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Amputation clinical trials

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NCT ID: NCT04775667 Completed - Amputation Clinical Trials

Kinesiophobia and Associated Factors in Patients With Traumatic Lower Extremity Amputation

Start date: March 1, 2021
Phase:
Study type: Observational

There are limited studies examining kinesiophobia and factors associated with kinesophobia in patients with lower limb amputation. The aim of this study is to illustrate the level of kinesiophobia in patients with traumatic lower extremity amputation and to analyze the correlation between kinesiophobia and associated factors (pain, prosthesis satisfaction, fear of fall, quality of life). This cross-sectional study will involve 52 patients with traumatic lower extremity amputation. Kinesiophobia level will be measured with the Tampa Scale for Kinesiophobia (TSK). All patients will point the severity of sound limb pain, residual limb pain, low back pain and the overall prosthesis, socket system and prosthetic foot satisfaction on a Visual Analogue Scale (VAS). Falls Efficacy Scale-International (FES-I) will be used for evaluation of falls efficacy under different circumstances. The quality of life (QoL) will be assessed with Nottingham Health Profile (NHP).

NCT ID: NCT04759014 Completed - Amputation Clinical Trials

The Effect of Using Two Different Prosthetic Feet in Patients With Unilateral Transtibial Amputation

Start date: February 18, 2021
Phase:
Study type: Observational

Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data. Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation.

NCT ID: NCT04756752 Completed - Amputation Clinical Trials

Effect of Sports-oriented Rehabilitation on Mobility and Daily Activity in People With a Lower-limb Amputation

Start date: August 6, 2019
Phase:
Study type: Observational

Mobility is one of the most important factors in the quality of life of people with a lower-limb amputation. However, mobility and physical activity are often limited. 61% of amputees is not sufficiently active in daily life and only about 15% of the Dutch amputees regularly participates in sports. Physical inactivity is known to increase the risk of comorbidities, especially among amputation patients who already have a higher prevalence of vascular diseases, diabetes and osteoarthritis. It is clear that sufficient daily physical activity is important to optimize the health and quality of life of amputees. Research has shown that higher aerobic capacity, higher muscle force and the absence of comorbidities are related to better walking ability, as walking is more energy consuming for people with an amputation. It is therefore expected that increasing strength and cardiovascular fitness results in better mobility, higher daily activity, better physical health and a better quality of life among amputees. To improve physical capacity and sports participation in people with a lower-limb amputation, the Sint Maartenskliniek (Nijmegen, The Netherlands) and Dutch football club N.E.C. Nijmegen developed a new exercise program: Fit en Vitaal. Participants perform a six-week training program with three training sessions each week (fitness, aqua-fitness and a sports and play session) under the guidance of movement agogue. Thereafter, they continue with a low-frequency movement intervention during which they attend various sports clinics once a week for eight months. As social support and contact with peers are important factors in sports participation for amputees, the Fit en Vitaal program was designed as a yearly returning program with a fixed group of participants at the start of each year. This exploratory study aimed to evaluate both the direct and indirect effects of the Fit en Vitaal program on people with a lower-limb amputation in terms of walking ability, functional mobility, oxygen consumption during walking, daily physical activity at home and experienced quality of life. It is expected that all will improve after the first six weeks of training, and the effects will remain after the eight-month low-frequency training.

NCT ID: NCT04692571 Completed - Amputation Clinical Trials

EMG-Based Hand-Wrist Control: Study B Mirrored

PSICON-B
Start date: June 29, 2017
Phase: Early Phase 1
Study type: Interventional

Study assessing four-channel prosthesis controller, that compares contralateral (mirrored) EMG-force training to ipsilateral EMG-target training with both limb-absent and able-bodied subjects

NCT ID: NCT04595071 Completed - Amputation Clinical Trials

Functional Outcomes of Voice Recognition Prosthesis

Start date: November 13, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the use of a voice activated prosthesis interface controller for functional outcomes as compared to standard prosthesis control.

NCT ID: NCT04588753 Completed - Amputation Clinical Trials

Active Isolated Stretch and Post Facilitation Stretch on Hamstring Flexibility in Trans-tibial Amputees.

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

The aim of this study is to examine the effect of two techniques on hamstrings flexibility in trans-tibial amputees. Reduced flexibility can cause insufficiency at the workplace. Increasing flexibility is to decrease risk of injury, enhances performance and incorporate rehabilitation programs . Further studies are still needed in order to enhance patient rehabilitation protocol and anticipate the prosthetic process. Evidence based Physical therapy could be considered a valid support improving knee contractures in patients with trans-tibial amputation.This research provide an important addition to the evidence-based treatment intervention of physical therapy in amputees rehabilitation as no comparative study between Active Isolated Stretch and Post Facilitation Stretch on hamstring flexibility is done in trans-tibial Amputees.

NCT ID: NCT04484805 Completed - Amputation Clinical Trials

Socket Cooling Effectiveness Take Home Study

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

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 and ultimately moist environment. To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.

NCT ID: NCT04427007 Completed - Amputation Clinical Trials

Moisture Management Liner Effectiveness Study

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

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 and ultimately moist environment. The investigators have developed a silicone liner approach to remove sweat from the skin and out of the socket and to passively conduct heat from the skin using thermally conductive elastomers. This liner has been developed to work alongside a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE) developed in a parallel project by Vivonics, Inc. and Liberating Technologies, Inc. The ICE device can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight, and other prosthetic characteristics would benefit many prosthesis wearers.

NCT ID: NCT04422717 Completed - Amputation Clinical Trials

Femoral Cartilage Thickness In Patients With Lower Limb Amputation

Start date: February 15, 2019
Phase:
Study type: Observational [Patient Registry]

The aim of the study to investigate any relation with functional parameters and femoral cartilage thickness evaluation by ultrasonography in lower extremity amputate individuals.

NCT ID: NCT04354493 Completed - Amputation Clinical Trials

Myoelectric Game Training and Outcomes

Start date: April 4, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of myo-electric training tools on prosthesis functional outcomes.