Interactive Virtual Telerehabilitation After Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Interactive Virtual Telerehabilitation (IVT); Other: Standard care rehabilitation

• Registration Number: NCT01604174
• Lead Sponsor: Parc de Salut Mar

Brief Summary

The purpose of this clinical trial is to compare the effectiveness of a new interactive virtual telerehabilitation (IVT) system with the conventional program in the rehabilitation of patients after total knee arthroplasty.

Detailed Description

Patients are distributed into two treatment groups: 1) Group I (control): standard clinical protocol of TKA rehabilitation consisting of 1-hour sessions for 10 days; and 2) Group II (IVT): 1-hour IVT sessions for 10 days (5 sessions under a therapist's supervision to verify the absence of medical complications + 5 sessions performed at home). The IVT is an interactive virtual software-hardware platform that facilitates the development of remote rehabilitation therapy for multiple diseases. Patients receive information required to perform exercise and the therapist remotely monitors the patient's performance. For the purpose of this trial, the IVT system was designed for lower limb motor recovery in patients undergoing TKA.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-11
• Study Completion: 2010-12
• Status Verified: 2012-05
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Last Update Submitted: 2012-05-23
• Last Update Posted: 2012-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Post-TKA active range of motion: flexion 80º and extension -10º
• ABsence of stiffness
• Ability to walk with the use of a walking aid
• Ability to read and understand Spanish
• Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation

Exclusion Criteria

• Sensory, cognitive and/or praxic impairment
• Concomitant medical conditions that may influence the rehabilitation process
• Discharge destination other than home
• Patients with any local or systemic complication (e.g., surgical wound infection, suspicion of deep vein thrombosis...) in the three-month follow-up period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interactive Virtual Telerehabilitation	Interactive Virtual Telerehabilitation (IVT)	Rehabilitation by IVT
Standard rehabilitation care	Standard care rehabilitation	Standard care rehabilitation after total knee arthroplasty

Primary Outcome Measures

Name	Time	Method
Active knee extension/flexion	Change from baseline to 2 weeks	Active knee extension/flexion measured by investigator

Secondary Outcome Measures

Name	Time	Method
Muscle strength	Baseline to 2 weeks	Measure of muscle stregth by investigator. That include measures of strength of the quadriceps, Harmstring muscle strength and Timed Getr-UP-ang-Go test
Pain	Baseline to 2 weeks	Measure of pain by visual analog scales
Functional capacity	Baseline to 2 weeks	Measure of functional capacity using questionnaires /Western Ontario and MacMaster University)

Trial Locations

Locations (1)

Hospital del Mar (PSMAR); 🇪🇸 Barcelona, Spain