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Trial registered on ANZCTR


Registration number
ACTRN12615001090505
Ethics application status
Approved
Date submitted
23/04/2015
Date registered
16/10/2015
Date last updated
28/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of postural stability in women with hip osteoarthritis
Scientific title
Postural stability in women with hip osteoarthritis using posturography
Secondary ID [1] 286537 0
none
Universal Trial Number (UTN)
U1111-1169-3320
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip osteoarthritis 294861 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295055 295055 0 0
Physiotherapy
Musculoskeletal 295239 295239 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Sixty-six randomly selected women aged between 55-85 years old will be assigned into one of two groups based on age, health status and activity level.

Group 1 will be consisted of 37 women with aged 55 to 85 years old, who will be qualified to treatment for diagnosed bilateral hip osteoarthritis and declaring no systematic physical activity

Group 2 will be consisted of 30 women with aged 60 to 83 years old without degenerative diseases of the lower limb joints, systematically engaging in organized physical exercises. These women will be participated in moderate physical activities such as walking 2-3 times per week for around 30-60 minutes from a minimum 24 months. The absence of degenerative joint disease will be confirmed by standard clinical tests and criteria developed by the American College of Rheumatology.


Participants with hip osteoarthritis will be patients of the Department of Rehabilitation of the Independent Public Central Clinical Hospital in Warsaw.

Pedobarographic measurements will be collected using a WIN-POD Pel 38 electronic podometer and WIN-POD 3.81 software at a frequency (f) of 100 Hz per 30 seconds. To ensure uniform data collection and reliable results, examiners will be asked to adhere to a strict study protocol that included asking participants a series of questions prior to the test about conditions that could adversely affect postural stability. The questions will be designed to assess overall well-being, medication intake, number of hours of sleep, alcohol consumption, history of excessive physical exercise, and current pain or discomfort.

The examination will be consisted of four, 30-second tests with 60-second intermissions in the sitting position. The first two pedobarographic tests will be performed with eyes open (EO) in freestanding posture, whereas the third and fourth tests will be performed with eyes closed (EC). The participants will be asked to remove their shoes and stand upright on the forceplate with the head erect and their arms hanging loosely by their sides. Also they will be asked to stand (barefoot) on a floor-based foot pressure measurement device as pedobarographic balance measurements of deviation length, area and velocity from center of gravity will be recorded. All tests will be conducted in a quiet room with normal temperature and the same illumination.

WIN-POD electronic podometer will be calibrated prior to the recordings and further underwent an automatic calibration check before each trial. Each participant will be only get tested one time.
Intervention code [1] 291641 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294822 0
Primary outcome will be demonstrate the impact of hip osteoarthritis on change in postural stability between study groups.
Timepoint [1] 294822 0
Pedobarographic assessment will be conducted before starting treatment in women with hip osteoarthritis.
Each participant will be underwent a single pedobarographic reading.

single pedobarographic reading consist of four tests (2 x EO and 2 x EC) each readings taken 30 seconds in duration, with 60 seconds intermissions between each reading. During the pedobarographic assessment participants are asked to stand (barefoot) on a electronic podometer,the length (mm), area (mm^2) mean velocity (mm/s) of center of gravity (COG) deviations and foot pressure are collected.
Secondary outcome [1] 314148 0
none
Timepoint [1] 314148 0
none

Eligibility
Key inclusion criteria
Group1: diagnosed hip osteoarthritis; declaring no systematic physical activity, age range of 55-85 years.

Group2: activity level-systematically engaging in organized physical exercises, participated in moderate physical activities such as walking 2-3 times per week for around 30-60 minutes from a minimum 24 months.; no degenerative diseases of the lower limb joints,age range of 60-83 years.
Minimum age
55 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
musculoskeletal pain, advanced foot deformities, intake of analgesic drugs, functional shortening of more than 15 mm of a lower limb, overall poor well-being, declared consumption of alcohol within 24 hours of the test and less than 6 hours of sleep, single/total hip or knee arthroplasty.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size has been computed as follows. We assumed the effect size d=0.82, a err prob = 0.05 and minimum power (1-beta err prob) = 0.90. For the computation of the effect size we took empirical values of mean and standard deviation (SD) for RMScop THA based on the previous studies - value of mean = 3.52 and SD = 1.66 for the RMScop control group and value of mean = 2.42 and SD = 0.94 for the control group.
We assumed that the ratio of the THA group to the control group (allocation ratio) should be 0.8 Computations made with the G*Power 3.0.10 software resulted in the minimum sample size for the treatment group equal to 37 and for the control group equal to 29.
statistical assumptions prepared based on the previous studies
"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.

