An interventional study of virtual reality rehabilitation in Amputation, Lower Limb and Rehabilitation, sponsored by University Hospital Erlangen. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-17.
Sponsored by University Hospital Erlangen · Not applicable, Interventional, and Supportive care
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:
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
University Hospital Erlangen is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Barthel Index
The change in activities of daily life among the patients before and after the implementation of the training program.
Time frame: 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.
Time frame: 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.
Time frame: single time point (1 day)
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.
Time frame: 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.
Time frame: single time point (1 day)
Situational Motivational Scale
The change in motivation among the patients before and after the implementation of the training program.
Time frame: single time point (1 day)
Plan to share: No
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University Hospital Erlangen