NCT03100890

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

April 12, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

1.5 years

First QC Date

March 29, 2017

Last Update Submit

November 28, 2022

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    Self-reported functionality assessment

    change from baseline to the week before surgery, 2 and 6 weeks after surgery

  • Berg Balance Scale (BBS)

    Overall state of balance. Balance among older people with impairment in balance function by assessing the performance of functional tasks from the total score achieved in the 14 items test

    change from baseline to the week before surgery, 2 and 6 weeks after surgery

Secondary Outcomes (4)

  • Timed Up and Go Test (TUG)

    change from baseline to the week before surgery, 2 and 6 weeks after surgery

  • Knee Range of Mobility (ROM)

    change from baseline to the week before surgery, 2 and 6 weeks after surgery

  • Quadriceps Strength

    change from baseline to the week before surgery, 2 and 6 weeks after surgery

  • Euro Quality of Life 5 Dimension

    change from baseline to the week before surgery, 2 and 6 weeks after surgery

Study Arms (3)

Control

NO INTERVENTION

Non-active comparator

Balance-Proprioception (Hospital)

ACTIVE COMPARATOR

Preoperative training (hospital)

Other: Preoperative training (hospital)

Balance-Proprioception (Home)

EXPERIMENTAL

Preoperative training (home)

Other: Preoperative training (home)

Interventions

Preoperative training (hospital)OTHER

Preoperative hospital training

Balance-Proprioception (Hospital)
Preoperative training (home)OTHER

Preoperative in-home training

Balance-Proprioception (Home)

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29221471DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

HospitalsHome Care Services

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and ServicesCommunity Health ServicesHealth ServicesNursing Services

Study Officials

  • José M Blasco, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 4, 2017

Study Start

April 12, 2017

Primary Completion

October 1, 2018

Study Completion

November 1, 2019

Last Updated

November 29, 2022

Record last verified: 2022-11

Locations

ES(1)