Interactive Virtual Telerehabilitation After Total Knee Arthroplasty (REHABITIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01604174
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : May 24, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Interactive Virtual Telerehabilitation (IVT) Other: Standard care rehabilitation Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of an Interactive Virtual Telerehabilitation System in Patients After Total Knee Arthroplasty. A Randomized Controlled Trial
Study Start Date : November 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Interactive Virtual Telerehabilitation
Rehabilitation by IVT
Other: Interactive Virtual Telerehabilitation (IVT)
Rehabilitation after arthroplasty of knee using IVT
Other Name: Rehabilitation procedure (physical manipulation) plus IVT
Active Comparator: Standard rehabilitation care
Standard care rehabilitation after total knee arthroplasty
Other: Standard care rehabilitation
Standard care rehabilitation after total knee arthroplasty
Other Name: Rehabilitation procedure (physical manipulation)

Primary Outcome Measures :
  1. Active knee extension/flexion [ Time Frame: Change from baseline to 2 weeks ]
    Active knee extension/flexion measured by investigator

Secondary Outcome Measures :
  1. Muscle strength [ Time Frame: 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

  2. Pain [ Time Frame: Baseline to 2 weeks ]
    Measure of pain by visual analog scales

  3. Functional capacity [ Time Frame: Baseline to 2 weeks ]
    Measure of functional capacity using questionnaires /Western Ontario and MacMaster University)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01604174

Hospital del Mar (PSMAR)
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Principal Investigator: Jose M Muniesa, MD, PhD Parc de Salut Mar
Study Director: Ferran Escalada, Md, PhD Parc de Salut Mar

Responsible Party: Parc de Salut Mar Identifier: NCT01604174     History of Changes
Other Study ID Numbers: REHABITIC
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: May 24, 2012
Last Verified: May 2012

Keywords provided by Parc de Salut Mar:

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases