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Lower Limb Amputation clinical trials

View clinical trials related to Lower Limb Amputation.

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NCT ID: NCT04293237 Completed - Clinical trials for Lower Limb Amputation

Metric Charcteristics of Sit-to-stand Tests in Patients After Lower-limb Amputation

STST
Start date: February 26, 2020
Phase:
Study type: Observational

The aim of the study is to assess various aspects of reliability and validity of two sit-to-stand tests, the Five Times Sit to Stand Test (5TSTS) and the 30-Second Sit to Stand Test (30SSTS). The tests will be performed by patients after lower-limb amputation who have been newly fitted with a prosthesis. Each test will be performed with and without the prosthesis on two occasions: on the first day when the patients will be able to walk independently with their prosthesis and two weeks later. On the same two occasions, the patients will also perform three walking tests (in randomised order): the L-test, the 10-Metre Walk Test and the 6-Minute Walk Test. In addition, the patients will repeat the 5TSTS and the 30SSTS one day after the first assessment. The results will be used to detect the presence of a floor effect, assess repeatability and concurrent validity, as well as estimate minimal detectable change and effects size for the effect of rehabilitation.

NCT ID: NCT04285138 Completed - Clinical trials for Lower Limb Amputation

Phantom Exercise for Lower Limb Amputees

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

In this research, the aim is to find out the effects of phantom exercises in terms of pain, mobility and quality of life among lower-limb amputees having phantom limb pain. This is a randomized control trial in which amputees having phantom limb pain will be randomly divided into two groups i.e. Experimental group (Routine physical therapy, mirror therapy and phantom exercises) and control group (Routine physical therapy and mirror therapy). Non-probability purposive sampling technique will be employed. Patients of age between 18 to 50 years and having phantom limb pain after lower limb amputation will be recruited by evaluating with limb deficiency and phantom limb questionnaire. Other tools will be Visual analogue scale (pain), Amputee mobility predictor (Ambulatory status) and 36-Item Short-Form Health Survey questionnaire (Health-related quality of life). The study will be conducted in 6 months and data obtained will be analyzed through Statistical Package for Social Sciences (SPSS) 20.

NCT ID: NCT04275973 Recruiting - Clinical trials for Lower Limb Amputation

Evaluating Mobility Interventions in the Real World

Start date: September 3, 2021
Phase: N/A
Study type: Interventional

This study is intended to test the comparative biomechanical benefits of different lower-limb prostheses and orthoses using data collected over extended periods of everyday life using wearable sensors. Investigator seek to improve physical health, functional activity level, independence, workforce participation, and mental health in participants with lower limb amputation and other lower-limb impairments. Investigator seek to study the similarities and differences in participants' movement using prostheses and orthoses with different technological features or designs. Study team also seek to develop technologies that enhance the methods for using wearable sensor technology to perform this type of study. Participants with lower-limb amputation, participants who use lower limb orthoses, participants with drop-foot (including a specific group with Multiple Sclerosis), and healthy control participants will be recruited in this study.

NCT ID: NCT04141748 Completed - Clinical trials for Lower Limb Amputation

Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The overall objective is to compare hand casting to standing hydrostatic pressure casting using a water cylinder in persons with lower limb amputation. Our overall hypothesis is that standing hydrostatic pressure casting with a water cylinder will lead to more consistent and efficient residual limb shape capture and improved initial socket fit and comfort compared to hand casting.

NCT ID: NCT04086069 Withdrawn - Clinical trials for Lower Limb Amputation

Sit-to-stand Trainer in Patients After Lower Limb Amputation

STSTrainer
Start date: February 6, 2019
Phase: N/A
Study type: Interventional

The study will include rehabilitation inpatients after unilateral lower limb amputation who are candidates for walking with a prosthesis. Those in the experimental group will receive training using a sit-to-stand trainer device in addition to standard training of standing-up with the help of a physiotherapist. Those in the control group will only receive the standard training. The effects of the rehabilitation programme will be assessed using the 30-Second Chair Stand Test before the start of the training and after 10 days of training. For the first five patients from each group who will be able to stand up with the use of hands, detailed kinesiological analysis of standing-up pattern will be performed.

NCT ID: NCT04030650 Recruiting - Clinical trials for Lower Limb Amputation

Study of Locomotor Expectations for Ascending/Descending Slope and Stairs in Patients With Limb Amputations

