Knee OsteoarthritisTKA_DPNCT02734225
Influences of Balance Training With a Dynamometric Platform in Total Knee Arthroplasty
A study testing Functional Recovery, Balance Training and Dynamometric Platform Training in people with Knee Osteoarthritis, run by University of Valencia.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Functional Recovery, Balance Training and Dynamometric Platform Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
About this study
Official title: Valoración de la Puesta en Marcha en Artroplastias Totales de Rodilla Mediante un Trabajo Postural en Plataforma Dinamometrica
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
- Being tested
- Functional Recovery, Balance Training, Dynamometric Platform Training
- Keywords
- total knee replacement, total knee arthroplasty, rehabilitation, physical therapy, balance
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional RecoveryOther
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 TrainingOther
Balance and proprioception training using parallel bars, unstable plates, ramps and stairs
Dynamometric Platform TrainingOther
Stability tests, weight changes and stability limits, performing both anterior-posterior and medial-lateral movements simultaneously in some cases
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL | Experimental | Functional recovery Balance training Receives: Other: Functional Recovery; Other: Balance Training; Other: Dynamometric Platform Training |
| CONTROL | Active comparator | Functional recovery Balance training Dynamometric Platform training Receives: Other: Functional Recovery; Other: Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline (two weeks after intervention) to after four weeks of training
Secondary outcomes (5)
Functional Reach (cm)
Assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position
Measured: Change from baseline (two weeks after intervention) to after four weeks of training
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
Measured: Change from baseline (two weeks after intervention) to after four weeks of training
Romberg Tests
Total score achieved with open and closed eyes and on firm surface
Measured: Change from baseline (two weeks after intervention) to after four weeks of training
Knee Range of Mobility (º)
Knee Range of Mobility (Flexion, Extension) in degrees
Measured: Change from baseline (two weeks after intervention) to after four weeks of training
Kendall and Lovet scale
Muscle Balance estimated with with Kendall and Lovet scale (score from 0 to 5)
Measured: Change from baseline (two weeks after intervention) to after four weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria INCLIVA
- Responsible party
- Principal investigator, Sergio Roig Casasus, University of Valencia
- Investigators
- Sergio Roig-Casasús, Dr, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734225
- Sponsor's protocol ID
- DP_Balance_TKA
- Acronym
- TKA_DP
- Status last verified
- Apr 2016
- First submitted
- 2 Mar 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valoración de la Puesta en Marcha en Artroplastias Totales de Rodilla Mediante un Trabajo Postural en Plataforma Dinamometrica
- ClinicalTrials.gov ID
- NCT02734225
- Acronym / sponsor ID
- TKA_DP / DP_Balance_TKA
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee replacement, total knee arthroplasty, rehabilitation, physical therapy, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria INCLIVA
- Study start
- Mar 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL | Experimental | Other: Functional Recovery, Other: Balance Training, Other: Dynamometric Platform TrainingFunctional recovery Balance training |
| CONTROL | Active comparator | Other: Functional Recovery, Other: Balance TrainingFunctional recovery Balance training Dynamometric Platform training |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional RecoveryRehabilitation 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 | Other | CONTROL, EXPERIMENTAL |
| Balance TrainingBalance and proprioception training using parallel bars, unstable plates, ramps and stairs | Other | CONTROL, EXPERIMENTAL |
| Dynamometric Platform TrainingStability tests, weight changes and stability limits, performing both anterior-posterior and medial-lateral movements simultaneously in some cases | Other | EXPERIMENTAL |
Primary outcome
Berg Balance Scale
Time frame: Change from baseline (two weeks after intervention) to after four weeks of training
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
5 secondary outcomes
Functional Reach (cm)
Time frame: Change from baseline (two weeks after intervention) to after four weeks of training
Timed Up and Go Test (s)
Time frame: Change from baseline (two weeks after intervention) to after four weeks of training
Romberg Tests
Time frame: Change from baseline (two weeks after intervention) to after four weeks of training
Knee Range of Mobility (º)
Time frame: Change from baseline (two weeks after intervention) to after four weeks of training
Kendall and Lovet scale
Time frame: Change from baseline (two weeks after intervention) to after four weeks of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Roig-Casasús, Dr principal investigator
University of Valencia
Questions about this trial
What is this clinical trial studying?
A study testing Functional Recovery, Balance Training and Dynamometric Platform Training in people with Knee Osteoarthritis, run by University of Valencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Change from baseline (two weeks after intervention) to after four weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.