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Trial registered on ANZCTR
Registration number
ACTRN12618000494235
Ethics application status
Approved
Date submitted
12/01/2018
Date registered
5/04/2018
Date last updated
20/08/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of the biometric value of observational gait scales - Wisconsin Gait Scale and Gait Abnormality Rating Scale – modified in neurological diseases
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Scientific title
Use of Wisconsin Gait Scale and Gait Abnormality Rating Scale – modified as an observational gait analysis tool in patients with multiple sclerosis or ischemic stroke.
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Secondary ID [1]
293445
0
none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis
305621
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stroke
305622
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hemiplegic gait
305623
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Condition category
Condition code
Neurological
304844
304844
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0
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Multiple sclerosis
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Stroke
304845
304845
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0
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Ischaemic
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Neurological
305704
305704
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0
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Other neurological disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The study is going to be conducted among selected 30 hemiplegic patients with multiple sclerosis and 30 hemiplegic patients after stroke. The objective of the study is to assess inter- and intra-observer reliability of the Wisconsin Gait Scale (WGS) and Gait Abnormality Rating Scale – modified (GARS-M) in observational gait analysis based on the analysis of video recording in hemiplegic patients and to present the possibility of using this scales in everyday practice in the case of hemiplegic multiple sclerosis and post-stroke patients. The study also seeks to examine correlations between gait assessment made with the WGS, GARS-M and walking speed, walking distance, self-reliant mobility, balance and efficiency in terms of activities of functional independence.
The patients' gait is going to be assessed with the use of WGS, GARS-M, walking speed with the use of 10-metre walk test and 25-foot walk test, walking distance in a 2-min walk test, self-reliant mobility with the use “Up and Go” test, balance in Berg Balance Scale and efficiency in terms of activities of functional independence in the Barthel Index and FIM Scale. The subjects’ gait is going to be recorded with two synchronised digital cameras distributed in such a way as to obtain images record in both a frontal plane and a sagittal plane. The walking path is going to be 10 meters long. One camera is going to be aligned in the direction of the gait in the frontal plane, the second camera recording the image in the sagittal plane is going to be halfway up the walking path at a distance of 2 meters from the pathway. The cameras are going to be set up to allow visualization of 3 walking trials examining the unaffected and the affected sides for a total of 6 ambulation trials. The subjects are going to be instructed to walk at the defined distance at self-selected (comfortable) speed, with the support of orthopaedic aids used on a regular basis.
Interpretation of the recording and gait assessment based on WGS and GARS-M is going to be performed independently by three experienced observers (physiotherapists with more than 10 years of experience in working with post-stroke and multiple sclerosis patients) and five inexperienced observers (students of the last year of physiotherapy). All observers are going to be trained in gait disorders affecting post-stroke and with hemiplegic multiple sclerosis patients, and trained in the use and interpretation of the WGS and GARS-M. Intra-observer reliability of the WGS and GARS-M in the assessment of hemiplegic multiple sclerosis and post-stroke patients is going to be done by independent experienced and inexperienced researchers separately analyzing video recording, evaluation results are going to be compared among researchers. Inter-observer reliability of the WGS and GARS-M in the assessment of hemiplegic multiple sclerosis and post-stroke patients is going to be done by independent experienced and inexperienced researchers separately twice (two weeks apart) analyzing video recording, evaluation results are going to be compared between the study 1 (baseline) and 2.
Two studies are going to be conducted and the approximate duration of each of the assessment sessions will amount to 60 minutes for the study 1 and 60 minutes for the study 2. The study 2 will be performed 2 weeks after the study 1 (baseline).
All patients are going to be examined in the same laboratory by the same people and with the use of the same equipment. The observation period is 3 months. The observation period refers to total recruitment of all participants.
