In-home Versus Hospital Preoperative Training for Patients Undergoing Total Knee Replacement

NCT ID: NCT03100890

Last Updated: 2022-11-29

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

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-12

Study Completion Date

2019-11-01

Brief Summary

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In this work the importance of the potentiation and recovery of the balance with a physiotherapeutic intervention that begins in the early preoperative phase is compared with the conventional postoperative rehabilitation. The objective is to evaluate the influence of a muscle enhancement protocol in which a specific work of balance is included, with the physical benefits that this entails for the evolution of the patient. It also seeks to verify if the teaching and recommendation of exercises at home as preparation and conditioning for the intervention of ATR is effective, and to what extent, compared to a guided training in the hospital.

Detailed Description

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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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Control

Non-active comparator

Group Type NO_INTERVENTION

No interventions assigned to this group

Balance-Proprioception (Hospital)

Preoperative training (hospital)

Group Type ACTIVE_COMPARATOR

Preoperative training (hospital)

Intervention Type OTHER

Preoperative hospital training

Balance-Proprioception (Home)

Preoperative training (home)

Group Type EXPERIMENTAL

Preoperative training (home)

Intervention Type OTHER

Preoperative in-home training

Interventions

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Preoperative training (hospital)

Preoperative hospital training

Intervention Type OTHER

Preoperative training (home)

Preoperative in-home training

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects with severe knee osteoarthritis that have not been operated before of total knee replacement.
* The score in Berg scale must be greater than 21.
* The score of the Mini-Mental State Examination must be equal or greater than 20.
* Once the informed consent is read and explained, patients must accept and agree to participate in the study.

Exclusion Criteria

* Post-surgical infection of the operated knee.
* Pathology of central origin (i.e. cerebellar) that could interfere with balance or strength
* Vestibular pathology that could interfere with balance
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Politècnic i Universitari la Fe de València

UNKNOWN

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Jose María Blasco Igual

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José M Blasco, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

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University of Valencia

Valencia, , Spain

Site Status

Countries

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Spain

References

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Blasco JM, Igual-Camacho C, Roig-Casasus S. In-home versus hospital preoperative balance and proprioceptive training in patients undergoing TKR; rationale, design, and method of a randomized controlled trial. BMC Musculoskelet Disord. 2017 Dec 8;18(1):518. doi: 10.1186/s12891-017-1887-4.

Reference Type DERIVED
PMID: 29221471 (View on PubMed)

Other Identifiers

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PRE_ATR_home

Identifier Type: -

Identifier Source: org_study_id

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