JCE
Start date: September 20, 2019
Phase:
Study type: Observational

Patients with lower limb amputations are equipped with prostheses that can be mechanical and/or electronic. These prostheses can be mono-articular (only the ankle) or bi-articular (knee and ankle for example). For amputee patients, situations that may seem trivial, such as climbing and descending stairs, become complex. Thus during the descent of stairs, an unamputated person will slow down the descent by contracting the thigh muscles, which are obviously lacking in the amputee patient. Current prostheses, known as "intelligent" (or "microprocessor") prostheses, make it possible to adjust the locomotion only once the first step has been taken and to assist the patient during ascent/descent situations on slopes and stairs. The next technological challenge in the development of lower limb equipment is to be able to anticipate these complex environmental situations, in order to secure and facilitate movement even before the obstacle is crossed or the terrain changed. This project plans to use the locomotor expectations commonly made during walking as a means of regulating the locomotor pattern. We believe that these expectations will depend on the situation, i.e. a particular anticipation when climbing or descending a slope, or when approaching a staircase, etc. To understand and describe these locomotor expectations, we plan to use recent techniques called supervised machine learning. These will make it possible to classify locomotor behaviour when walking on a slope or stairs. In the second phase, we would like to describe precisely the characteristics of the movements of the joints, and of the muscles during these adaptations. The final objective of this work is to create an autonomous sensor system to control the anticipatory behaviour of a lower limb prosthesis.

NCT ID: NCT03927404 Completed - Clinical trials for Lower Limb Amputation

Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health

DoD
Start date: February 12, 2020
Phase: N/A
Study type: Interventional

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. The prosthetic suspension plays a pivotal role in an amputee's comfort. It can also significantly impact an amputee's limb health. If the prosthesis is not held securely to the amputee's limb, relative movement between the limb and prosthetic interface can cause bruising, skin irritation and skin breakdown. These poor outcomes are uncomfortable and can lead to much more serious health conditions. A positive solution to creating secure and comfortable suspension is the use of a vacuum suspension socket. The vacuum pressure assists in preventing movement in the socket. The clinical benefits associated with vacuum suspension include volume retention, increased proprioception, secure suspension, and frequently reported observations of wound healing. However, the long term effects of vacuum suspension on circulation remain undetermined or undocumented. This study examines a vacuum suspension system on the health of the residual limb (amputated limb). A vacuum socket creates a vacuum between the rigid prosthetic socket and prosthetic liner which is sealed to the socket. Therefore, vacuum is not directly applied to the skin of the residual limb.

NCT ID: NCT03409354 Completed - Stroke Clinical Trials

Tele-Rehabilitation Pilot Evaluation Study

Start date: May 15, 2018
Phase: N/A
Study type: Interventional

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. The previous RCT was also limited to stroke patients. In addition to stroke, there are many other conditions (such as fractures, lower limb joint replacement, musculoskeletal conditions) require and benefit from rehabilitation. The primary aims of the pilot evaluation study are: (i) To document patient adherence to TR, compared to usual care (ii) To estimate the extent to which TR improves functional status, compared to usual care and (iii) To estimate the cost effectiveness of TR, compared to usual care in eight different health conditions in Singapore.

NCT ID: NCT03260530 Completed - Clinical trials for Lower Limb Amputation

Overall Functional Evaluation After Amputation of the Lower Limb; Locomotion, Energy Efficiency and Strategies to Adapt to the Prosthesis

PROTEOR
Start date: May 5, 2017
Phase:
Study type: Observational

It appears necessary to confront the reality of the contribution of technological progress in the creation of prostheses with the specific features of lower limb amputees. These contributions must be clearly identified in their different functional dimensions. This justifies a quantitative approach to the locomotor abilities of these patients, with regard to bioenergy parameters (consumption of oxygen while walking) and motor biomechanical parameters (quantified analysis of movement), so as to measure the real impact of the proposed prosthesis technology, as a complement to classical qualitative approaches. In this context, Dijon CHU, thanks to its Technological Investigation Platform (PIT, CIC 1432), and the company PROTEOR established a research partnership aiming to: - Refine the indications for the prescription of new products, by ensuring that they correspond to the profiles of the patients concerned and their true needs, - Study the underlying adaptive mechanisms, and establish new recommendations for their use, depending on the profiles of the users, - And ultimately, better evaluate, in a more rigorous and systematic manner, the prostheses available on the market. The research protocol presented in this document aims to provide a framework for part of the explorations that will be conducted in the context of this partnership. Lower-limb amputees who will be evaluated in this research will wear these prostheses (foot and/or knee prostheses), which bear the CE logo, and thus present all of the safety and performance conditions required for their use by these patients (prostheses destined for usual prescriptions), the objective of the study was not to evaluate the prostheses as such, but to explore and quantify the impact of these prostheses and their eventual modifications on the locomotor abilities of the patients concerned. The investigations will be conducted using non-invasive evaluation tools available on the PIT platform, with no modification in the usual management of these voluntary patients.

NCT ID: NCT02572011 Terminated - Clinical trials for Lower Limb Amputation

Transtibial Amputee Balance Training: A Randomised Controlled Trial

Start date: December 2015
Phase: N/A
Study type: Interventional

Lower limb amputees have reduced joint mobility and strength which negatively influence an individual's ability to maintain balance. Individuals with lower limb amputation also have an increased fear of falling and reduced social participation because of this fear. Improving balance ability, reducing falls and fear of falling through effective balance training interventions would have a number of socio-economic benefits. The aim of the current study is to investigate whether taking part in a games console based-balance intervention, improves balance ability in individuals with lower limb amputation.