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Intervention code [1]
300010
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
304408
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Gait assessment with the use of the Wisconsin Gait Scale and Gait Abnormality Rating Scale – modified
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Assessment method [1]
304408
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Timepoint [1]
304408
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Baseline, and at two weeks after observation
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Secondary outcome [1]
341861
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Walking speed with the use of 10-metre walk test and 25-foot walk test
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Assessment method [1]
341861
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Timepoint [1]
341861
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Baseline, and at two weeks after observation
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Secondary outcome [2]
341862
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Walking distance with the use of 2-min walk test
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Assessment method [2]
341862
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Timepoint [2]
341862
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Baseline, and at two weeks after observation
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Secondary outcome [3]
341863
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Self-reliant mobility with the use “Up and Go” test
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Assessment method [3]
341863
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Timepoint [3]
341863
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Baseline, and at two weeks after observation
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Secondary outcome [4]
341864
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Balance with the use Berg Balance Scale
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Assessment method [4]
341864
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Timepoint [4]
341864
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Baseline, and at two weeks after observation
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Secondary outcome [5]
341865
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Efficiency in terms of activities of functional independence in the Barthel Index and FIM Scale
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Assessment method [5]
341865
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Timepoint [5]
341865
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Baseline, and at two weeks after observation
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Secondary outcome [6]
341866
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Intra-observer reliability of the WGS and GARS-M to be done by independent experienced and inexperienced researchers , evaluation results to be compared between researchers
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Assessment method [6]
341866
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Timepoint [6]
341866
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Baseline
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Secondary outcome [7]
341867
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Inter-observer reliability of the WGS and GARS-M to be done by independent experienced and inexperienced researchers, evaluation results to be compared between the study 1 and 2
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Assessment method [7]
341867
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Timepoint [7]
341867
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Baseline, and at two weeks after observation
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Eligibility
Key inclusion criteria
1. Stroke patients: single ischaemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging, age 30-75 years, time from stroke at least 6 months, unilateral hemiplegia, independent gait
2. Multiple Sclerosis patients: Expanded Disability Status Scale (EDSS) 4-6, age 30-60 years, independent gait
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Minimum age
30
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Second or another stroke incident, cognitive function deficits impairing the ability to understand and follow instructions, unstable medical condition and orthopedic disorders of lower limbs
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/04/2018
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Actual
15/04/2018
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Date of last participant enrolment
Anticipated
15/07/2018
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Actual
15/07/2018
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Date of last data collection
Anticipated
15/08/2018
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Actual
15/08/2018
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment outside Australia
Country [1]
9483
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Poland
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State/province [1]
9483
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Podkarpackie
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Funding & Sponsors
Funding source category [1]
298072
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University
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Name [1]
298072
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University of Rzeszow
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Address [1]
298072
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Aleja Rejtana 16c
35-959 Rzeszow
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Country [1]
298072
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Poland
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Primary sponsor type
University
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Name
University of Rzeszow
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Address
Aleja Rejtana 16c
35-959 Rzeszow
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Country
Poland
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Secondary sponsor category [1]
297149
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None
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Name [1]
297149
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Address [1]
297149
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Country [1]
297149
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299093
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The Ethical Committee of University of Rzeszow
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Ethics committee address [1]
299093
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Medical Faculty
Al. mjr. W. Kopisto 2 a
35-310 Rzeszow
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Ethics committee country [1]
299093
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Poland
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Date submitted for ethics approval [1]
299093
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30/11/2017
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Approval date [1]
299093
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21/12/2017
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Ethics approval number [1]
299093
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2017/12/13
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Ethics committee name [2]
299365
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The Ethical Committee of University of Rzeszow
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Ethics committee address [2]
299365
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Medical Faculty
Al. mjr. W. Kopisto 2 a
35-310 Rzeszow
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Ethics committee country [2]
299365
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Poland
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Date submitted for ethics approval [2]
299365
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14/12/2017
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Approval date [2]
299365
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11/01/2018
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Ethics approval number [2]
299365
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2018/01/07
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Summary
Brief summary
The major problem in gait analysis in hemiparetic post-stroke and multiple sclerosis patients is constituted by the lack of standard research tools used for assessing the results of gait rehabilitation process. The objective of the study is to assess inter- and intra-observer reliability of the Wisconsin Gait Scale (WGS) and Gait Abnormality Rating Scale – modified (GARS-M) in observational gait analysis based on the analysis of video recording in hemiplegic patients and to present the possibility of using this scales in everyday practice in the case of hemiplegic multiple sclerosis and post-stroke patients. The objective of the study is also an examination of correlations between gait assessment made with the WGS, GARS-M and walking speed, walking distance, self-reliant mobility, balance and efficiency in terms of activities of functional independence.
Research is going to be conducted in biomechanics laboratory at University of Rzeszow. Patients recruited to the study are going to be stroke survivors, over 6 months from the onset of ischaemic stroke, who are able to walk unassisted and hemiplegic patients with multiple sclerosis who are able to walk unassisted, EDSS 4,0-6,0. Gait assessment based on WGS and GARS-M are going to be performed independently by three experienced observers (physiotherapists with more than 10 years of experience in working with post-stroke and multiple sclerosis patients) and five inexperienced observers (students of the last year of physiotherapy). Moreover, assessment of walking speed, walking distance, self-reliant mobility, balance and efficiency in terms of activities of functional independence is going to be based on the 10-m walk test, the 25-foot walk test, the 2-min test, “Up and Go” test, the Barthel Index, FIM and Berg Balance Scale.
The expected effect of the research has practical dimension, efforts to find a tool that is going to be inexpensive and easy enough to be used by experienced physiotherapists in clinical practice as well as inexperienced who are just gaining experience.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
2348
2348
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0
/AnzctrAttachments/374051-Ethics approval 20171213.pdf
(Ethics approval)
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Attachments [2]
2349
2349
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/AnzctrAttachments/374051-Ethics approval 20180107.pdf
(Ethics approval)
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Contacts
Principal investigator
Name
79262
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Dr Agnieszka Guzik
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Address
79262
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University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
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Country
79262
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Poland
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Phone
79262
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+48178721941
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Fax
79262
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+48178721930
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Email
79262
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[email protected]
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Contact person for public queries
Name
79263
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Dr Agnieszka Guzik
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Address
79263
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University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
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Country
79263
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Poland
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Phone
79263
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+48178721941
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Fax
79263
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+48178721930
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Email
79263
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[email protected]
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Contact person for scientific queries
Name
79264
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Dr Agnieszka Guzik
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Address
79264
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University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
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Country
79264
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Poland
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Phone
79264
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+48178721941
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Fax
79264
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+48178721930
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Email
79264
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[email protected]
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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.
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