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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
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.
Secondary ID [1] 293445 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis 305621 0
stroke 305622 0
hemiplegic gait 305623 0
Condition category
Condition code
Neurological 304844 304844 0 0
Multiple sclerosis
Stroke 304845 304845 0 0
Ischaemic
Neurological 305704 305704 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 300010 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304408 0
Gait assessment with the use of the Wisconsin Gait Scale and Gait Abnormality Rating Scale – modified
Timepoint [1] 304408 0
Baseline, and at two weeks after observation
Secondary outcome [1] 341861 0
Walking speed with the use of 10-metre walk test and 25-foot walk test
Timepoint [1] 341861 0
Baseline, and at two weeks after observation
Secondary outcome [2] 341862 0
Walking distance with the use of 2-min walk test
Timepoint [2] 341862 0
Baseline, and at two weeks after observation
Secondary outcome [3] 341863 0
Self-reliant mobility with the use “Up and Go” test
Timepoint [3] 341863 0
Baseline, and at two weeks after observation
Secondary outcome [4] 341864 0
Balance with the use Berg Balance Scale
Timepoint [4] 341864 0
Baseline, and at two weeks after observation
Secondary outcome [5] 341865 0
Efficiency in terms of activities of functional independence in the Barthel Index and FIM Scale
Timepoint [5] 341865 0
Baseline, and at two weeks after observation
Secondary outcome [6] 341866 0
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
Timepoint [6] 341866 0
Baseline
Secondary outcome [7] 341867 0
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
Timepoint [7] 341867 0
Baseline, and at two weeks after observation

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
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2018
Actual
15/04/2018
Date of last participant enrolment
Anticipated
15/07/2018
Actual
15/07/2018
Date of last data collection
Anticipated
15/08/2018
Actual
15/08/2018
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 9483 0
Poland
State/province [1] 9483 0
Podkarpackie

Funding & Sponsors
Funding source category [1] 298072 0
University
Name [1] 298072 0
University of Rzeszow
Country [1] 298072 0
Poland
Primary sponsor type
University
Name
University of Rzeszow
Address
Aleja Rejtana 16c
35-959 Rzeszow
Country
Poland
Secondary sponsor category [1] 297149 0
None
Name [1] 297149 0
Address [1] 297149 0
Country [1] 297149 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299093 0
The Ethical Committee of University of Rzeszow
Ethics committee address [1] 299093 0
Ethics committee country [1] 299093 0
Poland
Date submitted for ethics approval [1] 299093 0
30/11/2017
Approval date [1] 299093 0
21/12/2017
Ethics approval number [1] 299093 0
2017/12/13
Ethics committee name [2] 299365 0
The Ethical Committee of University of Rzeszow
Ethics committee address [2] 299365 0
Ethics committee country [2] 299365 0
Poland
Date submitted for ethics approval [2] 299365 0
14/12/2017
Approval date [2] 299365 0
11/01/2018
Ethics approval number [2] 299365 0
2018/01/07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2348 2348 0 0
/AnzctrAttachments/374051-Ethics approval 20171213.pdf (Ethics approval)
Attachments [2] 2349 2349 0 0
/AnzctrAttachments/374051-Ethics approval 20180107.pdf (Ethics approval)

Contacts
Principal investigator
Name 79262 0
Dr Agnieszka Guzik
Address 79262 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 79262 0
Poland
Phone 79262 0
+48178721941
Fax 79262 0
+48178721930
Email 79262 0
agnieszkadepa2@wp.pl
Contact person for public queries
Name 79263 0
Agnieszka Guzik
Address 79263 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 79263 0
Poland
Phone 79263 0
+48178721941
Fax 79263 0
+48178721930
Email 79263 0
agnieszkadepa2@wp.pl
Contact person for scientific queries
Name 79264 0
Agnieszka Guzik
Address 79264 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 79264 0
Poland
Phone 79264 0
+48178721941
Fax 79264 0
+48178721930
Email 79264 0
agnieszkadepa2@wp.pl

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No Supporting Document Provided



Results publications and other study-related documents

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