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Interactive Virtual Telerehabilitation After Total Knee Arthroplasty (REHABITIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01604174
First received: May 21, 2012
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Knee Osteoarthritis
 Other: Interactive Virtual Telerehabilitation (IVT)
Other: Standard care rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Active knee extension/flexion [ Time Frame: Change from baseline to 2 weeks ] [ Designated as safety issue: No ]
    Active knee extension/flexion measured by investigator


Secondary Outcome Measures:
  • Muscle strength [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
    Measure of pain by visual analog scales

  • Functional capacity [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
    Measure of functional capacity using questionnaires /Western Ontario and MacMaster University)


Enrollment: 140
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604174

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

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01604174     History of Changes
Other Study ID Numbers: REHABITIC
Study First Received: May 21, 2012
Last Updated: May 23, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Parc de Salut Mar:
knee
osteoarthritis
arthroplasty
rehabilitation

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

ClinicalTrials.gov processed this record on May 23, 2013