Clinical trials: Amputee
Transtibial Amputation
Metabolic Cost Savings for Transtibial Amputees Wearing the Controlled Energy Storage and Return (CESR) Foot
To determine if below-knee amputees will walk with better efficiency wearing a CESR foot which stores energy at heel strike and releases energy releases energy during push-off.
- Trial name
- NCT00494143
- Testing
- CESR Prosthetic Foot, typical prosthetic foot, standardized prosthetic foot
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Post-Amputation Pain, Phantom Limb Pain
Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System.
- Conditions
- Post-Amputation Pain, Phantom Limb Pain, Residual Limb Pain
- Trial name
- NCT01996254
- Testing
- SPRINT Peripheral Nerve Stimulation (PNS) System
- Where
- 10 sites in United States
- Volunteers
- 28 people
- Sponsor
- SPR Therapeutics, Inc.
Stroke, Peripheral Neuropathy
Arm Motor Control on Bi and Uni ADLs
This study is being performed to assess how certain chronic disabilities - stroke, upper extremity (UE) amputation, spinal cord injuries (SCI), cerebral palsy (CP) - differ from healthy subjects in their ability to perform ADLs.
- Conditions
- Stroke, Peripheral Neuropathy, Spinal Cord Injuries, Cerebral Palsy
- Trial name
- BiAs (NCT02778529)
- Testing
- Bilateral assessment robots (BiAS)
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Amputation; Traumatic, Hand
To Assess the Utility of the Point Partial in a Clinical Take-home Study of Partial Hand Amputees
This study will allow us to assess whether the Point Partial confers functional and psychological benefit to persons with partial finger amputations in an unconstrained environment.
- Trial name
- NCT05012683
- Testing
- Point Partial
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Point Designs
Amputation
EmPOWERing Active Seniors With Energy
A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.
- Trial name
- EASE (NCT02958553)
- Testing
- emPOWER Ankle, Subject's own passive prosthesis
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Transtibial Amputation
Evaluation of a Modified Running-specific Prosthetic Foot
The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF)…
- Trial name
- NCT02440711
- Testing
- Energy storing foot (ESF), Modified running specific foot (mRSF)
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Washington
Traumatic Amputation of Lower Extremity
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at the same speeds as non-amputees and this discrepancy is more apparent at faster walking speeds.
- Trial name
- NCT00869947
- Testing
- Powered ankle-foot prosthesis, No device
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Prosthesis User, Amputation
An Investigation of Functional Improvements in the RHEO KNEE Compared to Hydraulic Microprocessor Controlled Knees (MPKs)
The aim of this study was to evaluate the mobility, perceived safety and functioning of unilateral transfemoral (TF) amputees using the Rheo Knee XC compared to their existing prosthetic knee (RHEO KNEE II, III or Genium, X2 or…
- Trial name
- NCT04023578
- Testing
- RHEO KNEE XC
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Össur Iceland ehf
Transfemoral Amputation, Unilateral Traumatic Amputation of Leg at or Above Knee
Functional Outcomes in Dysvascular Transfemoral Amputees
In older adults, poor circulation in the lower extremities leads to serious health complications including limb loss. In addition, individuals with dysvascular disease also suffer from other co-morbidities like diabetes, coronary…
- Trial name
- CLEG (NCT01537211)
- Testing
- C leg compared to subject's mechanical leg (Otto Bock)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Shirley Ryan AbilityLab
Amputation
Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
Many service members suffering major limb amputation(s) during active duty seek to return to active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular…
- Trial name
- NCT01404559
- Testing
- Ossur Variflex prosthetic foot, Ossur Ceterus prosthetic foot, Endolite Elite Blade prosthetic foot
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Amputation, Amputation; Traumatic, Hand
Dexterous Partial Hand Prosthesis Outcomes
Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp.
- Conditions
- Amputation, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper, Prosthesis User
- Trial name
- NCT05038566
- Testing
- Pointdexter
- Where
- 2 sites in United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Phantom Limb
Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain
The goal of this study is to test whether a combination of cognitive-behavior therapy and mirror training reduces phantom limb pain for veterans with amputations.
- Trial name
- NCT00731614
- Testing
- Cognitive Behavioral Therapy and Mirror Retraining, Supportive therapy, Mirror retraining
- Where
- 3 sites in United States
- Volunteers
- 59 people
- Sponsor
- VA Office of Research and Development
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
Prosthesis User
Efficacy of a Vented Liner and Socket System for Individuals With Trans-femoral Amputation
The objective of the investigation is to measure the humidity within a transfemoral amputee's prosthesis during physical activity in a pre-heated room, using both the vented AeroFit system and a non-vented comparator.
- Trial name
- NCT05279885
- Testing
- Vented suspension system, Non-vented suspension system
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Jóna Valgerður Kristjánsdóttir
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
Transtibial Amputation
Effects of Shrinker Use on Healing and Volume
We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers.
- Trial name
- NCT00693628
- Testing
- compression shrinker
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Oklahoma
Phantom Limb Pain
Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.
- Trial name
- NCT02627495
- Testing
- transcranial Direct Current Stimulation (tDCS): (Soterix ©)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Spaulding Rehabilitation Hospital
Amputation; Traumatic, Hand
Validation of Point Partial User Needs With Partial Finger Amputees
The objective of the device feasibility study will be to validate the user needs of the Point Partial system. This study will be a single group intervention model where one group of 5 partial finger amputees will be asked to…
- Trial name
- NCT05012657
- Testing
- Point Partial
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Point Designs
Spinal Cord Injuries, Amputees
Understanding Quality and Equity in Wheelchairs for Veterans
The Department of Veterans Affairs (VA) provides wheelchairs to about 42,000 Veterans with SCI and more than 40,000 Veterans with amputated limbs (AL).
- Trial name
- NCT01236170
- Where
- 5 sites in United States
- Volunteers
- 497 people
- Sponsor
- VA Office of Research and Development
Amputation, Limb Loss
Self-management to Improve Function Following Amputation
Lower extremity amputations are a significant cause of morbidity, mortality, loss of function and reduced quality of life. Self-management (defined as the process by which an individual adopts an active role in managing the…
- Trial name
- VETPALS (NCT02163811)
- Testing
- VETPALS, Individual Education Support Program
- Where
- 5 sites in United States
- Volunteers
- 182 people
- Sponsor
- VA Office of Research and Development