Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471855
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-18
Brief Title:
Clinical and Psychological Adjustment of Patients With LLA a Multidisciplinary Rehabilitative Intervention Project
Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Organization:
Istituti Clinici Scientifici Maugeri SpA
Study Overview
Official Title:
Clinical and Psychological Adjustment of Patients With Lower Limb Amputation a Multidisciplinary Rehabilitative Intervention Project AMP_ADinRehab Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMPADinRehab
Brief Summary:
Most of the limb amputation related to vascular disease is often secondary to a diagnosis of type 2 diabetes mellitus The amputation involves significant motor psychological and social challenges for patients with a major effect on their psycho-physical health The psychological processes that characterize this clinical population are still poorly investigated Adopting a biopsychosocial approach the present randomized prospective quali-quantitative study protocol aims to evaluate the behavioural and psychological adaptation at various stages of the disease risk of amputation lower limb amputation and prosthesis use In the last phase patients with prosthesis will receive traditional rehabilitation treatment and technology-based rehabilitation experimental or not active comparator with randomized controlled enrolment The evaluation will be based on a semi-structured interview specific to the disease stage and constructed using the Three Factor Model and rating scales Patients medical history functional status ie motor functionality autonomy in BIM and FIM risk of falls subjective perceived pain and psychological aspects ie emotional impact HRQoL anxiety and depression symptoms personality traits acceptance adherence body image the experience of the prosthesis and technology-based rehabilitation expectations for the future will be investigated The audio-recorded and transcribed interviews will be analyzed using the Interpretive Description approach
Detailed Description:
It has been shown in the literature that most lower limb amputations are due to diseases related to vascular problems and diabetes with different incidences depending on geographical region and ethnicity There are various levels of lower limb amputation LLA from the fingertips or tarsal area trans-tibial amputations which involve the removal of part of the tibia and fibula trans-femoral amputations which are at the level of the femur and hip amputations Scientific literature and clinical experience suggest that the loss of a limb through amputation has a major impact on quality of life and physical and psychological well-being Important are the repercussions on mobility and specifically the inability to walk has a negative impact on the performance of basic daily activities and reintegration into society Amputation can also produce emotional disorders leading to a change in levels of anxiety depression and pain generating significant changes in the persons quality of life Self-acceptance of a person with lower limb amputation is seen as a complex process in which the prosthesis plays the role of a life-enhancing tool Indeed the prosthesis allows people to return to living life normally increase their quality of life and restore their body image Rehabilitation programs for amputees all have a common aim which is to improve peoples mobility and general functioning through the use of the prosthesis that promote reintegration into the community and the overall improvement of these peoples quality of life In fact the use of a prosthesis has a great effect on these patients as it attempts to contrast the negative impact of lower limb amputation in various areas physical psychological and social The prosthesis is considered not only as an enabling device but also as a central component for personal and social identity Over the last 20 years rehabilitation has increasingly started to use high-tech components such as robotic and virtual reality rehabilitation both immersive and non-immersive The use of technological components not only constitutes an innovative accessible and increasingly useful treatment tool but is also recognized as an added value to traditional rehabilitation due to the positive impact it has on activities of daily living Rehabilitation with virtual reality consists of the integration to traditional rehabilitation practice of high-tech devices that allow multisensory stimulation and interaction with virtual environments that simulate situations and contexts of daily life at different levels of immersion
The psychological processes characterizing this clinical population are still poorly investigated and here are few studies using rehabilitation with high-tech instruments on patients with prostheses after LLA
Following this line the purpose of this prospective study protocol is to explore changes and evolutions in the psychological and behavioural adaptation constructs in patients at high vascular risk of LLA already amputated or undergoing prosthesis adaptation these ones receiving traditional rehabilitation treatment and technology-based rehabilitation experimental or not active comparator with randomized controlled enrolment This quali-quantitative study project comes from the need to have a holistic vision of the patient acceptance process in the various phases of the disease and of the factors involved in the process of adaptation to the prosthesis analyzing the state of health
Specifically the study objectives are
1 to analyze HRQoL psychological and behavioral adaptation in patients at high vascular risk of LLA already amputated or undergoing prosthesis adaptation
2 to present a multidisciplinary rehabilitation intervention model traditional rehabilitation vs traditional rehabilitation with technology-based rehabilitation and study its impact on the HRQoL in patients with prostheses only trans-tibial amputations
The psychological processes characterizing this clinical population are still poorly investigated and here are few studies using rehabilitation with high-tech instruments on patients with prostheses after LLA
Following this line the purpose of this prospective study protocol is to explore changes and evolutions in the psychological and behavioural adaptation constructs in patients at high vascular risk of LLA already amputated or undergoing prosthesis adaptation these ones receiving traditional rehabilitation treatment and technology-based rehabilitation experimental or not active comparator with randomized controlled enrolment This quali-quantitative study project comes from the need to have a holistic vision of the patient acceptance process in the various phases of the disease and of the factors involved in the process of adaptation to the prosthesis analyzing the state of health
Specifically the study objectives are
1 to analyze HRQoL psychological and behavioral adaptation in patients at high vascular risk of LLA already amputated or undergoing prosthesis adaptation
2 to present a multidisciplinary rehabilitation intervention model traditional rehabilitation vs traditional rehabilitation with technology-based rehabilitation and study its impact on the HRQoL in patients with prostheses only trans-tibial amputations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None