Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03218267
Other study ID # 949/14
Secondary ID
Status Completed
Phase N/A
First received July 10, 2017
Last updated July 12, 2017
Start date September 1, 2014
Est. completion date May 1, 2016

Study information

Verified date July 2017
Source Poznan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 1, 2016
Est. primary completion date September 1, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 59 Years to 83 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Poznan University of Medical Sciences

References & Publications (8)

Balogun JA, Ajayi LO, Alawale F. Determinants of single limb stance balance performance. Afr J Med Med Sci. 1997 Sep-Dec;26(3-4):153-7. — View Citation

Calò L, Rabini A, Picciotti PM, Laurino S, Passali GC, Ferrara PE, Maggi L, Piazzini DB, Specchia A, Frasca G, Ronconi G, Bertolini C, Scarano E. Postural control in patients with total hip replacement. Eur J Phys Rehabil Med. 2009 Sep;45(3):327-34. Epub 2009 Feb 11. — View Citation

Lui RC, Johnson FE, Horovitz JH, Cunningham JN Jr. Aortoesophageal fistula: case report and literature review. J Vasc Surg. 1987 Oct;6(4):379-82. Review. — View Citation

Nantel J, Termoz N, Ganapathi M, Vendittoli PA, Lavigne M, Prince F. Postural balance during quiet standing in patients with total hip arthroplasty with large diameter femoral head and surface replacement arthroplasty. Arch Phys Med Rehabil. 2009 Sep;90(9):1607-12. doi: 10.1016/j.apmr.2009.01.033. — View Citation

Rougier P, Belaid D, Cantalloube S, Lamotte D, Deschamps J. Quiet postural control of patients with total hip arthroplasty following joint arthritis. Motor Control. 2008 Apr;12(2):136-50. — View Citation

Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. J Geriatr Phys Ther. 2007;30(1):8-15. — View Citation

Truszczynska A, Drzal-Grabiec J, Rapala K, Gmitrzykowska E. Postural stability in patients with osteoarthritis of the hip. Pilot study. Ortop Traumatol Rehabil. 2013 Nov-Dec;15(6):567-73. doi: 10.5604/15093492.1091512. — View Citation

Wykman A, Goldie I. Postural stability after total hip replacement. Int Orthop. 1989;13(4):235-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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 Evaluation of the time of maintain one-leg standing position by the patients. 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
See also
  Status Clinical Trial Phase
Completed NCT04774562 - The Effect of Video-Assisted Discharge Education After Total Hip Replacement Surgery N/A
Recruiting NCT02793934 - The Pilot Project Development Of MEdical Rehabilitation System in Russian Federation
Completed NCT02554149 - Radiological Measurement of Femoral Stem Version Using Lateral Decubitus Method: A Prospective Study N/A
Completed NCT01228162 - Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation Phase 4
Completed NCT00219921 - Postoperative Analgesia After Total Hip Replacement Phase 3
Completed NCT02644096 - Rehabilitation of Patients After THR - Based on Patients´Selfrated Health Phase 1
Completed NCT02720471 - Local Analgesia Versus Local Peroperative Infiltration After Total Hip Replacement Phase 3
Recruiting NCT03120312 - Short Term and Long Term Outcome for Elderly Patients Treated With Total Hip Replacement
Withdrawn NCT01523418 - Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement) N/A
Recruiting NCT01782859 - Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery N/A
Completed NCT00889148 - Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study N/A
Completed NCT05375565 - Comparative Effects of Weight Bearing and Non-weight Bearing Exercises in Patients With Total Hip Replacement N/A
Completed NCT04166539 - Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty
Completed NCT03072706 - Evaluation of X-ray, Acetabular Guides and CT in THR N/A
Not yet recruiting NCT02272205 - Evaluation of Conventional Antibiotic Prophylaxis During a Change of Hip or Knee Infected at a Time N/A
Completed NCT01522014 - Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty Phase 4
Completed NCT06169878 - Efficiency of the Adjustable Lower Extremity Abduction Apparatus After Total Hip Replacement Surgery N/A
Not yet recruiting NCT06409312 - Digital Healthcare App After Total Hip Arthroplasty N/A
Recruiting NCT03240484 - Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement
Completed NCT03424382 - CREATION Health Readmission Risk Assessment Tool