Investigation of the Influence of Virtual Reality on the Postoperative Period After Major Amputation.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- University Hospital Erlangen
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Barthel Index
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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
Investigators
Ulrich Rother
PD Dr. med.
University Hospital Erlangen
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- SF-12® Health Survey(single time point (1 day))
- 6-point Likert-scale(single time point (1 day))
- Situational Motivational Scale(single time point (1 day))