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

Not Applicable

Recruiting

• Conditions: Lower Limb; Lower Extremity; Rehabilitation; Virtual Reality; Amputation; Activities of Daily Living
• Interventions: Device: virtual reality rehabilitation

• Registration Number: NCT05773560
• Lead Sponsor: University Hospital Erlangen

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

Study Timeline

• Study Start: 2022-11-29
• Status Verified: 2023-03
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-17
• Last Update Posted: 2023-03-17
• Primary Completion: 2023-10
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients receiving rehabilitation with virtual reality.	virtual reality rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Barthel Index	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)	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	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 Outcome Measures

Name	Time	Method
SF-12® Health Survey	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.
6-point Likert-scale	single time point (1 day)	The change in pain among the patients before and after the implementation of the training program.
Situational Motivational Scale	single time point (1 day)	The change in motivation among the patients before and after the implementation of the training program.

Trial Locations

Locations (1)

University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery; 🇩🇪 Erlangen, Bavaria, Germany