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

March 6, 2023 updated by: Ulrich Rother, University Hospital Erlangen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katia Dessi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients receiving rehabilitation with virtual reality.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index
Time Frame: single time point (1 day)
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)
Time Frame: single time point (1 day)
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
Time Frame: single time point (1 day)
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
Time Frame: single time point (1 day)
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
Time Frame: single time point (1 day)
The change in pain among the patients before and after the implementation of the training program.
single time point (1 day)
Situational Motivational Scale
Time Frame: single time point (1 day)
The change in motivation among the patients before and after the implementation of the training program.
single time point (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Erlangen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VR-amputation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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