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Amputation clinical trials

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NCT ID: NCT04030585 Completed - Amputation Clinical Trials

Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis

Start date: July 24, 2019
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the effect of a robot-assisted biofeedback exercise program on grip strength, movement speed, coordination, functional status, depressive status, and quality of life in patients with a myoelectric prosthesis with upper limb amputation. In the literature review, There is no robot-assisted exercise program applied in patients using upper extremity myoelectric prosthesis. The expected benefit from this study is to show that the functional status, depressive status, and quality of life of the patients who received robot-assisted biofeedback exercise were better than those who had a home exercise program only.

NCT ID: NCT04023578 Completed - Amputation Clinical Trials

An Investigation of Functional Improvements in the RHEO KNEE Compared to Hydraulic Microprocessor Controlled Knees (MPKs)

Start date: June 30, 2015
Phase: N/A
Study type: Interventional

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 X3) after 3 weeks of use. The primary objective of the study was to determine/investigate whether unilateral (TF) amputees can apply and benefit from the stair ascent function of the Rheo Knee XC and compare the stair ascent function and automatic cycling detection of the Rheo Knee XC to hydraulic microprocessor controlled knees (MPK-HY). The testing was conducted in a non-blinded, multicenter, prospective within subject comparison, with a subgroup analysis with Magneto-rheologic microprocessor controlled knees (MPK-MR) subgroup and MPK-HY subgroup comparing to the Rheo knee XC. A convenience sample of 15 transfemoral amputee users was recruited at 4 study sites. Inclusion criteria: - Cognitive ability to understand all instructions and questionnaires in the study; - Unilateral knee-disarticulated or transfemoral users fitted to Rheo Knee II,III or Genium - Willing and able to participate in the study and follow the protocol - Confident prosthetic users for more than 3 months - Older than 18 years Exclusion Criteria - Patients with the following characteristics are not eligible for study entry: - 50Kg> body weight > 136Kg - Users with cognitive impairment - Users not understanding the function of the knee - Users not able to charge the battery Testing was conducted between June and August 2015 in four US locations. Participants visited the study location twice, for approximately 3 hours per visit. First time for the baseline measure and initial fitting and secondly after 3 weeks of accommodation on the Rheo knee XC, performing the same measures as for the baseline. Measures included 6 minute walk test with Borg scale CR pre and post, L-test, stair assessment index, stair and bicycle evaluation and Prosthesis evaluation questionnaire mobility section (PEQ MS12/5) For statistics repeated measures analysis of variance (ANOVA) comparing baseline to 3 week follow up were performed.

NCT ID: NCT04018469 Withdrawn - Amputation Clinical Trials

Patterned Electric Dressing Effects on Open Wounds

PED
Start date: April 2022
Phase:
Study type: Observational [Patient Registry]

1. This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization. 2. The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization.

NCT ID: NCT04009187 Completed - Multiple Sclerosis Clinical Trials

A Wheelchair Propulsion Training Program

HS
Start date: March 27, 2018
Phase: N/A
Study type: Interventional

The overall purpose of this project is to test the feasibility of a manual wheelchair propulsion program which aims to reduce the chance of development of upper limbs pain and injury.

NCT ID: NCT03989063 Recruiting - Diabetes Mellitus Clinical Trials

Motor Learning in Individuals With Lower Limb Loss and Chronic Diabetes

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Inadequate rehabilitation training after amputation can result in poor patient outcomes, injuries, and wasted healthcare resources. This is a serious public health problem due to an aging population and rising prevalence of diabetes (main cause of amputation in the U.S.). In this study, the investigators will examine the effects of external vs. internal attentional focus instruction on learning of a balance task in individuals with existing amputation and those at risk of amputation (older adults with diabetes). With the proposed research, the investigators aim to expand the understanding of motor learning in individuals with and at risk of lower limb loss to provide knowledge that will lead to more effective and efficient rehabilitation.

NCT ID: NCT03974945 Recruiting - Amputation Clinical Trials

Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?

Start date: August 1, 2019
Phase:
Study type: Observational

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 diabetes/obesity. Utilization of rehabilitation strategies/techniques such as real-time visual feedback training could restore physical function, increase physical activity, and reduce injury risk. The investigators will systematically determine the effects of using real-time visual feedback training of peak propulsive (push-off) force during walking while Veterans with below the knee amputations use a passive-elastic and battery-powered prosthesis. Similar to previous studies of non-amputee older (>65 years) and post-stroke adults, use of real-time visual feedback training of propulsive force will likely improve walking function in Veterans with amputations. Such training presents a promising rehabilitation strategy that could reduce comorbidities, while improving quality of life, comfort, and physical function, and advancing rehabilitation research and prosthetic development.

NCT ID: NCT03965663 Not yet recruiting - Amputation Clinical Trials

Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees

Start date: July 2020
Phase: N/A
Study type: Interventional

The aim of the study is to investigate the influence of a vibro-tactile device on trans-tibial amputees in terms of gait, pain and perception of the prosthesis.

NCT ID: NCT03957226 Withdrawn - Amputation Clinical Trials

An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations

Start date: January 30, 2020
Phase: N/A
Study type: Interventional

This early feasibility study proposes to evaluate use of the electronic-Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) device, a transhumeral implant system for direct skeletal anchorage of amputation prostheses, with a test prosthesis. The e-OPRA System is being investigated to better understand the ability to improve the functionality of the prosthesis and enhance the sense of embodiment of the prosthesis itself. This will be a 10 subject Early Feasibility Study in which the primary objective is to capture preliminary safety and effectiveness information on the implanted e-OPRA system. With the addition of electrodes to the muscle segments, this biological interface allows for both the extraction of fine motor control signals from the nerve fascicles and the generation of sensory percepts via electrical stimulation of the muscles. In addition, electrodes placed on muscles within the residuum with native vascularization and innervation also allow the extraction of critical motor control signals and the generation of sensory feedback through muscle stimulation. The electrical activity recorded from these muscle segments (called electromyography or EMG) is specific to certain movements and can be used to determine precisely how a person wants to move their arm and hand. Use of the e-OPRA device with the well-documented neuro-electronic capabilities of EMG control systems provides an alternative to traditional socket prostheses by establishing a direct, loadbearing link between the patient's skeleton and prosthesis.

NCT ID: NCT03947450 Recruiting - Amputation Clinical Trials

Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

Start date: September 5, 2019
Phase: Phase 2
Study type: Interventional

This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.

NCT ID: NCT03934281 Completed - Amputation Clinical Trials

Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient

MELIDIAB
Start date: June 27, 2018
Phase: N/A
Study type: Interventional

Numerous scientific publications in France and internationally have described the healing, anti-bacterial, anti-oxidant, anti-inflammatory and immuno-modulating properties of honey. Honey is effective in the management of many infected or uninfected post-surgical wounds. This study focuses on post surgical wounds after toe amputation in diabetic patients. The main objective of this study is to compare the rate of epidermisation at six months for these wounds, between honey dressing and other dressing devices used according to the french Haute Autorité de Santé (HAS) recommendations