Clinical trial NCT05773560: Virtual Reality in the Rehabilitation in Patients With Lower Limb Amputation.
Official title: Investigation of the Influence of Virtual Reality on the Postoperative Period After Major Amputation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amputation
Lower Limb
Rehabilitation
Activities of Daily Living
Virtual Reality
Lower Extremity
Keywords: 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
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Barthel Index
timeFrame: single time point (1 day)
measure: The Morton Mobility Index (DEMMI)
timeFrame: single time point (1 day)
measure: Esslinger Transfer Scale
timeFrame: single time point (1 day)
Secondary outcomes:
measure: SF-12® Health Survey
timeFrame: single time point (1 day)
measure: 6-point Likert-scale
timeFrame: single time point (1 day)
measure: Situational Motivational Scale
timeFrame: single time point (1 day)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
state: Bavaria
Study officials:
References:
citation: Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
citation: Esquenazi A. Amputation rehabilitation and prosthetic restoration. From surgery to community reintegration. Disabil Rehabil. 2004 Jul 22-Aug 5;26(14-15):831-6. doi: 10.1080/09638280410001708850.
citation: Rau B, Bonvin F, de Bie R. Short-term effect of physiotherapy rehabilitation on functional performance of lower limb amputees. Prosthet Orthot Int. 2007 Sep;31(3):258-70. doi: 10.1080/03093640600994615.
citation: Andrysek J, Klejman S, Steinnagel B, Torres-Moreno R, Zabjek KF, Salbach NM, Moody K. Preliminary evaluation of a commercially available videogame system as an adjunct therapeutic intervention for improving balance among children and adolescents with lower limb amputations. Arch Phys Med Rehabil. 2012 Feb;93(2):358-66. doi: 10.1016/j.apmr.2011.08.031.
citation: Murray CD, Patchick E, Pettifer S, Caillette F, Howard T. Immersive virtual reality as a rehabilitative technology for phantom limb experience: a protocol. Cyberpsychol Behav. 2006 Apr;9(2):167-70. doi: 10.1089/cpb.2006.9.167.
citation: Rothgangel A, Bekrater-Bodmann R. Mirror therapy versus augmented/virtual reality applications: towards a tailored mechanism-based treatment for phantom limb pain. Pain Manag. 2019 Mar 1;9(2):151-159. doi: 10.2217/pmt-2018-0066. Epub 2019 Jan 25.
citation: de Rooij IJM, van de Port IGL, Punt M, Abbink-van Moorsel PJM, Kortsmit M, van Eijk RPA, Visser-Meily JMA, Meijer JG. Effect of Virtual Reality Gait Training on Participation in Survivors of Subacute Stroke: A Randomized Controlled Trial. Phys Ther. 2021 May 4;101(5):pzab051. doi: 10.1093/ptj/pzab051.
citation: Dominguez-Navarro F, Igual-Camacho C, Silvestre-Munoz A, Roig-Casasus S, Blasco JM. Effects of balance and proprioceptive training on total hip and knee replacement rehabilitation: A systematic review and meta-analysis. Gait Posture. 2018 May;62:68-74. doi: 10.1016/j.gaitpost.2018.03.003. Epub 2018 Mar 5.
citation: Smits M, Staal JB, van Goor H. Could Virtual Reality play a role in the rehabilitation after COVID-19 infection? BMJ Open Sport Exerc Med. 2020 Oct 23;6(1):e000943. doi: 10.1136/bmjsem-2020-000943. eCollection 2020.
citation: de Morton NA, Davidson M, Keating JL. The de Morton Mobility Index (DEMMI): an essential health index for an ageing world. Health Qual Life Outcomes. 2008 Aug 19;6:63. doi: 10.1186/1477-7525-6-63.