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

NCT05773560 | Unknown

• 1 other identifier: VR-amputation
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• 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)

Study Arms (1)

Patients receiving rehabilitation with virtual reality.

EXPERIMENTAL

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

Interventions

virtual reality rehabilitation DEVICE

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.

Patients receiving rehabilitation with virtual reality.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years
• critical limb ischemia or acute limb ischemia
• amputation above/below knee
• unilateral lower limb amputees

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Erlangen: lead

Study Sites (1)

University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery

Erlangen, Bavaria, 91054, Germany

RECRUITING

Related Publications (10)

• 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.

  PMID: 17140820 BACKGROUND

• 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.

  PMID: 15497912 BACKGROUND

• 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.

  PMID: 17979011 BACKGROUND

• 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.

  PMID: 22289250 BACKGROUND

• 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.

  PMID: 16640472 BACKGROUND

• 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.

  PMID: 30681034 BACKGROUND

• 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.

  PMID: 33594443 BACKGROUND

• 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.

  PMID: 29525292 BACKGROUND

• 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.

  PMID: 33178449 BACKGROUND

• 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.

  PMID: 18713451 BACKGROUND

Central Study Contacts

Ulrich Rother, PD Dr. med.

CONTACT

+4991318542028; ulrich.rother@uk-erlangen.de

Werner Lang, Prof. Dr. med.

CONTACT

+4991318532968; werner.lang@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The researcher analyzing the final outcomes is blinded from the personal information and execution of the rehabilitation of the patients.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: November 29, 2022
• Primary Completion: October 1, 2023
• Study Completion: January 1, 2024
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)