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

NCT ID: NCT04396782

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

standard physiotherapy rehabilitation

Intervention Type: 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.

standard physiotherapy rehabilitation

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

Group Type: ACTIVE_COMPARATOR

Physioterapy rehabilitation with IVR

Intervention Type: 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.

Interventions

Physioterapy 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 Type: OTHER

standard physiotherapy rehabilitation

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmen Ruiz Vergara

UNKNOWN

Sponsor Role: collaborator

Rocío Martín Valero

UNKNOWN

Sponsor Role: collaborator

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Rocío Martín Valero

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Málaga

Málaga, , Spain

Countries

Spain

Other Identifiers

UMALAGARV Knee

Identifier Type: -

Identifier Source: org_study_id