Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

• Sponsor: Istituto Ortopedico Galeazzi (Other)
• Overall Status: Completed
• CT.gov ID: NCT02413996
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Arms: 2
• Duration (Months): 44.7
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Total Knee Replacement; Virtual Reality Therapy; Osteoarthritis; Knee Arthroplasty; Rehabilitation	Device: Kinetec® knee continuous passive motion (CPM ); Behavioral: Functional activities; Other: VRRS rehabilitation; Other: traditional rehabilitation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A phase III randomized clinical trial was approved by the San Raffaele Hospital's Ethic Committee of Milan (31/03/2014)A phase III randomized clinical trial was approved by the San Raffaele Hospital's Ethic Committee of Milan (31/03/2014)
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: May 5, 2018
• Actual Study Completion Date: May 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Device: Kinetec® knee continuous passive motion (CPM ); CPM of the knee; Behavioral: Functional activities; Stairs, walking; Other: VRRS rehabilitation; exercise therapy through a virtual reality rehabilitation system (VRRS)
Active Comparator: 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)	Device: Kinetec® knee continuous passive motion (CPM ); CPM of the knee; Behavioral: Functional activities; Stairs, walking; Other: traditional rehabilitation; exercise therapy through a traditional rehabilitation training made by physiotherapists

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. Knee Active Range of Motion [assesed and reported at 10 days]

   assessed by Virtual Reality Rehabilitation System (degree of movement)

3. 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).

4. 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).

5. 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).

6. Proprioception [assessed and reported at 10 day]

   assessed by Virtual Reality Rehabilitation System (percentage value of similarity between ideal and patient knee movement trajector)

7. 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)

8. Drugs Assumption [value at day 10]

   number of drugs assumpted for each group during rehabilitation recovery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Galeazzi Orthopedic Hospital	Milan		Italy	20161

Sponsors and Collaborators

• Istituto Ortopedico Galeazzi

Investigators

• Study Director: Giuseppe Banfi, MD, IRCCS Galeazzi Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 6, 2014

More Information

Publications

None provided.

• Responsible Party: Davide Tornese, Medico Chirurgo Specialista in Medicina Fisica e Riabilitazione, Specialista in Medicina dello Sport, Responsabile reparto di Riabilitazione Sportiva, Istituto Ortopedico Galeazzi
• ClinicalTrials.gov Identifier: NCT02413996
• Other Study ID Numbers: VRRS
• First Posted: Apr 10, 2015
• Last Update Posted: Jan 9, 2020
• Last Verified: Dec 1, 2019

• Keywords provided by Davide Tornese, Medico Chirurgo Specialista in Medicina Fisica e Riabilitazione, Specialista in Medicina dello Sport, Responsabile reparto di Riabilitazione Sportiva, Istituto Ortopedico Galeazzi: Virtual Reality Therapy; Rehabilitation; Total Knee Replacement; Knee Arthroplasty; Exercise; Arthritis; Rheumatic Disease
• Additional relevant MeSH terms: Osteoarthritis

Study Results

Participant Flow

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

Arm/Group Title	VRRS Rehabilitation	Traditional Rehabilitation
Arm/Group Description	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)	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
Period Title: Overall Study
STARTED	44	41
COMPLETED	35	39
NOT COMPLETED	9	2

Baseline Characteristics

Arm/Group Title	VRRS Rehabilitation	Traditional Rehabilitation	Total
Arm/Group Description	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)	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	Total of all reporting groups
Overall Participants	44	41	85
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.6 (8.7)	70.7 (8.5)	69 (8.9)
Sex: Female, Male (Count of Participants)
Female	20 45.5%	28 68.3%	48 56.5%
Male	24 54.5%	13 31.7%	37 43.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	44 100%	41 100%	85 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Right Total Knee Arthroplasty - no. (%) (Count of Participants)
Count of Participants [Participants]	20 45.5%	18 43.9%	38 44.7%

Outcome Measures

1. Primary Outcome

Title	Pain: Visual Analogue Scale (VAS)
Description	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)

Outcome Measure Data

Analysis Population Description

Available case analysis (drop-out <20%)

Arm/Group Title	VRRS Rehabilitation	Traditional Rehabilitation
Arm/Group Description	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)	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
Measure Participants	35	39
Mean (Standard Deviation) [units on a scale]	-23.03 (21.06)	-28.97 (24.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	VRRS Rehabilitation, Traditional Rehabilitation
	Comments	Does VRRS rehabilitation is superior to the traditional one?
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	5.94
	Confidence Interval	(2-Sided) 95%; -4.62 to 16.51
	Parameter Dispersion	Type: Standard Deviation; Value: 5.30
	Estimation Comments

