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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773560
• Other study ID #: VR-amputation
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: January 2024

Study information

• Verified date: March 2023
• Source: University Hospital Erlangen
• Contact: Ulrich Rother, PD Dr. med.
• Phone: +4991318542028
• Email: ulrich.rother[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Activities of Daily Living
• Amputation
• Lower Extremity
• Lower Limb
• Rehabilitation
• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
Germany	University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Erlangen

Country where clinical trial is conducted

Germany, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barthel Index	The change in activities of daily life among the patients before and after the implementation of the training program.	single time point (1 day)
Primary	The Morton Mobility Index (DEMMI)	The change in mobility outcomes among the patients before and after the implementation of the training program.	single time point (1 day)
Primary	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.	single time point (1 day)
Secondary	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.	single time point (1 day)
Secondary	6-point Likert-scale	The change in pain among the patients before and after the implementation of the training program.	single time point (1 day)
Secondary	Situational Motivational Scale	The change in motivation among the patients before and after the implementation of the training program.	single time point (1 day)