N/A
N=85
Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty
Total Knee Replacement · Virtual Reality Therapy · Osteoarthritis · Knee Arthroplasty · Rehabilitation
Bottom Line
View on ClinicalTrials.gov: NCT02413996 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Pain: Visual Analogue Scale (VAS) — -23.03; -28.97 units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Kinetec® knee continuous passive motion (CPM ) (Device); Functional activities (Behavioral); VRRS rehabilitation (Other); traditional rehabilitation (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain: Visual Analogue Scale (VAS) |
-23.03; -28.97 | 0.05 |
| SECONDARY Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire |
790.28; 767.6 | — |
| SECONDARY Knee Active Range of Motion |
68.03; 69.75 | — |
| SECONDARY Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D) |
0.13; 0.15 | — |
| SECONDARY Global Perceived Effect (GPE) |
4.58; 4.71 | — |
| SECONDARY The Functional Independence Measure (FIM) Scale |
16.54; 20.10 | — |
| SECONDARY Proprioception |
73.46; 59.86 | — |
| SECONDARY Isometric Strength of Quadriceps and Hamstrings |
25.08; 25.50 | — |
| SECONDARY Drugs Assumption |
50; 53 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT02413996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.