2. Secondary Outcome

Title	Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire
Description	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
Time Frame	baseline and 10 days (value at day 10 minus value at baseline)

Outcome Measure Data

Analysis Population Description

Available case analysis

Arm/Group Title	VRRS Rehabilitation	Traditional Rehabilitation
Arm/Group Description	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)	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
Measure Participants	35	39
Mean (Standard Deviation) [units on a scale]	790.28 (234.36)	767.6 (197.10)

3. Secondary Outcome

Title	Knee Active Range of Motion
Description	assessed by Virtual Reality Rehabilitation System (degree of movement)
Time Frame	assesed and reported at 10 days

Outcome Measure Data

Analysis Population Description

Available case analysis

Arm/Group Title	VRRS Rehabilitation	Traditional Rehabilitation
Arm/Group Description	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)	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
Measure Participants	34	38
Mean (Standard Deviation) [degree]	68.03 (13.56)	69.75 (12.86)

4. Secondary Outcome

Title	Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)
Description	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).
Time Frame	assessed and reported at 10 days

Outcome Measure Data

Analysis Population Description

Available case analysis

Arm/Group Title	VRRS Rehabilitation	Traditional Rehabilitation
Arm/Group Description	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)	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
Measure Participants	35	39
Mean (Standard Deviation) [units on a scale]	0.13 (0.11)	0.15 (0.19)

5. Secondary Outcome

Title	Global Perceived Effect (GPE)
Description	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

Outcome Measure Data

Analysis Population Description

Available case analysis

Arm/Group Title	VRRS Rehabilitation	Traditional Rehabilitation
Arm/Group Description	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)	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
Measure Participants	34	38
Mean (Standard Deviation) [score on a scale]	4.58 (0.49)	4.71 (0.45)

6. Secondary Outcome

Title	The Functional Independence Measure (FIM) Scale
Description	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).
Time Frame	baseline and 10 days (value at day 10 minus value at baseline)

Outcome Measure Data

Analysis Population Description

Available case analysis

Arm/Group Title	VRRS Rehabilitation	Traditional Rehabilitation
Arm/Group Description	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)	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
Measure Participants	35	39
Mean (Standard Deviation) [units on a scale]	16.54 (9.23)	20.10 (10.59)

7. Secondary Outcome

Title	Proprioception
Description	assessed by Virtual Reality Rehabilitation System (percentage value of similarity between ideal and patient knee movement trajector)
Time Frame	assessed and reported at 10 day

Outcome Measure Data

Analysis Population Description

Available case analysis

Arm/Group Title	VRRS Rehabilitation	Traditional Rehabilitation
Arm/Group Description	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)	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
Measure Participants	33	38
Mean (Standard Deviation) [mm]	73.46 (14.97)	59.86 (19.85)

8. Secondary Outcome

Title	Isometric Strength of Quadriceps and Hamstrings
Description	Isometric strength of quadriceps and hamstrings is assessed by dynamometer (newton unit)
Time Frame	baseline and 10 days (value at day 10 minus value at baseline)

Outcome Measure Data

Analysis Population Description

Available case analysis

Arm/Group Title	VRRS Rehabilitation	Traditional Rehabilitation
Arm/Group Description	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)	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
Measure Participants	28	30
Mean (Standard Deviation) [newton]	25.08 (32.29)	25.50 (28.98)

9. Secondary Outcome

Title	Drugs Assumption
Description	number of drugs assumpted for each group during rehabilitation recovery
Time Frame	value at day 10

Outcome Measure Data

Analysis Population Description

descriptive

Arm/Group Title	VRRS Rehabilitation	Traditional Rehabilitation
Arm/Group Description	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)	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
Measure Participants	35	39
Number [number of drugs assumpted per group]	50	53

Adverse Events

Time Frame	10 days after surgery
Adverse Event Reporting Description	Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Arm/Group Title	VRRS Rehabilitation		Traditional Rehabilitation
Arm/Group Description	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)		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
All Cause Mortality
	VRRS Rehabilitation		Traditional Rehabilitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/41 (0%)
Serious Adverse Events
	VRRS Rehabilitation		Traditional Rehabilitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	VRRS Rehabilitation		Traditional Rehabilitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/41 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.