Clinical trial NCT06471855: Clinical and Psychological Adjustment of Patients With LLA: a Multidisciplinary Rehabilitative Intervention Project
Official title: Clinical and Psychological Adjustment of Patients With Lower Limb Amputation: a Multidisciplinary Rehabilitative Intervention Project (AMP_ADinRehab Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Limb Amputation
Prosthesis User
Keywords: Amputee
Multidisciplinary rehabilitation
HRQoL
Psychological adaptation
Usability
HT/robotic rehabilitation
Psychoeducation
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 70
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel, randomized prospective quasi-experimental study design
Primary purpose: TREATMENT

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. Patient's 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 person's 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 people's mobility and general functioning through the use of the prosthesis, that promote reintegration into the community and the overall improvement of these people's 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).

Eligibility criteria: Inclusion Criteria:

* Risk of amputation or Lower limb amputation or prothesis use for vascular disease and diabetes type 2

Exclusion Criteria:

* more than 80 years older
* severe clinical condition (ie, chronic heart failure \[New York Heart Association Classification-IV - NYHA-IV\], ischemic heart disease \[Canadian Cardiovascular Society Classification-IV - CCS-IV\], neoplastic disease, acute respiratory disease);
* non-Italian education
* severe visual-perceptive deficits
* severe cognitive impairment (MMSE ≤ 26 Foderaro et al, 2022);
* severe mental health condition or psychiatric disorder compromising participation in the study;
* absence or withdrawal of the informed consent to participate.

Primary outcomes:
measure: Short-term changes in Modified Barthel Index (MBI)
timeFrame: From baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Short-term changes in Morse Fall Scale (MFS)
timeFrame: From baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Short-term changes in Functional Independence Measure (FIM)
timeFrame: From baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Short-term changes in Timed Up & Go Test (TUG)
timeFrame: From baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Short-term changes in Visual Analogue Scale (VAS)
timeFrame: From baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Amputee Mobility Predictor (AMP)
timeFrame: 3 weeks of rehabilitation (T1)
measure: The Mini Mental State Examination (MMSE)
timeFrame: Baseline (T0)
measure: The Personality Inventory for the DSM-5 - Short Version (PID-5-BF)
timeFrame: Baseline (T0)
measure: The Antecedents and Self-Efficacy on Adherence Schedule (ASonA)
timeFrame: Baseline (T0)
measure: Short-term changes in EuroQoL-VAS (EQ-VAS)
timeFrame: From baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Short-term changes in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: From baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Short-term changes in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: From baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Short-term changes in Body Image Scale (BIS)
timeFrame: From baseline (T0) to 3 weeks of rehabilitation (T1)
measure: The Trinity Amputation and Prosthesis Experience Scales (TAPES)
timeFrame: 3 weeks of rehabilitation (T1)
measure: The Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q)
timeFrame: 3 weeks of rehabilitation (T1)
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri, IRCCS
state: PV
Study officials:
affiliation: Istituti Clinici Scientifici Maugeri, IRCCS
name: Antonia Dr Pierobon
role: PRINCIPAL_INVESTIGATOR
References: