Clinical and Psychological Adjustment of Patients With Lower Limb Amputation: a Multidisciplinary Rehabilitative Intervention Project (AMP_ADinRehab Study)
Clinical and Psychological Adjustment of Patients With LLA: a Multidisciplinary Rehabilitative Intervention Project
Sponsors
Source
Istituti Clinici Scientifici Maugeri SpA
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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).
Overall Status
Recruiting
Start Date
2023-06-01
Completion Date
2027-06-01
Primary Completion Date
2027-01-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Short-term changes in Modified Barthel Index (MBI) |
From baseline (T0) to 3 weeks of rehabilitation (T1) |
|
Short-term changes in Morse Fall Scale (MFS) |
From baseline (T0) to 3 weeks of rehabilitation (T1) |
|
Short-term changes in Functional Independence Measure (FIM) |
From baseline (T0) to 3 weeks of rehabilitation (T1) |
|
Short-term changes in Timed Up & Go Test (TUG) |
From baseline (T0) to 3 weeks of rehabilitation (T1) |
|
Short-term changes in Visual Analogue Scale (VAS) |
From baseline (T0) to 3 weeks of rehabilitation (T1) |
|
Amputee Mobility Predictor (AMP) |
3 weeks of rehabilitation (T1) |
|
The Mini Mental State Examination (MMSE) |
Baseline (T0) |
|
The Personality Inventory for the DSM-5 - Short Version (PID-5-BF) |
Baseline (T0) |
|
The Antecedents and Self-Efficacy on Adherence Schedule (ASonA) |
Baseline (T0) |
|
Short-term changes in EuroQoL-VAS (EQ-VAS) |
From baseline (T0) to 3 weeks of rehabilitation (T1) |
|
Short-term changes in Generalized Anxiety Disorder-7 (GAD-7) |
From baseline (T0) to 3 weeks of rehabilitation (T1) |
|
Short-term changes in Patient Health Questionnaire-9 (PHQ-9) |
From baseline (T0) to 3 weeks of rehabilitation (T1) |
|
Short-term changes in Body Image Scale (BIS) |
From baseline (T0) to 3 weeks of rehabilitation (T1) |
|
The Trinity Amputation and Prosthesis Experience Scales (TAPES) |
3 weeks of rehabilitation (T1) |
|
The Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) |
3 weeks of rehabilitation (T1) |
Enrollment
70
Conditions
Intervention
Intervention Type
Device
Intervention Name
Description
Patients will receive conventional treatment consisting of two daily sessions (3 weeks)
and including traditional rehabilitation activities like range of motion exercises
(passive, active assisted, and active), progressive resistive exercises, balance and
strength training, and aerobic conditioning. The intervention procedures will follow the
routine multidisciplinary clinical practice of the Institute where the study will be
carried out. According to their individualized rehabilitation project, patients will
undergo non-immersive VR-based rehabilitation. VR-based rehabilitation will consist of
one daily session (3 weeks) and will be conducted by the implementation of a single
non-immersive VR device among the D-WallTM (TechnoBody SRL, Italy). Part of the duration
of the whole treatment will be dedicated to the use of the device, resulting in the same
amount of rehabilitation for all participants.
Arm Group Label
Technology-based Rehabilitation Group
Intervention Type
Other
Intervention Name
Description
Patients will receive conventional treatment consisting of two daily sessions (3 weeks)
and including traditional rehabilitation activities like range of motion exercises
(passive, active assisted, and active), progressive resistive exercises, balance and
strength training, and aerobic conditioning. The intervention procedures will follow the
routine multidisciplinary clinical practice of the Institute where the study will be
carried out. Procedures will be adapted according to the patient's medical diagnosis,
disability severity, and to consequent rehabilitation objectives in favor of an
individualized rehabilitation project and program. If necessary, patients might therefore
undergo parallel rehabilitation activities (ie, occupational therapy, cognitive
stimulation) that will be kept under control throughout data collection and analyses.
Arm Group Label
Conventional Rehabilitation Group
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.
Gender
All
Minimum Age
N/A
Maximum Age
80 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Antonia Dr Pierobon |
Principal Investigator |
Istituti Clinici Scientifici Maugeri, IRCCS |
Overall Contact
Last Name
Antonia Dr Pierobon
Phone
+390385247255
antonia.pierobon@icsmaugeri.it
Location
Facility |
Status |
Contact |
|
Istituti Clinici Scientifici Maugeri, IRCCS Pavia PV 27100 Italy |
Recruiting |
Last Name: Antonia Dr Pierobon Phone: +390385247255 Email: antonia.pierobon@icsmaugeri.it |
Location Countries
Country
Italy
Verification Date
2026-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Number Of Arms
2
Arm Group
Arm Group Label
Technology-based Rehabilitation Group
Arm Group Type
Experimental
Description
Patients will undergo conventional treatment and, additionally, virtual reality-based
rehabilitation.
Arm Group Label
Conventional Rehabilitation Group
Arm Group Type
Active Comparator
Description
Patients will undergo conventional treatment exclusively.
Firstreceived Results Date
N/A
Acronym
AMPADinRehab
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Two-arm, parallel, randomized prospective quasi-experimental study design
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
June 18, 2024
Study First Submitted Qc
June 18, 2024
Study First Posted
June 24, 2024
Last Update Submitted
February 20, 2026
Last Update Submitted Qc
February 20, 2026
Last Update Posted
February 23, 2026
ClinicalTrials.gov processed this data on August 07, 2026
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.