Amputation
Walking Strategies in Usual Locomotion of Lower Limb Amputees
Amputation is a life-altering event with an immediate and obvious effect on daily life activities and quality of life. Asymmetrical movements of the lower limbs and compensatory strategies during walking are associated with an…
- Trial name
- STRAAL (NCT05420623)
- Where
- France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- FondationbHopale
Amputation, Diabetes Complications
Study to Determine if Different Prosthetic Sockets Effect How Much Oxygen is in the Tissue of Lower Limb Amputees While They Are Walking
Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow.
- Conditions
- Amputation, Diabetes Complications, Leg Injuries, Traumatic Amputation
- Trial name
- NCT00985842
- Testing
- Pe-Lite and sleeve suspension socket, Total Surface bearing a socket with a sleeve suspension but without suction, Total surface bearing suction socket with a pin lock suspension
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- VA Office of Research and Development
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, Lower Limb Amputation
Effect of PNF-Based Upper Extremity Strengthening With Core Stabilization on Fitness in Amputee Football Players
Amputee football (AF) is a disability-specific football in which amputees can participate. This study aims to determine the effect of PNF-based upper extremity strengthening exercises combined with core stabilization exercises on…
- Trial name
- NCT06556082
- Testing
- Training, Control Group
- Where
- Turkey (Türkiye)
- Volunteers
- 14 people
- Sponsor
- Uskudar University