Virtual Reality in the Rehabilitation in Patients With Lower Limb Amputation.

Study Overview
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Brief Summary
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The goal of this clinical trial is to test the impact of virtual reality on rehabilitation for the patients after a major amputation. The main questions it aims to answer are: Does the virtual-reality-assisted rehabilitation improve the life quality of patients (i.e. lesser pain, better spirit)? Does the virtual-reality-assisted rehabilitation improve the daily life function of the patients? Participants will received a virtual-reality-assisted rehabilitation on the second postoperative day for ten days. The rehabilitation would be carried out two times per day and 30 minutes per training.

Detailed Description
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Despite the increasing development of revascularisation techniques, lower limb amputation often represent the last chance of survival for the vasculopathic patient with chronic limb threatening ischemia (CLTI). First goal after lower limb amputation is represented by a rapid prosthesis application. The patient in the immediate post-operative period must undergo intensive rehabilitation and physiotherapy, which involves not only a physical but also a psychological approach. Classical recovery following lower limb amputation includes adequate pain therapy and physiotherapy to regain independence, strength, mobility and finally prothesis application to improve quality of life and restore mobility. The aim of this study is to investigate the effect of adding virtual reality to traditional rehabilitation following a lower limb amputation in patients due to limited circulation, with particularly attention to a possible improvement of psychological state, reduction of post-operative pain and more rapid improvement in regaining functional mobility

Official Title
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Investigation of the Influence of Virtual Reality on the Postoperative Period After Major Amputation.

Conditions
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Amputation, Lower Limb, Rehabilitation, Activities of Daily Living, Virtual Reality, Lower Extremity

Intervention / Treatment
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* Device: virtual reality rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years critical limb ischemia or acute limb ischemia amputation above/below knee unilateral lower limb amputees Exclusion Criteria: physical disability (paralysis, plegia) inability to give informed consent neurological or psychiatric problem that reduces compliance loss of planned post-operative assessments traumatic amputation in a patient without circulatory disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Patients after a major amputation would received at least 10 days of rehabilitation with the assistance of virtual reality. Before the operation, patients consent, life quality, pain score and motivation score were be evaluated. The rehabilitation with virtual reality started on the second postoperative day. The pain score would be evaluated everyday before and after the rehabilitation. On the fifth and tenth day, motivation, life quality and functional index would be carried out again as the evaluation of the outcome of training.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients receiving rehabilitation with virtual reality.<br>Single Group Assignment Patients after a major amputation would received at least 10 days of rehabilitation with the assistance of virtual reality. Before the operation, patients consent, life quality, pain score and motivation score were be evaluated. The rehabiliation with virtual reality started on the second postoperative day. The pain score would be evaluated everyday before and after the rebilitation. On the fifth and tenth day, motivation, life quality and functional index would be carried out again as the evaluation of the outcome of training. | Device: virtual reality rehabilitation<br>* All patients will receive VR-assisted rehabilitation. The VR-assisted rehabilitation is proceed with SyncVR® (Padualaan, Netherlands ) equipment, which is composed of a head set (PICO NEO 3) and one dashboard (TABLET), enabling the patients to receive stepwise rehabilitation program with 360° videos activities (SyncVR Medical Platform). The VR-assisted rehabilitation will be performed two times per day, 30 minutes per training. The first training will start on the second post-operative day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index | The change in activities of daily life among the patients before and after the implementation of the training program. | single time point (1 day) | 
| The Morton Mobility Index (DEMMI) | The change in mobility outcomes among the patients before and after the implementation of the training program. | single time point (1 day) | 
| Esslinger Transfer Scale | The change in the level of assistance needed for a safe transfer among the patients before and after the implementation of the training program. | single time point (1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12® Health Survey | The change in life quality in terms of both mentally and physically among the patients before and after the implementation of the training program. | single time point (1 day) | 
| 6-point Likert-scale | The change in pain among the patients before and after the implementation of the training program. | single time point (1 day) | 
| Situational Motivational Scale | The change in motivation among the patients before and after the implementation of the training program. | single time point (1 day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputation, Lower Extremity Ischemia, Lower Limb, Lower Limb Ischemia, Rehabilitation, Activities of Daily Living, Virtual Reality, Lower Limb Amputation Knee, Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee, Lower Extremity Wound