RMS cop- The rootmean-square (RMS) amplitude of COP (centre of pressure)
THA- total hip arthroplasty (THA)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/10/2015
Actual
22/10/2015
Date of last participant enrolment
Anticipated
29/04/2016
Actual
29/04/2016
Date of last data collection
Anticipated
29/04/2016
Actual
29/04/2016
Sample size
Target
67
Accrual to date
Final
67
Recruitment outside Australia
Country [1] 6819 0
Poland
State/province [1] 6819 0
Warsaw

Funding & Sponsors
Funding source category [1] 291222 0
Self funded/Unfunded
Name [1] 291222 0
Country [1] 291222 0
Primary sponsor type
Individual
Name
Bartosz Slomka
Address
Department of Physiotherapy, Rehabilitation Division, II Faculty of
Medicine, Medical University of Warsaw,Zwirki i Wigury 61, 02-091
Warsaw,Poland.
Country
Poland
Secondary sponsor category [1] 289779 0
None
Name [1] 289779 0
Address [1] 289779 0
Country [1] 289779 0
Other collaborator category [1] 278432 0
Individual
Name [1] 278432 0
Witold Rongies
Address [1] 278432 0
Department of Physiotherapy, Rehabilitation Division, II Faculty of
Medicine, Medical University of Warsaw, Zwirki i Wigury 61, 02-091 Warsaw,Poland.
Country [1] 278432 0
Poland
Other collaborator category [2] 278439 0
Individual
Name [2] 278439 0
Janusz Sierdzinski
Address [2] 278439 0
Department of Medical Information Technology and Telemedicine Medical University of Warsaw, Banacha 1a, 02-097 Warsaw, Poland.
Country [2] 278439 0
Poland
Other collaborator category [3] 278440 0
Individual
Name [3] 278440 0
Marta E Worwag
Address [3] 278440 0
II Faculty of Medicine, Medical University of Warsaw,
Zwirki i Wigury 61, 02-091 Warsaw, Poland.
Country [3] 278440 0
Poland
Other collaborator category [4] 278459 0
Individual
Name [4] 278459 0
Katarzyna Pierchala
Address [4] 278459 0
Department of Otolaryngology Medical University of Warsaw, Banacha 1a, 02-097 Warsaw, Poland.
Country [4] 278459 0
Poland
Other collaborator category [5] 278525 0
Individual
Name [5] 278525 0
Justyna Choromanska
Address [5] 278525 0
Department of Rehabilitation, Independent Public Central Clinical Hospital, Banacha 1a, 02-097 Warsaw, Poland.
Country [5] 278525 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292683 0
Bioethics Committee of the Medical University of Warsaw
Ethics committee address [1] 292683 0
Ethics committee country [1] 292683 0
Poland
Date submitted for ethics approval [1] 292683 0
Approval date [1] 292683 0
02/01/2012
Ethics approval number [1] 292683 0
KB/137/2012

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 524 524 0 0
/AnzctrAttachments/368377-Approval_Bioethics Committee of the Medical University of Warsaw.pdf

Contacts
Principal investigator
Name 56566 0
Mr Bartosz Slomka
Address 56566 0
Department of Physiotherapy, Rehabilitation Division, II Faculty of Medicine, PhD Medical University of Warsaw, Zwirki i Wigury 61, 02-091 Warsaw, Poland.
Country 56566 0
Poland
Phone 56566 0
+48 022 57 20 920
Fax 56566 0
Email 56566 0
slomka.bartosz@interia.pl
Contact person for public queries
Name 56567 0
Witold Rongies
Address 56567 0
Department of Rehabilitation, Independent Public Central Clinical Hospital in Warsaw, Banacha 1a, 02-097 Warsaw,Poland.
Country 56567 0
Poland
Phone 56567 0
+48 604 538 380
Fax 56567 0
Email 56567 0
Rongies@interia.pl
Contact person for scientific queries
Name 56568 0
Janusz Sierdzinski
Address 56568 0
Department of Medical Information Technology and Telemedicine Medical University of Warsaw, Banacha 1a, 02-097 Warsaw, Poland.
Country 56568 0
Poland
Phone 56568 0
+48 022 57 20 920
Fax 56568 0
Email 56568 0
jsierdzinski@wum.edu.pl

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.