Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

NCT02413996 | Completed Results DMC

• 1 other identifier: VRRS
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the efficacy of virtual rehabilitation through the Virtual Reality Rehabilitation System (VRRS) versus traditional rehabilitation improving the functional outcomes after primary Total Knee Arthroplasty (TKA).

Conditions

Total Knee Replacement; Virtual Reality Therapy; Osteoarthritis; Knee Arthroplasty; Rehabilitation

Keywords

Virtual Reality Therapy; Rehabilitation; Total Knee Replacement; Knee Arthroplasty; Exercise; Arthritis; Rheumatic Disease

Outcome Measures

Primary Outcomes (1)

• Pain: Visual Analogue Scale (VAS)

  The VAS scale was measured in a range of 0-100 cm (0 no pain and 100 the worst pain)

  baseline and 10 days (value at day 10 minus value at baseline)

Secondary Outcomes (8)

• Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire

  baseline and 10 days (value at day 10 minus value at baseline)

• Knee Active Range of Motion

  assesed and reported at 10 days

• Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)

  assessed and reported at 10 days

• Global Perceived Effect (GPE)

  assessed and reported at 10 days

• The Functional Independence Measure (FIM) Scale

  baseline and 10 days (value at day 10 minus value at baseline)

Study Arms (2)

VRRS rehabilitation

EXPERIMENTAL

exercise therapy through a virtual reality rehabilitation system (VRRS) in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking)

Device: Kinetec® knee continuous passive motion (CPM ); Behavioral: Functional activities; Other: VRRS rehabilitation

traditional rehabilitation

ACTIVE COMPARATOR

exercise therapy through a traditional rehabilitation training in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking)

Device: Kinetec® knee continuous passive motion (CPM ); Behavioral: Functional activities; Other: traditional rehabilitation

Interventions

Kinetec® knee continuous passive motion (CPM ) DEVICE

CPM of the knee

VRRS rehabilitation; traditional rehabilitation

Functional activities BEHAVIORAL

Stairs, walking

VRRS rehabilitation; traditional rehabilitation

VRRS rehabilitation OTHER

exercise therapy through a virtual reality rehabilitation system (VRRS)

VRRS rehabilitation

traditional rehabilitation OTHER

exercise therapy through a traditional rehabilitation training made by physiotherapists

traditional rehabilitation

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary unilateral TKA for knee osteoarthritis
• informed consent

You may not qualify if:

• people with unstable serious disease (e.g., heart or lung disease)
• people with previous orthopedics pathologies on the same side (e.g., hip arthroprosthesis)
• pregnancy
• psychotropic drugs assumption

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Galeazzi Orthopedic Hospital

Milan, 20161, Italy

Location

Related Publications (1)

• Gianola S, Stucovitz E, Castellini G, Mascali M, Vanni F, Tramacere I, Banfi G, Tornese D. Effects of early virtual reality-based rehabilitation in patients with total knee arthroplasty: A randomized controlled trial. Medicine (Baltimore). 2020 Feb;99(7):e19136. doi: 10.1097/MD.0000000000019136.

  PMID: 32049833 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Motor Activity; Arthritis; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Behavior; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Davide Tornese
• Organization: IRCCS Istituto Ortopedico Galeazzi, Milano

davidzai@tin.it

0266214046

Study Officials

• Giuseppe Banfi, MD

  IRCCS Galeazzi Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medico Chirurgo Specialista in Medicina Fisica e Riabilitazione, Specialista in Medicina dello Sport, Responsabile reparto di Riabilitazione Sportiva

Model Details: A phase III randomized clinical trial was approved by the San Raffaele Hospital's Ethic Committee of Milan (31/03/2014)

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: April 10, 2015
• Study Start: September 1, 2014
• Primary Completion: May 5, 2018
• Study Completion: May 25, 2018
• Last Updated: January 9, 2020
• Results First Posted: January 9, 2020

Record last verified: 2019-12

Locations

IT (1)