Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

NCT ID: NCT02413996

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-05-25

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).

Detailed Description

Following ethics approval by the Ospedale San Raffaele, 84 adults aged between 45 and 80 years old will be recruited for the study, excluding people with unstable serious disease (e.g., heart or lung disease), previous orthopedics pathologies on the same side (e.g., hip arthroprosthesis), pregnancy and intake of psychotropic drugs.

Patients who consent to participate in this study will be randomized into two rehabilitation groups after TKA: experimental (virtual rehabilitation) and control (traditional rehabilitation). In the experimental arm, subjects will undergo a virtual rehabilitation training during the post-surgical rehabilitation period, in addition to passive knee range of motion device (kinetec) and functional activity (stairs). In the control arm, subjects with similar demographic characteristics to those of the experimental arm, will undergo the usual physiotherapy rehabilitation, in addition to passive knee range of motion device (kinetec) and functional activity (stairs). Both control and study interventions will be provided 60 minute daily session.

General status of patients will be undertaken for the following outcomes at the baseline and 10 days after surgery (at discharge).

The primary outcome will be the visual analogue scale (VAS); the secondary outcomes will be: the disability knee assessed by the Western Ontario and McMaster Universities (WOMAC), the health related quality of life assessed by the EuroQol (EQ-5D), the global perceived effect assessed by the GPE score, the functional Independent measure assessed by the FIM questionnaire, the drugs assumption, the isometric strength of quadriceps and hamstrings assessed by dynamometer, the range of motion (R.O.M.) and proprioception assessed by VRRS.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VRRS rehabilitation

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)

Group Type: EXPERIMENTAL

Kinetec® knee continuous passive motion (CPM )

Intervention Type: DEVICE

CPM of the knee

Functional activities

Intervention Type: BEHAVIORAL

Stairs, walking

VRRS rehabilitation

Intervention Type: OTHER

exercise therapy through a virtual reality rehabilitation system (VRRS)

traditional rehabilitation

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)

Group Type: ACTIVE_COMPARATOR

Kinetec® knee continuous passive motion (CPM )

Intervention Type: DEVICE

CPM of the knee

Functional activities

Intervention Type: BEHAVIORAL

Stairs, walking

traditional rehabilitation

Intervention Type: OTHER

exercise therapy through a traditional rehabilitation training made by physiotherapists

Interventions

Kinetec® knee continuous passive motion (CPM )

CPM of the knee

Intervention Type: DEVICE

Functional activities

Stairs, walking

Intervention Type: BEHAVIORAL

VRRS rehabilitation

exercise therapy through a virtual reality rehabilitation system (VRRS)

Intervention Type: OTHER

traditional rehabilitation

exercise therapy through a traditional rehabilitation training made by physiotherapists

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• primary unilateral TKA for knee osteoarthritis
• informed consent

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role: lead

Responsible Party

Davide Tornese

Medico Chirurgo Specialista in Medicina Fisica e Riabilitazione, Specialista in Medicina dello Sport, Responsabile reparto di Riabilitazione Sportiva

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe Banfi, MD

Role: STUDY_DIRECTOR

IRCCS Galeazzi Hospital

Locations

IRCCS Galeazzi Orthopedic Hospital

Milan, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32049833 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VRRS

Identifier Type: -

Identifier Source: org_study_id