Effectiveness of Immersive Virtual Reality in Functional Rehabilitation in Older People With Knee Arthroplasty

NCT04396782 | Unknown DMC

• 1 other identifier: UMALAGARV Knee
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Changes in six meter walking test (6-MWT) score

  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

  Baseline, up to three an six months.

Secondary Outcomes (6)

• Sit to Stand Test

  Baseline, up to three an six months.

• The range of motion

  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 McMaster Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline, up to three an six months.

Study Arms (2)

physiotherapy rehabilitation with IVR

EXPERIMENTAL

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.

Other: standard physiotherapy rehabilitation

standard physiotherapy rehabilitation

ACTIVE COMPARATOR

static bicycle, analytical lower limb exercises, global lower limb exercises and activities to be done at home.

Other: Physioterapy rehabilitation with IVR

Interventions

Physioterapy rehabilitation with IVR OTHER

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.

standard physiotherapy rehabilitation

standard physiotherapy rehabilitation OTHER

static bicycle, analytical lower limb exercises, global lower limb exercises and activities to be done at home. This group will perform only five minutes of virtual reality play, but will not use their lower limbs. This way, the results of rehabilitation will not be affected and therapists and patients will be blinded.

physiotherapy rehabilitation with IVR

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead
• Carmen Ruiz Vergara: collaborator
• Rocío Martín Valero: collaborator

Study Sites (1)

University of Málaga

Málaga, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 21, 2020
• Study Start: January 15, 2021
• Primary Completion: July 15, 2021
• Study Completion: September 30, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)