Clinical and Psychological Adjustment of Patients With LLA: a Multidisciplinary Rehabilitative Intervention Project

NCT06471855 | Recruiting

• 1 other identifier: 2768
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Amputation; Prosthesis User

Keywords

Amputee; Multidisciplinary rehabilitation; HRQoL; Psychological adaptation; Usability; HT/robotic rehabilitation; Psychoeducation

Outcome Measures

Primary Outcomes (15)

• Short-term changes in Modified Barthel Index (MBI)

  The Modified Barthel Index (MBI) evaluates patient's autonomy to perform ADLs (ie, chair/bed transfer, ambulation, stair climbing, toilet transfer, bowel control, bladder control, bathing, dressing, personal hygiene, feeding). Total scores range from 0 to 100. Higher scores indicate higher patient's autonomy.

  From baseline (T0) to 3 weeks of rehabilitation (T1)

• Short-term changes in Morse Fall Scale (MFS)

  The Morse Falls Scale (MFS) evaluates patient's risk of falls. Total scores ranges from 0 to 125 with higher scores reflecting a greater risk of falling.

  From baseline (T0) to 3 weeks of rehabilitation (T1)

• Short-term changes in Functional Independence Measure (FIM)

  The Functional Independent Measure (FIM) evaluates patient's disability level according to motor and cognitive subscores. Total scores range from 18 (complete dependence) to 126 (complete independence). Two subscores can be calculated: FIM motor (range 13-91) and FIM cognitive (range 5-35).

  From baseline (T0) to 3 weeks of rehabilitation (T1)

• Short-term changes in Timed Up & Go Test (TUG)

  The Timed Up \& Go Test measures patient's risk of falling, static and dynamic balance by estimating the time patient takes to stand up from an armchair, walk forward for 3 meters, turn, walk back to the chair and sit down. The longer the time this takes, the higher the risk of falling.

  From baseline (T0) to 3 weeks of rehabilitation (T1)

• Short-term changes in Visual Analogue Scale (VAS)

  The Visual Analogue Scale (VAS) measures patient's subjective perceived pain with a visual representation. Total scores range from 0 to 10. Higher scores indicate more severe pain.

  From baseline (T0) to 3 weeks of rehabilitation (T1)

• Amputee Mobility Predictor (AMP)

  Amputee Mobility Predictor (AMP): it is a well known tool that clearly assesses the functional status of the amputee. It is composed of 21 items, each divided in 3 scoring choices: 0 indicates inability to perform the task; 1 implies minimal level of achievement or that some assistance was required in completing the task and 2 denotes complete independence or mastery of the task. The items must be submitted with an increasing level of difficulty to allow for the progressive assessment of the amputee. In particular, the evaluation goes from the ability to maintain sitting balance, gradually increasing the difficulty level of the activities to the final steps which are about collecting data during gait and during the use of particular assistive devices. The total score range for the AMP is 0 to 42 points.

  3 weeks of rehabilitation (T1)

• The Mini Mental State Examination (MMSE)

  The Mini Mental State Examination (MMSE) screening test evaluates the patient's cognitive functions (ie, sense of orientation, memory, attention, language function, visual-spatial abilities, the ability to count, remember things, repeat and execute orders). Total scores range from 0 to 30. Lower scores indicate more severe cognitive disorders.

  Baseline (T0)

• The Personality Inventory for the DSM-5 - Short Version (PID-5-BF)

  The Personality Inventory for the DSM-5 - Short Version (PID-5-BF) evaluates personality trait assessment (ie, Negative Affectivity, Detachment, Antagonism, Disinhibition and Psychoticism). Total scores range from 0 to 75. Higher scores indicate more dysfunction in the specific personality trait domain.

  Baseline (T0)

• The Antecedents and Self-Efficacy on Adherence Schedule (ASonA)

  The Antecedents and Self-Efficacy on Adherence Schedule (ASonA) evaluates the antecedents (ie, health literacy, understanding of illness, perception of social support, acceptance of health-related limitations), the self-efficacy (the beliefs and self-care strategies on adherence for physical activity, diet, alcohol consumption and smoking avoidance) and the affectivity (the emotional response related to health status). Total scores range from 0 to 84. High scores correspond to higher perceived self-efficacy in the investigated domains.

  Baseline (T0)

• Short-term changes in EuroQoL-VAS (EQ-VAS)

  The EuroQoL-VAS (EQ-VAS) evaluates self-rated health on a vertical visual analogue scale (0: the worst health you can imagine; 100: the best health you can imagine). Higher scores indicate better health-related quality of life.

  From baseline (T0) to 3 weeks of rehabilitation (T1)

• Short-term changes in Generalized Anxiety Disorder-7 (GAD-7)

  The Generalized Anxiety Disorder-7 (GAD-7) evaluates anxiety symptoms severity in the last 2 weeks. Total scores range from 0 to 21. Higher scores indicate more severe anxiety.

  From baseline (T0) to 3 weeks of rehabilitation (T1)

• Short-term changes in Patient Health Questionnaire-9 (PHQ-9)

  The Patient Health Questionnaire-9 (PHQ-9) evaluates depression symptoms severity in the last 2 weeks. Total scores range from 0 to 21. Higher scores indicate more severe depression.

  From baseline (T0) to 3 weeks of rehabilitation (T1)

• Short-term changes in Body Image Scale (BIS)

  The Body Image Scale (BIS) evaluates the alteration of the body image. Total scores range from 0 to 30. Higher scores indicate more distress symptoms.

  From baseline (T0) to 3 weeks of rehabilitation (T1)

• The Trinity Amputation and Prosthesis Experience Scales (TAPES)

  The Trinity Amputation and Prosthesis Experience Scales (TAPES) evaluates prosthesis experience and adaptation (ie, general adaptation, social adaptation, adaptation to limitation, functional satisfaction, aesthetic satisfaction, weight satisfaction of the prothesis). This instrument also includes a final section analysing the presence of phantom limb and stump pain, and other medical issues. Total scores range from 25 to 125. Higher scores indicate a worse adaptation.

  3 weeks of rehabilitation (T1)

• The Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q)

  The Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) is an ad-hoc questionnaire measuring patients' experience of use of the devices (ie, technology learnability, acceptability, usefulness, adaptability, adverse effects, engagement, enjoyment, safety, perceived effectiveness). Total scores range from 10 to 40. Higher scores indicate better patient's experience of use of the devices.

  3 weeks of rehabilitation (T1)

Study Arms (2)

Technology-based Rehabilitation Group

EXPERIMENTAL

Patients will undergo conventional treatment and, additionally, virtual reality-based rehabilitation.

Device: Multidisciplinary Conventional and Technology-based Rehabilitation

Conventional Rehabilitation Group

ACTIVE COMPARATOR

Patients will undergo conventional treatment exclusively.

Other: Multidisciplinary Conventional Rehabilitation

Interventions

Multidisciplinary Conventional and Technology-based Rehabilitation DEVICE

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.

Technology-based Rehabilitation Group

Multidisciplinary Conventional Rehabilitation OTHER

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.

Conventional Rehabilitation Group

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri, IRCCS

Pavia, PV, 27100, Italy

RECRUITING

Study Officials

• Antonia Dr Pierobon

  Istituti Clinici Scientifici Maugeri, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Dr Pierobon

CONTACT

+390385247255; antonia.pierobon@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel, randomized prospective quasi-experimental study design

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: June 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IT (1)