Clinical trials: Amputation of Upper Limb, open to volunteers
Amputation
A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception
The hypothesis of this research protocol is that the investigators will be able to redesign the manner in which upper limb amputations are performed so as to enable volitional control of next generation prosthetic devices and…
- Trial name
- NCT03882073
- Testing
- Modified amputation procedure, Standard amputation procedure
- Where
- 4 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury
Research on Wireless Brain Implant System for General Control of External Devices
The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive…
- Conditions
- Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury, Brainstem Stroke, Amyotrophic Lateral Sclerosis
- Trial name
- RISE (NCT06829212)
- Testing
- WRS
- Where
- China
- Volunteers
- 4 people
- Sponsor
- Shanghai StairMed Technology Co., Ltd.
Amputation, Congenital, Upper Limb; Amelia
CNS Changes Following Upper Limb Loss
The objective of this study is to better understand the structural and functional changes that the central nervous system (CNS) undergoes following congenital upper limb loss.
- Trial name
- NCT06043518
- Testing
- MRI
- Where
- Switzerland
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University of Zurich
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
Amputation
Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.
The study will enroll 20 adults ages 18-75 with a transtibial amputation with mature residual limbs who are ambulatory prosthesis users.
- Trial name
- NCT04839497
- Testing
- Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Major Extremity Trauma Research Consortium
Phantom Limb Pain After Amputation, Lower Limb Amputation Above Knee
Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System
This study tests whether a vibration-based feedback device (Suralis) can reduce phantom limb pain in people with lower-leg amputations over 3 weeks.
- Conditions
- Phantom Limb Pain After Amputation, Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee, Lower Limb Amputation Knee
- Trial name
- NCT07324109
- Testing
- Vibrotactile sensory feedback
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Median
Intrathecal, Dexmedetomidine
Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity
The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.
- Conditions
- Intrathecal, Dexmedetomidine, Fentanyl, Bupivacaine
- Trial name
- NCT07276867
- Testing
- Fentanyl + Dexmedetomidine, Fentanyl
- Where
- Egypt
- Volunteers
- 58 people
- Sponsor
- National Cancer Institute, Egypt
Amputation of Upper Limb
A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients
This non-interventional clinical investigation is initiated for the purpose of long-term Post-Market Clinical Follow-up (PMCF) and the follow-up time of patients is expected to span from 6 months to >20 years in function.
- Trial name
- ReTHro (NCT06753110)
- Testing
- OPRA transhumeral
- Where
- 6 sites in Australia, Austria and 3 more
- Volunteers
- 70 people
- Sponsor
- Integrum
Amputation, Amputation, Traumatic
Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control
The goal of this clinical trial is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control translates to functional performance when tested on individuals aged 18 years…
- Conditions
- Amputation, Amputation, Traumatic, Amputation, Congenital, Prosthesis User
- Trial name
- NCT07011420
- Testing
- Experimental socket with 4 untargeted channels active, Experimental socket with 8 untargeted channels active, Experimental socket with up to 16 untargeted channels active
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Liberating Technologies, Inc.
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 and Implants
Transdermal Compress IDE Study
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
- Trial name
- NCT06134167
- Testing
- Transdermal Compress Device
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Balmoral Medical company
Upper Limb Amputation Above Elbow, Upper Limb Amputation Below Elbow
Long-Term Stability of the Glide Control Strategy
This research is intended to test whether the prescription of the Glide prosthesis control system reduces the burden of use for both patients and their clinical care team as compared to use of Pattern Recognition-based advanced…
- Trial name
- NCT07222085
- Testing
- Glide Control System, Pattern Recognition System
- Where
- 10 sites in United States
- Volunteers
- 12 people
- Sponsor
- Infinite Biomedical Technologies
Transfemoral Amputation
Assessment of Strength, Balance, and Function in Above-Knee Amputees in Relation to Residual Limb Length
The goal of this observational study is to learn how muscle strength, balance, and functional ability are affected in people with above-knee (transfemoral) amputations.
- Trial name
- NCT07032233
- Where
- Turkey (Türkiye)
- Volunteers
- 15 people
- Sponsor
- Ceren Kuzu
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
Amputation, Prosthesis User
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses.
- Conditions
- Amputation, Prosthesis User, Amputation; Traumatic, Leg: Thigh, Between Hip and Knee, Limb; Absence, Congenital, Lower
- Trial name
- NCT06937242
- Testing
- Ottobock C-Leg 4 Microprocessor Knee, Ottobock Kenevo
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Hanger Institute for Clinical Research and Education, LLC
Upper Limb Amputation, Healthy Subjects
Microneurography and Intraneural Microstimulation for Upper Limb Sensory Investigation in Healthy and Amputee Subjects
The goal of this experimental study is to investigate the somatosensory system through intraneural recording and stimulation of the median nerve in healthy volunteers and participants with upper-limb amputation.
- Trial name
- MICROAMP (NCT07691957)
- Testing
- Microneurography, Intraneural Microstimulation
- Where
- Italy
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana
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
Amputation of Upper Limb, Agenesis of Upper Limb
Using Sensorimotor Reorganization Following Upper Limb Amputation to Improve Prosthetic Control
Amputation of an upper limb results in a disruption of the sensorimotor loop and a reorganization of the nervous system, leading to the emergence of a phantom limb and the adaptation of compensatory motor strategies.
- Trial name
- REINVENT (NCT07666204)
- Testing
- Caracterisation, Mapping, Phantom sensations
- Where
- 2 sites in France
- Volunteers
- 50 people
- Sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Amputation, Upper Limb
Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis.
- Trial name
- NCT06539936
- Testing
- Glide, Direct Control
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Infinite Biomedical Technologies
Prosthesis User, Prosthesis
Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
This study is focused on optimizing methods for controlling upper-limb myoelectric prosthetic arms. If you are enrolled in this study you would be expected to visit one of the research sites for approximately 5 in-lab visits…
- Conditions
- Prosthesis User, Prosthesis, Prosthetic, Upper Limb Amputation
- Trial name
- NCT07850544
- Testing
- Condition A: Electrode Configuration, Condition B: Electrode Configuration, Condition C: Electrode Configuration
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Liberating Technologies, Inc.