Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02413996

Enrollment

Registered

2015-04-10

Start date

2014-09-30

Completion date

2018-05-25

Last updated

2020-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DEVICEKinetec® knee continuous passive motion (CPM )

CPM of the knee

BEHAVIORALFunctional activities

Stairs, walking

OTHERVRRS rehabilitation

exercise therapy through a virtual reality rehabilitation system (VRRS)

OTHERtraditional rehabilitation

exercise therapy through a traditional rehabilitation training made by physiotherapists

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain: Visual Analogue Scale (VAS)	baseline and 10 days (value at day 10 minus value at baseline)	The VAS scale was measured in a range of 0-100 cm (0 no pain and 100 the worst pain)

Secondary

Measure	Time frame	Description
Knee Active Range of Motion	assesed and reported at 10 days	assessed by Virtual Reality Rehabilitation System (degree of movement)
Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)	assessed and reported at 10 days	The EQ-5D comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.The EQ-5D descriptive system is divided into five levels of perceived problems: LEVEL 1: indicating no problem; LEVEL 2:indicating some problems;LEVEL 3: indicating extreme problems. EQ-5D health states can be summarised using the 5-digit code (e.g., 11111, 12311).The answers given to ED-5D permit to find 243 5-digit codes defining the health states.The 5-digit code are linked to an unique index derived by applying a formula that attaches values (weights) to each of the levels in each dimension.Weights depend on the country (Italian Population-Based Values of EQ-5D HealthStates,Scalone 2013).The index has been calculated by deducting the appropriate weights from 1 which is the best health status as highest score (i.e. the corresponding 5-digit code is 11111) and -0.38 for the worst health status as minimum score (i.e., the corresponding 5-digit code is 33333).
Global Perceived Effect (GPE)	assessed and reported at 10 days	The GPE scale asks the patient to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point. The GPE was administered at the end of the physiotherapy treatment to measure the effect of the intervention on patients' health status perception. This Likert scale had five response options (5 = Very much improved; 4 = Much improved, 3 = No change, 2 = Much worse, 1 = Very much worse).
Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire	baseline and 10 days (value at day 10 minus value at baseline)	The WOMAC measures five items for pain (score range 0-500), two for stiffness (score range 0-200), and 17 for functional limitation (score range 0-1700) for a total score of 2400 (0= no disability, 2400= highest disability): * Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing * Stiffness (2 items): after first waking and later in the day * Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties
Proprioception	assessed and reported at 10 day	assessed by Virtual Reality Rehabilitation System (percentage value of similarity between ideal and patient knee movement trajector)
Isometric Strength of Quadriceps and Hamstrings	baseline and 10 days (value at day 10 minus value at baseline)	Isometric strength of quadriceps and hamstrings is assessed by dynamometer (newton unit)
Drugs Assumption	value at day 10	number of drugs assumpted for each group during rehabilitation recovery
The Functional Independence Measure (FIM) Scale	baseline and 10 days (value at day 10 minus value at baseline)	The FIM scale assesses physical and cognitive disability focusing on the level of disability indicating the burden of caring for them. The total score is 126 (18=highest disability, 126=no disability).

Countries

Italy

Participant flow

Recruitment details

Participants were recruited at the Rehabilitation Department, IRCCS Orthopedic Institute Galeazzi, Milan, between September 2014 and November 2017.

Participants by arm

Arm	Count
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) Kinetec® knee continuous passive motion (CPM ): CPM of the knee Functional activities: Stairs, walking VRRS rehabilitation: exercise therapy through a virtual reality rehabilitation system (VRRS)	44
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) Kinetec® knee continuous passive motion (CPM ): CPM of the knee Functional activities: Stairs, walking traditional rehabilitation: exercise therapy through a traditional rehabilitation training made by physiotherapists	41
Total	85

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	not comfortable with the intervention	9	2

Baseline characteristics

Characteristic	VRRS Rehabilitation	Total	Traditional Rehabilitation
Age, Continuous	66.6 years STANDARD_DEVIATION 8.7	69 years STANDARD_DEVIATION 8.9	70.7 years STANDARD_DEVIATION 8.5
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	44 Participants	85 Participants	41 Participants
Right Total Knee Arthroplasty - no. (%)	20 Participants	38 Participants	18 Participants
Sex: Female, Male Female	20 Participants	48 Participants	28 Participants
Sex: Female, Male Male	24 Participants	37 Participants	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 44	0 / 41
other Total, other adverse events	0 / 44	0 / 41
serious Total, serious adverse events	0 / 44	0 / 41

Outcome results

Primary

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)

Time frame: baseline and 10 days (value at day 10 minus value at baseline)

Population: Available case analysis (drop-out \<20%)

Arm	Measure	Value (MEAN)	Dispersion
VRRS Rehabilitation	Pain: Visual Analogue Scale (VAS)	-23.03 units on a scale	Standard Deviation 21.06
Traditional Rehabilitation	Pain: Visual Analogue Scale (VAS)	-28.97 units on a scale	Standard Deviation 24.21

Comparison: Does VRRS rehabilitation is superior to the traditional one?p-value: 0.0595% CI: [-4.62, 16.51]t-test, 2 sided

Secondary

Drugs Assumption

number of drugs assumpted for each group during rehabilitation recovery

Time frame: value at day 10

Population: descriptive

Arm	Measure	Value (NUMBER)
VRRS Rehabilitation	Drugs Assumption	50 number of drugs assumpted per group
Traditional Rehabilitation	Drugs Assumption	53 number of drugs assumpted per group

Secondary

Global Perceived Effect (GPE)

The GPE scale asks the patient to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point. The GPE was administered at the end of the physiotherapy treatment to measure the effect of the intervention on patients' health status perception. This Likert scale had five response options (5 = Very much improved; 4 = Much improved, 3 = No change, 2 = Much worse, 1 = Very much worse).

Time frame: assessed and reported at 10 days