Clinical trials: Lower Limb Amputation
Lower Extremity Amputation
Weight Loss Intervention for Individuals With Lower Extremity Amputation
The purpose of this study is to pilot test a program to help overweight and obese individuals with a lower extremity amputation (LEA) lose weight and become more physically active.
- Trial name
- MOVE-LEAP (NCT02085785)
- Testing
- Coached group, Self-directed control group, Screened only
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- VA Office of Research and Development
Amputation
Feasibility of Neural Feedback for Lower Limb Amputees
The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees.
- Trial name
- NCT03409133
- Testing
- Stimulating nerve electrodes and intramuscular recording electrodes
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Louis Stokes VA Medical Center
Unilateral Amputation of the Lower Limb
Virtual Reality Applied to the Evaluation and Rehabilitation of Locomotion - Study of Tolerance in the Lower Limb Amputee
The adaptability of the locomotor activity allows to face all the modifications of the immediate environment met in the daily activities.
- Trial name
- REVA (NCT05635799)
- Testing
- Analysis of walking on flat ground, Hospital Anxiety Disorder Questionnaire, Analysis of walking on slopes
- Where
- France
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon
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
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
Fractures, Bone, Stroke
Tele-Rehabilitation Pilot Evaluation Study
A proof of concept randomized controlled trial (RCT) only evaluated the National University of Singapore's (NUS) T-Rehab tele-rehabilitation (TR) system at a home setting where rehabilitation was provided on an individual level.
- Conditions
- Fractures, Bone, Stroke, Lower Limb Joint Replacement (Hip or Knee), Lower Limb Amputation
- Trial name
- NCT03409354
- Testing
- Tele-rehabilitation, Usual care
- Where
- Singapore
- Volunteers
- 14 people
- Sponsor
- National University of Singapore
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
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
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
Diabetic Foot Ulcer
Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy
The goal of this study is to learn if the clinical effects of Negative Pressure Wound Therapy (NPWT) is better, worse or the same as standard wound care for patients with diabetic foot ulcers (DFUs).
- Trial name
- DIANE (NCT06721754)
- Testing
- Negative Pressure Wound Treatment
- Where
- 2 sites in Norway
- Volunteers
- 50 people
- Sponsor
- University Hospital, Akershus
Lower Extremity Amputation
Instrumental Analysis of Walking in People With Osseointegrated Prostheses for Lower Extremity Amputation: Comparative Evaluation With Traditional Socket Prostheses
The currently accepted standard for rehabilitation and mobility following amputation is a socket-mounted prosthesis. Osseointegration is an alternative method that has gradually gained greater acceptance in the last 30 years.
- Trial name
- AStrO-OI (NCT04934839)
- Testing
- Test of standing balance (Equitest System). Test of walking in tied and split conditions on a force-sensorized split-belt treadmill.
- Where
- 2 sites in Italy
- Volunteers
- 8 people
- Sponsor
- Istituto Auxologico Italiano
Lower Extremity Amputation
Adherence and Perspiration While Wearing Lower Limb Prostheses
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses.
- Trial name
- NCT03900845
- Testing
- Dynamic Air Exchange - Rising Edge Design (DAE-RED), Perforated elastomeric liner, As-prescribed prosthesis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
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
Amputation, Diabetes Mellitus
Dysvascular Amputation Self-Management of Health
The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.
- Conditions
- Amputation, Diabetes Mellitus, Peripheral Artery Disease
- Trial name
- DASH (NCT04083456)
- Testing
- Walking Biobehavioral Intervention, Attention Control
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Colorado, Denver
Lower Limb Amputation Below Knee (Injury)
The Effects of Small Variations in Shoe Heel Height on Gait in People With a Transtibial Amputation
Prosthetic alignment is important for walking function and walking comfort in people with a transtibial amputation (TTA). Prosthetic alignment is defined as the position of prosthetic parts relative to the body and to each other.
- Trial name
- NCT04641845
- Testing
- Cork inlay wedge
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Sint Maartenskliniek
Diabetic Foot
Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot
The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot.
- Trial name
- NCT00224796
- Testing
- V.A.C. ® System
- Volunteers
- 146 people
- Sponsor
- KCI USA, Inc
Leg Lower Amputation, Traumatic Amputation
The Injury and Its Consequences in the Sports Lower Limb Amputee
This study was motivated by the lack of data in the literature on the injury of the major lower limb amputee playing sports and its socio-professional impact. It aims to study sports-related injuries in lower limb amputees.
- Trial name
- PREV'AMP SPORT (NCT05059886)
- Testing
- completion of a questionnaire on the practice of sports and possible injuries
- Where
- France
- Volunteers
- 45 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Surgical Wound, Wound Heal
Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations
The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.
- Conditions
- Surgical Wound, Wound Heal, Amputation
- Trial name
- NCT03250442
- Testing
- PrevenaTM Device, Standard Dry Dressing
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Georgetown University
Daibetic Foot
A Comparison of General Versus Peripheral Nerve Block for Lower Extremity Amputation in Diabetic Patients With Bleeding Tendency: a Retrospective Study
Retrospective data collection. The aim of this study is to compare general anesthesia and nerve block anesthesia with respect to the postoperative complications in patients undergoing diabetic leg amputation and having bleeding…
- Trial name
- NCT05012059
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Yonsei University
Amputations, Diabetes
Clinical Trial of Footwear in Patients With Diabetes
A Seattle VA study indicated lower extremity ulcers preceded 84% of diabetic amputations. Nearly half of the events that ban the causal chain leading to ulcers and amputation were initiated by ill-fitting footwear.
- Conditions
- Amputations, Diabetes, Lower Extremity Ulcers
- Trial name
- NCT00032864
- Sponsor
- US Department of Veterans Affairs