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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02734225
Other study ID # DP_Balance_TKA
Secondary ID
Status Completed
Phase N/A
First received March 2, 2016
Last updated April 14, 2016
Start date March 2009
Est. completion date December 2012

Study information

Verified date April 2016
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 65 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Functional Recovery
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
Balance Training
Balance and proprioception training using parallel bars, unstable plates, ramps and stairs
Dynamometric Platform Training
Stability tests, weight changes and stability limits, performing both anterior-posterior and medial-lateral movements simultaneously in some cases

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Valencia INCLIVA

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from baseline (two weeks after intervention) to after four weeks of training No
Secondary Functional Reach (cm) Assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position Change from baseline (two weeks after intervention) to after four weeks of training No
Secondary 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 Change from baseline (two weeks after intervention) to after four weeks of training No
Secondary Romberg Tests Total score achieved with open and closed eyes and on firm surface Change from baseline (two weeks after intervention) to after four weeks of training No
Secondary Knee Range of Mobility (º) Knee Range of Mobility (Flexion, Extension) in degrees Change from baseline (two weeks after intervention) to after four weeks of training No
Secondary Kendall and Lovet scale Muscle Balance estimated with with Kendall and Lovet scale (score from 0 to 5) Change from baseline (two weeks after intervention) to after four weeks of training No
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