The Postural Control in Patients After Total Hip Replacement

July 12, 2017 updated by: Małgorzata Eliks, Poznan University of Medical Sciences

Does the Total Hip Replacement Impact of Postural Stability?

Total hip replacement (THR) is the procedure which can improve the quality of life in patients with osteoarthritis. However, deficits in static stability and impairment of the lower limb efficiency can be observed even several months after procedure. The aim of this study was to investigate the static balance of the standing position in patients treated by THR.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The balance platform and one leg standing test (OLS) were used to assess the static balance. The postural balance tests were performed on the Metitur Good Balance platform. Static balance tests on balance platform were performed in several position with different foot placement like: normal standing with eyes open (NS EO) and eyes closed (NS EC) position, tandem position (TP), second form of tandem position (2TP) and one leg standing position (1L). Participants were asked to maintain the motionless upright position with both arms at their sides and eyes staring at a target in front of them.

During the normal standing (NS) position the patient stood on the platform barefoot with the feet placed parallelly (symmetric position of feet) with a 20 cm distance between them. The length of the trials with EO and EC was 30 seconds each.

In TP (tandem position) the width of base of support was narrowed down significantly, therefore test lasted only 10 s. During the test in TP one foot was placed directly in the front of the other (on the line) and the heel of the front foot was touched the toes of the rear foot. Tests were performed tests in TP with the left foot in front (TLF) and with right foot in front (TRF) separately. In THR group the placement of the operated limb in the front stance was called the TOF test, while the placement of the non operated limb in the front stance was called the TNF test. The results obtained in TOF position and TNF position were compared with tandem control index (TC - mean of results obtained from control group in TLF and TRF positions).

In 2TP alternately left or right foot was places in front of the other, but the feet were placed on both sides of the line dividing platform to two parts (line was tangent to the medial edge of feet). The length of exercise was 20 s. Analogically to the tandem test, patients were examined with the operated (2TOF) and non operated limb (2 TNF) in the front. Results were compared to the second tandem control index (2TC) representing the mean results of the control group as was described above.

When testing one leg standing position on the balance platform, the patients were asked to raise one foot half the level of the calf of the supporting leg but not touching the stance limb. The trial lasted for 5 s. The test was stopped when the subject used his arms (touched the handrail) or used the raised foot (touched the floor). Usually after 2 failed attempts or fear of falling down procedure was stopped and results was not recording. The results of the patients after THR when standing on the operated (1 O) and non operated (1 N) leg were compared to the index denoting the mean results of the control group (1 C).

During the static tests we analyzed the mean velocity of sway of the center of feet pressure (COP) in the frontal plane (X, mm/s) and in the sagittal plane (Y, mm/s) and the value of the middle of spectrum in the same planes. The spectrum is characterised by two co-dependent variables such as frequency (Hz) and the excursion (mm).

During the one-leg standing test (OLS) the time of maintain this position by the patients was measured. The placement of the limbs was the same as in the case of the balance platform test. Subjects performed 3 trials on each lower limb. Time ended when subject either: loosed balance and touched raised foot the floor, moved supporting leg on the ground, a significant loss of balance or a maximum of 60 s had elapsed. Results achieved by the subjects after THR on both operated (OLS-O) and non operated limbs (OLS-N) were compared with the index of the control group (OLS-C: mean result of the tests performed on the left and right legs).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

59 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • for patients: total hip replacement the minimum of 6 months period since the procedure, age above 55 years, unassisted gait, and the minimum of 9 points on the AMTS scale
  • for healthy volunteers: without total hip replacement age above 55 years, unassisted gait, and the minimum of 9 points on the AMTS scale

Exclusion Criteria:

  • for patients: neurological diseases, muscles diseases, rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) and sciatica. Additionally we excluded patients who had operations in the area of the spine and lower limbs (knee arthroscopy with ACL reconstruction or meniscectomy, total knee replacement, total hip replacement in both extremities, osteotomy or arthrodesis).
  • for healthy volunteers: neurological diseases, muscles diseases, rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) and sciatica. Additionally we excluded patients who had operations in the area of the spine and lower limbs (knee arthroscopy with ACL reconstruction or meniscectomy, total knee replacement, total hip replacement in both extremities, osteotomy or arthrodesis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Individuals after total hip replacement
Individuals after total hip replacement. Patients treated at the Out-Patient Ward of W. Dega Orthopaedic-Rehabilitation Clinical Hospital of Karol Marcinkowski University of Medical Sciences in Poznań. The examination of participants included the static posturography and one-leg standing test.
Other: Static Posturography
The balance platform (Good Balance by Metitur) and one leg standing test (OLS) were used to assess the static balance. OLS test was performed on left and right foot separately. The static posturography was performed with several various positions of feet. Position : normal standing with eyes open and eyes closed - an upright standing with feet placed parallel 20 cm apart for 30 s. Position: tandem - a stance with one foot placed ahead of the other for 10 s. Position: second form of tandem - a stance with one foot placed ahead of the other with feet placed on both sides of the line dividing platform to two parts for 20s. Position: one leg standing: stance on the one leg for 5 s.
Other: One-leg standing test (OLS)
During the one-leg standing test (OLS) the time of maintain this position by the patients was measured. The placement of the limbs was the same as in the case of the balance platform test. Subjects performed 3 trials on each lower limb. Time ended when subject either: loosed balance and touched raised foot the floor, moved supporting leg on the ground, a significant loss of balance or a maximum of 60 s had elapsed. Results achieved by the subjects after THR on both operated (OLS-O) and non operated limbs (OLS-N) were compared with the index of the control group (OLS-C: mean result of the tests performed on the left and right legs).
Active Comparator: control group
The group with healthy individuals; without total hip replacement. The examination of participants included the static posturography and one-leg standing test.
Other: Static Posturography
The balance platform (Good Balance by Metitur) and one leg standing test (OLS) were used to assess the static balance. OLS test was performed on left and right foot separately. The static posturography was performed with several various positions of feet. Position : normal standing with eyes open and eyes closed - an upright standing with feet placed parallel 20 cm apart for 30 s. Position: tandem - a stance with one foot placed ahead of the other for 10 s. Position: second form of tandem - a stance with one foot placed ahead of the other with feet placed on both sides of the line dividing platform to two parts for 20s. Position: one leg standing: stance on the one leg for 5 s.
Other: One-leg standing test (OLS)
During the one-leg standing test (OLS) the time of maintain this position by the patients was measured. The placement of the limbs was the same as in the case of the balance platform test. Subjects performed 3 trials on each lower limb. Time ended when subject either: loosed balance and touched raised foot the floor, moved supporting leg on the ground, a significant loss of balance or a maximum of 60 s had elapsed. Results achieved by the subjects after THR on both operated (OLS-O) and non operated limbs (OLS-N) were compared with the index of the control group (OLS-C: mean result of the tests performed on the left and right legs).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of mean COP velocity in anteroposterior and mediolateral directions during stance in subjects.
Time Frame: 6 months

Mean COP velocity [mm/s] and the value of the middle of spectrum [Hz; mm] is recorded in anteroposterior (AP) and mediolateral (ML) directions within posturographic evaluation in examination of every participant

Evaluation of mean COP velocity in anteroposterior and mediolateral directions during stance in subjects. Mean COP velocity [mm/s] and the value of the middle of spectrum [Hz; mm] is recorded in anteroposterior (AP) and mediolateral (ML) directions within posturographic evaluation in examination of every participant
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of the time of maintain one-leg standing position by the patients.
Time Frame: 6 months

The time of maintain one-leg standing position on each limb is assessed in every participants.

The result is expressed in seconds [s]. The time of maintain one-leg standing position on each limb is assessed in every participants.

The result is expressed in seconds [s].
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Przemysław Lisiński, PhD, Prof., Poznan University of Medical Sciences
  • Principal Investigator: Agnieszka Wareńćzak, PhD, Poznan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 949/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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