Influences of Balance Training With a Dynamometric Platform in Total Knee Arthroplasty

NCT02734225 | Completed

• 1 other identifier: DP_Balance_TKA
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Keywords

total knee replacement; total knee arthroplasty; rehabilitation; physical therapy; balance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Functional Reach (cm)

  Change from baseline (two weeks after intervention) to after four weeks of training

• Timed Up and Go Test (s)

  Change from baseline (two weeks after intervention) to after four weeks of training

• Romberg Tests

  Change from baseline (two weeks after intervention) to after four weeks of training

• Knee Range of Mobility (º)

  Change from baseline (two weeks after intervention) to after four weeks of training

• Kendall and Lovet scale

  Change from baseline (two weeks after intervention) to after four weeks of training

Study Arms (2)

EXPERIMENTAL

EXPERIMENTAL

Functional recovery Balance training

Other: Functional Recovery; Other: Balance Training; Other: Dynamometric Platform Training

CONTROL

ACTIVE COMPARATOR

Functional recovery Balance training Dynamometric Platform training

Other: Functional Recovery; Other: Balance Training

Interventions

Functional Recovery OTHER

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

CONTROL; EXPERIMENTAL

Balance Training OTHER

Balance and proprioception training using parallel bars, unstable plates, ramps and stairs

CONTROL; EXPERIMENTAL

Dynamometric Platform Training OTHER

Stability tests, weight changes and stability limits, performing both anterior-posterior and medial-lateral movements simultaneously in some cases

EXPERIMENTAL

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead
• Instituto de Investigacion Sanitaria INCLIVA: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Recovery of Function

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Biological Phenomena

Study Officials

• Sergio Roig-Casasús, Dr

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: April 12, 2016
• Study Start: March 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 15, 2016

Record last verified: 2016-04