Effectiveness of Immersive Virtual Reality in Functional Rehabilitation in Older People With Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Malaga
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Changes in six meter walking test (6-MWT) score
Study Overview
Brief Summary
The number of knee arthroplasties performed each year is constantly increasing. Although the outcome is generally favourable, 10-20% do not achieve a satisfactory clinical result. This study evaluates the effectiveness of immersive virtual reality rehabilitation in older people who have undergone knee arthroplasty surgery. The 6 Meter Walking Test is used to determine the improvement of patients after the procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •people who are admitted to one of the two chosen residences on the Costa del Sol who have had, or will have, a total knee arthroplasty recently.
- •People between 60-75, who want to receive rehabilitation treatment.
Exclusion Criteria
- •Patients who refuse to participate or who suffer serious post-operative complications.
- •patients with neurological or cognitive impairment that could interfere with the performance of the rehabilitative treatment will be excluded.
- •Those with any severe cardiovascular or pulmonary disease that would prevent them from exercising and also those who are not allowed physical activity for any reason.
- •Those with poor visual acuity who are unable to see the visual characteristics of the screen.
- •Patients with severe contralateral knee osteoarthritis (>5/10 pain when climbing stairs) or other orthopaedic conditions that limited function and required an alternative simultaneous operation, e.g. severe lumbar spinal stenosis, severe OA of the hip or ankle...
- •Those who are scheduled for other lower limb surgery in the next 6 months.
Arms & Interventions
physiotherapy rehabilitation with IVR
This program includes: static bicycle with virtual reality glasses, analytical lower limb exercises, global lower limb exerciseswith virtual reality glasses and activities to be done at home.
Intervention: standard physiotherapy rehabilitation (Other)
standard physiotherapy rehabilitation
static bicycle, analytical lower limb exercises, global lower limb exercises and activities to be done at home.
Intervention: Physioterapy rehabilitation with IVR (Other)
Outcomes
Primary Outcomes
Changes in six meter walking test (6-MWT) score
Time Frame: Baseline, up to three an six months.
Six-meter walking test is a a well-established outcome measure in a variety of diseases. It is accurate, reproducible, simple to administer, and well tolerated. The 6MWT is a robust assessment tool for use in clinical trials given its ability to quantitatively evaluate ambulation in a controlled environment. Participants will be asked to do quick laps in a flat corridor for 6 minutes with the verbal stimulus provided by the assessor at the end of each lap. A significant improvement threshold after surgery could be between 26 and 55m
Secondary Outcomes
- The range of motion(Baseline, up to three an six months.)
- The McMaster Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)(Baseline, up to three an six months.)
- Sit to Stand Test(Baseline, up to three an six months.)
- The Oxford Knee Score (OKS)(Baseline, up to three an six months.)
- The BERG scale(Baseline, up to three an six months.)
- The User Satisfaction Evaluation Questionnaire(up to six months)
Investigators
Rocío Martín Valero
PhD
University of Malaga