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Completed

NCT Number: NCT03454256

Virtual Reality Rehabilitation in Patients With Total Knee Replacement

Impaired proprioceptive accuracy could be a risk factor for progression of gait limitations in knee osteoarthritis patients, even after the Total Knee Replacement (TKR). Recent studies on Virtual Reality (VR) in rehabilitation show its efficacy in restoring proprioceptive capacity, postural control and gait. However, literature lacks such studies in TKR patients. This preliminary study aims to evaluate the efficacy of a VR system for the enhancement of motor skills in TKR patients compared to a traditional approach of rehabilitation.

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Key information

Conditions

Knee Arthropathy Total Knee Replacement

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele Pisana

Roma, RM, 00166, Italy

About this study

In this randomized controlled trial (RCT), the randomization of the sample will be performed by a local software and in a single blind design. Forty patients will be enrolled and after giving the informed consent, assigned to two groups :

  • the experimental group (VRG), which will be undergone to treatment with virtual reality for the recovery of load distribution and proper gait pattern;
  • the control group (CG), which will be undergone to a traditional rehabilitation addressed to recovery of correct gait pattern for the same time period as VRG.

Both treatments consist in 15 sessions, at least 5 per week , each lasting 45 minutes. Both VRG or CG will last for 21 days from the start of treatment.

All patients, in adjunction to Virtual Reality Rehabilitation (EG) or Traditional Rehabilitation (CG), will execute a global rehabilitation project, consisting in Physiotherapy, Physical Therapies for pain and inflammation control, and Occupational Therapy, personalized by a multidisciplinary rehabilitation team for a minimum of 150-180 minutes per day, and according to their clinical conditions for them.

The purposes of this study in detail are:

  • Observing differences in the distribution of the bi-podalic load in the group that performs a re-education with virtual reality compared to those who perform the traditional treatment.
  • Observing differences in the recovery time of a correct pattern of gait in the group that performs a re-education with virtual reality compared to those who perform a traditional treatment.
  • Observing changes in neurophysiological patterns in the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • recruitment and initial assessment within 10 days of surgery;
  • monolateral knee arthroplasty in election;
  • collaborating patients who are able to perform the proposed exercise;
  • good cardiovascular compensation;
  • cognitively intact;
  • able to provide informed consent;

Exclusion criteria

  • no severe cognitive / behavioral deficit;
  • refusal or inability to provide informed consent;
  • presence of sever cardiorespiratory co-morbidities;
  • peripheral and /or central neurological deficits;
  • visual deficits;
  • presence of serious osteo-arthro-muscular diseases at controlateral lower limb against the prosthetic side;
  • complication at surgical wound

Treatment and study plan

Virtual reality

Device

Virtual Reality Rehabilitation System

Other names: VRRS EVO, Khymeia s.r.l., Italy

Primary outcomes

  1. Change in Time Up and Go (TUG)

    Time frame: Session 1 (baseline) and session 15 (day 21)

    The TUG is a timed test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.

Secondary outcomes

  1. Change in 10 Meter Walk Test (10-MWT)

    Time frame: Session 1 (baseline) and session 15 (day 21)

    The 10-MWT examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 second). The test will be recorded 3 times, with adequate rest in between. The average of the 3 times should be recorded.

  2. Change in Medical Research Council scale (MRC)

    Time frame: Session 1 (baseline) and session 15 (day 21)

    The MRC will be used to evaluate the muscle strength of Quadriceps Femoris (QF) and Tibialis Anterior (TA). The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.

  3. Change in Visual Analog Scale (VAS)

    Time frame: Session 1 (baseline) and session 15 (day 21)

    VAS is a 0-10 rating scale for pain which is used to gain a subjective report of the intensity of a person's pain. Zero represents "no pain" and ten represents "the most intense pain imaginable". A meaningful change would be plus or minus 3 points.

  4. Change in Barthel Index (BI)

    Time frame: Session 1 (baseline) and session 15 (day 21)

    The BI is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.

  5. MiniMental State evaluation (MMSE)

    Time frame: Session 1 (baseline)

    The MMSE (Folstein et al., 1975), is a 30-point questionnaire that is used extensively in clinical and research settings to measure intellectual efficiency disorder as well as cognitive impairment.

Other outcomes

  1. Gait Analysis

    Time frame: Session 1 (baseline) and session 15 (day 21)

    Kinematic and kinetic gait parameters will be calculated from data acquired with a motion capture system (SMART-DX; BTSBioengneering, Italy).

  2. Postural Analysis

    Time frame: Session 1 (baseline) and session 15 (day 21)

    Posturographic parameters will be obtained from the analysis of the center of pressure (COP) trajectories measured by force platforms during standing in both open and closed eyes conditions.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Official study title

Effects of Virtual Reality Rehabilitation in Patients With Total Knee Replacement

Acronym: VRRS_KNEE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2018
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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