Trial Outcomes & Findings for Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty (NCT NCT02413996)
NCT ID: NCT02413996
Last Updated: 2020-01-09
Results Overview
The VAS scale was measured in a range of 0-100 cm (0 no pain and 100 the worst pain)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
baseline and 10 days (value at day 10 minus value at baseline)
Results posted on
2020-01-09
Participant Flow
Participants were recruited at the Rehabilitation Department, IRCCS Orthopedic Institute Galeazzi, Milan, between September 2014 and November 2017.
Participant milestones
| Measure |
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)
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
41
|
|
Overall Study
COMPLETED
|
35
|
39
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
| Measure |
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)
|
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
|
|---|---|---|
|
Overall Study
not comfortable with the intervention
|
9
|
2
|
Baseline Characteristics
Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
VRRS Rehabilitation
n=44 Participants
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)
|
Traditional Rehabilitation
n=41 Participants
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
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
69 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Right Total Knee Arthroplasty - no. (%)
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 10 days (value at day 10 minus value at baseline)Population: Available case analysis (drop-out \<20%)
The VAS scale was measured in a range of 0-100 cm (0 no pain and 100 the worst pain)
Outcome measures
| Measure |
VRRS Rehabilitation
n=35 Participants
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)
|
Traditional Rehabilitation
n=39 Participants
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
|
|---|---|---|
|
Pain: Visual Analogue Scale (VAS)
|
-23.03 units on a scale
Standard Deviation 21.06
|
-28.97 units on a scale
Standard Deviation 24.21
|
SECONDARY outcome
Timeframe: baseline and 10 days (value at day 10 minus value at baseline)Population: Available case analysis
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
Outcome measures
| Measure |
VRRS Rehabilitation
n=35 Participants
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)
|
Traditional Rehabilitation
n=39 Participants
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
|
|---|---|---|
|
Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire
|
790.28 units on a scale
Standard Deviation 234.36
|
767.6 units on a scale
Standard Deviation 197.10
|
SECONDARY outcome
Timeframe: assesed and reported at 10 daysPopulation: Available case analysis
assessed by Virtual Reality Rehabilitation System (degree of movement)
Outcome measures
| Measure |
VRRS Rehabilitation
n=34 Participants
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)
|
Traditional Rehabilitation
n=38 Participants
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
|
|---|---|---|
|
Knee Active Range of Motion
|
68.03 degree
Standard Deviation 13.56
|
69.75 degree
Standard Deviation 12.86
|
SECONDARY outcome
Timeframe: assessed and reported at 10 daysPopulation: Available case analysis
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).
Outcome measures
| Measure |
VRRS Rehabilitation
n=35 Participants
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)
|
Traditional Rehabilitation
n=39 Participants
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
|
|---|---|---|
|
Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)
|
0.13 units on a scale
Standard Deviation 0.11
|
0.15 units on a scale
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: assessed and reported at 10 daysPopulation: Available case analysis
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).
Outcome measures
| Measure |
VRRS Rehabilitation
n=34 Participants
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)
|
Traditional Rehabilitation
n=38 Participants
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
|
|---|---|---|
|
Global Perceived Effect (GPE)
|
4.58 score on a scale
Standard Deviation 0.49
|
4.71 score on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: baseline and 10 days (value at day 10 minus value at baseline)Population: Available case analysis
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).
Outcome measures
| Measure |
VRRS Rehabilitation
n=35 Participants
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)
|
Traditional Rehabilitation
n=39 Participants
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
|
|---|---|---|
|
The Functional Independence Measure (FIM) Scale
|
16.54 units on a scale
Standard Deviation 9.23
|
20.10 units on a scale
Standard Deviation 10.59
|
SECONDARY outcome
Timeframe: assessed and reported at 10 dayPopulation: Available case analysis
assessed by Virtual Reality Rehabilitation System (percentage value of similarity between ideal and patient knee movement trajector)
Outcome measures
| Measure |
VRRS Rehabilitation
n=33 Participants
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)
|
Traditional Rehabilitation
n=38 Participants
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
|
|---|---|---|
|
Proprioception
|
73.46 mm
Standard Deviation 14.97
|
59.86 mm
Standard Deviation 19.85
|
SECONDARY outcome
Timeframe: baseline and 10 days (value at day 10 minus value at baseline)Population: Available case analysis
Isometric strength of quadriceps and hamstrings is assessed by dynamometer (newton unit)
Outcome measures
| Measure |
VRRS Rehabilitation
n=28 Participants
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)
|
Traditional Rehabilitation
n=30 Participants
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
|
|---|---|---|
|
Isometric Strength of Quadriceps and Hamstrings
|
25.08 newton
Standard Deviation 32.29
|
25.50 newton
Standard Deviation 28.98
|
SECONDARY outcome
Timeframe: value at day 10Population: descriptive
number of drugs assumpted for each group during rehabilitation recovery
Outcome measures
| Measure |
VRRS Rehabilitation
n=35 Participants
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)
|
Traditional Rehabilitation
n=39 Participants
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
|
|---|---|---|
|
Drugs Assumption
|
50 number of drugs assumpted per group
|
53 number of drugs assumpted per group
|
Adverse Events
VRRS Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Traditional Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Davide Tornese
IRCCS Istituto Ortopedico Galeazzi, Milano
Phone: 0266214046
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place