Clinical trials: Amputation
Pressure Ulcer, Ankle, Prosthesis User
Limb Health and Socket Pressure in Response to Powered Ankle Protheses
this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.
- Conditions
- Pressure Ulcer, Ankle, Prosthesis User, Prosthesis Durability, Mobility Limitation
- Trial name
- OPORP (NCT05112679)
- Testing
- PROPRIO FOOT® by Ossur & Empower ankle by Ottobock
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Indiana University
Lower Extremity Amputation
Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation
When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available.
- Trial name
- NCT03532100
- Testing
- Torsionally adaptive prosthesis with 0:1 coupling ratio, Torsionally adaptive prosthesis with 1:6 coupling ratio, Torsionally adaptive prosthesis with 1:4 coupling ratio
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- VA Office of Research and Development
Prostheses, Upper Limb Amputation Below Elbow
Wireless Prosthetic Control Effectiveness Study
The goal of this proposed project is to evaluate the effectiveness of our novel wireless electrode system, which the investigators refer to as the Asterisk system, on transradial prosthesis users.
- Trial name
- NCT06821412
- Testing
- ASTERISK System, Wired Configuration
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Liberating Technologies, Inc.
Amputation, Prosthesis User
Digital Weight Bearing Shape Capture Socket Technology
The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability \& functional outcomes than traditional sockets…
- Conditions
- Amputation, Prosthesis User, Residual Limbs
- Trial name
- DWB (NCT05749952)
- Testing
- Symphonie Aqua Digital System mediated sh
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Indiana University
Amputation, Amputation; Traumatic, Leg, Lower
A Comparative Assessment of Transfemoral Prosthetic Sockets
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
- Trial name
- NCT04038580
- Testing
- Laminated Socket, Quatro, Infinite Socket
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- University of Michigan
Phantom Limb Pain, Amputation, Traumatic
Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)
This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four…
- Trial name
- NCT02487966
- Testing
- transcranial Direct Current Stimulation (tDCS): active (Soterix ©), Mirror Therapy: active
- Where
- 2 sites in United States, Brazil
- Volunteers
- 132 people
- Sponsor
- Spaulding Rehabilitation Hospital
Prosthesis User, Amputation
Clinical Investigation (Beta) of Power Knee Mainstream - Dynamic
Prospective two group cross over investigation, comparing the investigational device (Power Knee, a powered microprocessor controlled prosthetic knee) and subjects prescribed microprocessor prosthetic knee (MPK).
- Trial name
- NCT04787627
- Testing
- Power Knee
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Össur Iceland ehf
Amputation
Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs.
- Trial name
- NCT06468059
- Testing
- Layered Low Profile Foot, Prescribed Ankle
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Little Room Innovations, LLC
Amputation
Clinical Investigation (Beta) of a New Developed Prosthetic Knee
The aim of this investigation is to evaluate the efficacy of the investigational device regarding performance improvements and satisfaction in descending activities for moderate to high active prosthesis users within the intended…
- Trial name
- NCT06748729
- Testing
- Navii Knee
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Össur Iceland ehf
Amputation; Postoperative, Sequelae
Hyperbaric Oxygen and Outcome After Below Knee Amputations
This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications.
- Trial name
- NCT04717557
- Testing
- Hyperbaric Oxygen
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Duke University
Amputation
Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?
Previous studies suggest that Veterans with below the knee amputation using passive-elastic or powered prostheses have impaired physical function, which could increase the risk of osteoarthritis, leg/back pain, and…
- Trial name
- NCT03974945
- Testing
- Passive-elastic prosthetic foot, Powered ankle-foot prosthesis
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Amputation, Limb Deficiencies
Assessing the DSR Ankle
This research is being done to conduct a preliminary investigation into a new prosthetic microprocessor controlled (MPC) ankle, called the Damping, Stiffness, and Repositioning (DSR) ankle.
- Trial name
- NCT05955378
- Testing
- DSR Ankle, Predicate Ankle
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Synchro Motion LLC
Amputation Stump, Amputation
Moisture Management Liner At-Home Evaluation
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 unbreathable and non-thermally conductive materials that can create a warm…
- Conditions
- Amputation Stump, Amputation, Amputees, Lower Limb Deformity
- Trial name
- NCT05124873
- Testing
- Moisture Management Liner
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Liberating Technologies, Inc.
Post-Amputation Pain, Phantom Limb Pain
Electrical Nerve Block for Amputation Pain
The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
- Conditions
- Post-Amputation Pain, Phantom Limb Pain, Residual Limb Pain, Stump Pain
- Trial name
- NCT02221934
- Testing
- Altius
- Where
- 22 sites in United States
- Volunteers
- 607 people
- Sponsor
- Neuros Medical, Inc.
Amputation
Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study
The study investigated the perceived-mobility of patients with unilateral lower limb amputations by means of patient-reported outcome measures (PROMs).
- Trial name
- CP-PRO-01-20 (NCT05392907)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Upper Limb Amputation
Brasthesis Prosthetic Harness for Women Veterans With Upper Limb Amputations
This project tests Brasthesis, a new product for women Veterans with upper limb loss. Brasthesis incorporates the harnessing straps that hold the prosthesis to the body into a heavy-duty sports bra.
- Trial name
- Brasthesis (NCT05179395)
- Testing
- Brasthesis
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- VA Office of Research and Development
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness 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 Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Pain, Amputation
Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain
Participants with chronic, refractory phantom limb pain (PLP) or residual limb pain (RLP) for more than 6 months will be enrolled in this clinical trial.
- Trial name
- NCT05046639
- Testing
- 10 mL 2% lidocaine, 10 mL preservative free saline
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Northwestern University
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
Chronic Pain, Brain Injuries, Traumatic
Telehealth Pain Self-Management for Employed Adults
The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed.
- Conditions
- Chronic Pain, Brain Injuries, Traumatic, Multiple Sclerosis, Spinal Cord Injuries
- Trial name
- E-TIPS (NCT04248725)
- Testing
- E-TIPS
- Where
- United States
- Volunteers
- 220 people
- Sponsor
- University of Washington