Back to resultsInfluences of Balance Training With a Dynamometric Platform in Total Knee Arthroplasty (TKA_DP)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional Recovery
Balance Training
Dynamometric Platform Training
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring total knee replacement, total knee arthroplasty, rehabilitation, physical therapy, balance
Eligibility Criteria
Inclusion Criteria:
- Age between 65 and 85.
- Subjects with knee osteoarthritis that have not been operated before.
- Patients operated with the same total replacement prosthesis.
- Patients operated with the same surgical procedure.
- Time before intervention over 4 weeks.
- Time to start rehabilitation after surgery must be less than 4 weeks.
- The Result in Berg scale must be greater than 21, indicating a medium-low risk of falling.
- the Result of the Mini-Mental State Examination must be equal or greater than 20, which means they do not have moderate or severe cognitive impairment.
- Once the informed consent is read and explained, patients must accept and agree to participate in the study.
Exclusion Criteria:
- Patient does no accept sign the informed consent.
- Patient with morphological alterations hip or ankle (also knee).
- Patient that presents knee flexion out of the range between 70 ° and -20 ° because of the risk posed to suffer a fall.
- Patient with suspected deep vein thrombosis.
- Patient with post-surgical infection of the operated knee.
- Patient with psychiatric disorders: depression, anxious syndrome, etc.
- Patient with pathology of central origin (i.e. cerebellar) that could interfere with the results of the test of balance or strength
- Patient with vestibular pathology that could interfere with the results of the test of balance
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EXPERIMENTAL
CONTROL
Arm Description
Functional recovery Balance training
Functional recovery Balance training Dynamometric Platform training
Outcomes
Primary Outcome Measures
Berg Balance Scale
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
Secondary Outcome Measures
Functional Reach (cm)
Assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position
Timed Up and Go Test (s)
Dynamic balance assessment. Also points at the risk of falling. Time of getting up from a chair, walk three meters, come back and sit again, measured in seconds
Romberg Tests
Total score achieved with open and closed eyes and on firm surface
Knee Range of Mobility (º)
Knee Range of Mobility (Flexion, Extension) in degrees
Kendall and Lovet scale
Muscle Balance estimated with with Kendall and Lovet scale (score from 0 to 5)
Full Information
NCT ID
NCT02734225
First Posted
March 2, 2016
Last Updated
April 14, 2016
Sponsor
University of Valencia
Collaborators
INCLIVA
1. Study Identification
Unique Protocol Identification Number
NCT02734225
Brief Title
Influences of Balance Training With a Dynamometric Platform in Total Knee Arthroplasty
Acronym
TKA_DP
Official Title
Valoración de la Puesta en Marcha en Artroplastias Totales de Rodilla Mediante un Trabajo Postural en Plataforma Dinamometrica
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
INCLIVA
4. Oversight
5. Study Description
Brief Summary
Knee osteoarthritis produces degeneration and joint wear that greatly affects the patient's proprioceptive system increasing instability. After total knee arthroplasty intervention, it is recommended that the patient performs a rehabilitation procedure to minimize deficits caused by surgery. In this job it is essential to insist on the importance of recovering balance after total knee arthroplasty intervention, and assess a specifically designed protocol to restore its function. An intervention which includes a dynamometric platform as a training method was proposed. The randomized clinical trial compared a control group that performed balance exercises on parallel bars, unstable plates, ramps and stairs against an experimental group that included dynamometric platforms training as a differentiator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
total knee replacement, total knee arthroplasty, rehabilitation, physical therapy, balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXPERIMENTAL
Arm Type
Experimental
Arm Description
Functional recovery Balance training
Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
Functional recovery Balance training Dynamometric Platform training
Intervention Type
Other
Intervention Name(s)
Functional Recovery
Intervention Description
Rehabilitation protocol based on muscle strengthening with isometric, isotonic and counter-resistance with progressive load exercises. Intervention consisted of warm-up phase with passive, active-assisted and active movements, and a work-out phase
Intervention Type
Other
Intervention Name(s)
Balance Training
Intervention Description
Balance and proprioception training using parallel bars, unstable plates, ramps and stairs
Intervention Type
Other
Intervention Name(s)
Dynamometric Platform Training
Intervention Description
Stability tests, weight changes and stability limits, performing both anterior-posterior and medial-lateral movements simultaneously in some cases
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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
Time Frame
Change from baseline (two weeks after intervention) to after four weeks of training
Secondary Outcome Measure Information:
Title
Functional Reach (cm)
Description
Assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position
Time Frame
Change from baseline (two weeks after intervention) to after four weeks of training
Title
Timed Up and Go Test (s)
Description
Dynamic balance assessment. Also points at the risk of falling. Time of getting up from a chair, walk three meters, come back and sit again, measured in seconds
Time Frame
Change from baseline (two weeks after intervention) to after four weeks of training
Title
Romberg Tests
Description
Total score achieved with open and closed eyes and on firm surface
Time Frame
Change from baseline (two weeks after intervention) to after four weeks of training
Title
Knee Range of Mobility (º)
Description
Knee Range of Mobility (Flexion, Extension) in degrees
Time Frame
Change from baseline (two weeks after intervention) to after four weeks of training
Title
Kendall and Lovet scale
Description
Muscle Balance estimated with with Kendall and Lovet scale (score from 0 to 5)
Time Frame
Change from baseline (two weeks after intervention) to after four weeks of training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 65 and 85.
Subjects with knee osteoarthritis that have not been operated before.
Patients operated with the same total replacement prosthesis.
Patients operated with the same surgical procedure.
Time before intervention over 4 weeks.
Time to start rehabilitation after surgery must be less than 4 weeks.
The Result in Berg scale must be greater than 21, indicating a medium-low risk of falling.
the Result of the Mini-Mental State Examination must be equal or greater than 20, which means they do not have moderate or severe cognitive impairment.
Once the informed consent is read and explained, patients must accept and agree to participate in the study.
Exclusion Criteria:
Patient does no accept sign the informed consent.
Patient with morphological alterations hip or ankle (also knee).
Patient that presents knee flexion out of the range between 70 ° and -20 ° because of the risk posed to suffer a fall.
Patient with suspected deep vein thrombosis.
Patient with post-surgical infection of the operated knee.
Patient with psychiatric disorders: depression, anxious syndrome, etc.
Patient with pathology of central origin (i.e. cerebellar) that could interfere with the results of the test of balance or strength
Patient with vestibular pathology that could interfere with the results of the test of balance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Roig-Casasús, Dr
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Influences of Balance Training With a Dynamometric Platform in Total Knee Arthroplasty
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