Interactive Virtual Telerehabilitation After Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

— REHABITIC  

Official title:

Effectiveness of an Interactive Virtual Telerehabilitation System in Patients After Total Knee Arthroplasty. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604174
• Other study ID #: REHABITIC
• Status: Completed
• Phase: N/A
• First received: May 21, 2012
• Last updated: May 23, 2012
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: May 2012
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Interactive Virtual Telerehabilitation (IVT)
Rehabilitation after arthroplasty of knee using IVT
• Standard care rehabilitation
Standard care rehabilitation after total knee arthroplasty

Locations

Country	Name	City	State
Spain	Hospital del Mar (PSMAR)	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active knee extension/flexion	Active knee extension/flexion measured by investigator	Change from baseline to 2 weeks	No
Secondary	Muscle strength	Measure of muscle stregth by investigator. That include measures of strength of the quadriceps, Harmstring muscle strength and Timed Getr-UP-ang-Go test	Baseline to 2 weeks	No
Secondary	Pain	Measure of pain by visual analog scales	Baseline to 2 weeks	No
Secondary	Functional capacity	Measure of functional capacity using questionnaires /Western Ontario and MacMaster University)	Baseline to 2 weeks	No