Interactive Virtual Telerehabilitation After Total Knee Arthroplasty

NCT ID: NCT01604174

Last Updated: 2012-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Interactive Virtual Telerehabilitation

Rehabilitation by IVT

Group Type EXPERIMENTAL

Interactive Virtual Telerehabilitation (IVT)

Intervention Type OTHER

Rehabilitation after arthroplasty of knee using IVT

Standard rehabilitation care

Standard care rehabilitation after total knee arthroplasty

Group Type ACTIVE_COMPARATOR

Standard care rehabilitation

Intervention Type OTHER

Standard care rehabilitation after total knee arthroplasty

Interventions

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Interactive Virtual Telerehabilitation (IVT)

Rehabilitation after arthroplasty of knee using IVT

Intervention Type OTHER

Standard care rehabilitation

Standard care rehabilitation after total knee arthroplasty

Intervention Type OTHER

Other Intervention Names

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Rehabilitation procedure (physical manipulation) plus IVT Rehabilitation procedure (physical manipulation)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose M Muniesa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Parc de Salut Mar

Ferran Escalada, Md, PhD

Role: STUDY_DIRECTOR

Parc de Salut Mar

Locations

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Hospital del Mar (PSMAR)

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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REHABITIC

Identifier Type: -

Identifier Source: org_study_id

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