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OpenTrials
Completed

NCT Number: NCT01604174

Interactive Virtual Telerehabilitation After Total Knee Arthroplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar (PSMAR)

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interactive Virtual Telerehabilitation (IVT)

Other

Rehabilitation after arthroplasty of knee using IVT

Other names: Rehabilitation procedure (physical manipulation) plus IVT

standard care rehabilitation

Other

Standard care rehabilitation after total knee arthroplasty

Other names: Rehabilitation procedure (physical manipulation)

Primary outcomes

  1. Active knee extension/flexion

    Time frame: Change from baseline to 2 weeks

    Active knee extension/flexion measured by investigator

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Acronym: REHABITIC

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
May 23, 2012
Registry last updated
May 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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