Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000436370
Ethics application status
Approved
Date submitted
19/02/2017
Date registered
24/03/2017
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of consistency of the observational Wisconsin Gait Scale and 3-dimensional gait analysis in patients with central nervous system injuries
Scientific title
Assessment of consistency between components of the observational Wisconsin Gait Scale and 3-dimensional spatiotemporal, kinematic gait parameters and gait indexes such as Gait Deviation Index (GDI) and Gait Variability Index (GVI) in post-stroke and hemiplegic cerebral palsy patients
Secondary ID [1] 291026 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 301813 0
cerebral palsy 302117 0
hemiparesis 302118 0
gait limitations 302119 0
Condition category
Condition code
Stroke 301495 301495 0 0
Ischaemic
Neurological 301735 301735 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 50 patients in the late period after cerebral stroke and 40 patients with hemiplegic cerebral palsy. The study is also going to be conducted in a group of 60 healthy persons in order to calculate the gait indexes such as Gait Deviation Index (GDI) and Gait Variability Index (GVI) which require standard values obtained from the analysis of healthy individuals. The main objective of the study is to compare consistency of observational scale of gait assessment with objective method which is 3-dimensional (3D) gait analysis in patients after stroke and in children as well as youth with hemiplegic cerebral palsy. And thus the answer to the question whether simple, inexpensive, easy to use, observational Wisconsin Gait Scale can fully substitute very costly and require technological knowledge, time and unique equipment 3D gait analysis.
Specific objectives:
- comparison of consistency of spatiotemporal parameters acquired during 3D gait analysis with spatiotemporal traits assessed in part one of WGS, as well as 3D kinematic parameters with the kinematic parameters in part one, two, three and four of WGS
- comparison of results of the observational WGS and the global gait indexes such as GDI and GVI, constituting objective methods of assessing gait taking into account parameters identified during 3D gait analysis
- assessment of inter- and intra-observer reliability of the WGS in observational gait analysis based on the analysis of video recording in children and youth with hemiplegic cerebral palsy and to present the possibility of using this scale in everyday practice in the case of hemiplegic cerebral palsy patients
- examination of correlations between gait assessment performed by means of the WGS and the global gait indexes GDI and GVI and Gross Motor Function Classification Scale (GMFCS)
The patients' gait is going to be assessed with the use of WGS, functional level of children and youth based on GMFCS, spatiotemporal and kinematic gait parameters are going to be examined in Gait Laboratory with the use of BTS Smart system (6 cameras, 120 Hz) from BTS Bioengineering (BTS Bioengineering,Milan, Italy). Reference markers are going to be placed according to the internal protocol of the system (Helen Hayes (Davis) Marker Placement) on the sacrum, pelvis (anterior posterior iliac spine), femur (lateral epicondyle, great trochanter and in lower one-third of the shank), fibula (lateral malleolus, lateral condyle end in lower one-third of the shank), foot (metatarsal head and heel). The subjects are going to walk at their comfortable speed and are going to use auxiliary equipment such as canes and elbow crutches, and tripods during the evaluation. During one study 6 passes of the patient are going to be registered and, subsequently, spatio-temporal and kinematic parameters are going to be calculated with use of Tracker and Analyzer programs (BTS Bioengineering), averaging the results to a single session. The following parameters are going to be analysed: cadency, gait speed, step width, duration of swing phase and duration of stance phase of the paretic and of the non-paretic limb, gait cycle length, step length and kinematic parameters of hip, knee, and ankle joint and pelvis. Furthermore, the global gait indexes GDI and GVI is going to be calculated, which are objective methods of assessing gait taking into account parameters identified during 3D gait analysis. GDI is going to be calculated based on the kinematic parameters and the GVI based on the spatiotemporal parameters. 3D gait recording is going to be performed simultaneously with two video cameras distributed in such a way as to obtain images record in both a frontal plane and a sagittal plane. The video camera filming the view of the frontal plane is going to be located in the middle of the delineated distance, 2 metres away from the route walked by the subject. The camera filming the view of the sagittal plane is going to be placed in line with the route walked. The recording is going to be made for 6 walks, with the minimum of 3 complete gait cycles. The films available for rating and gait assessment provide right and left side, as well as back and front view of the patient. The subjects are going to be instructed to walk the defined distance at self-selected (comfortable) speed, with the support of orthopaedic aids used on a daily basis. Interpretation of the recording and gait assessment based on WGS is going to be performed independently by three experienced physiotherapists, who were trained in gait disorders affecting post-stroke and with hemiplegic cerebral palsy patients, and possess knowledge of assessment criteria used in WGS. Intra-observer reliability of the WGS in the assessment of children and youth with hemiplegic cerebral palsy is going to be done by 3 independent researchers separately analyzing video recording, evaluation results are going to be compared between researchers. Inter-observer reliability of the WGS in the assessment of children and youth with hemiplegic cerebral palsy is going to be done by 3 independent researchers separately twice (two weeks apart) analyzing video recording, evaluation results are going to be compared between the study 1 and 2.
The approximate duration of each of the assessment sessions will amount to 30 minutes for the first session and 30 minutes for the second session for hemiplegic cerebral palsy patients to complete WGS.
Stroke patients will receive a single assessment session only to compare consistency of observational scale of gait assessment with objective method. Hemiplegic cerebral palsy patients will receive two assessments two weeks apart to assess inter-observer reliability of the WGS in observational gait analysis and evaluation results are going to be compared between the study 1 and 2. Inter-observer reliability of the WGS in the hemiplegic cerebral palsy patients aims at presenting the possibility of using this scale in everyday practice in the case of hemiplegic cerebral palsy patients. Single assessment session in patients after stroke results from the fact that the inter-observer reliability of the WGS in this group of patients has already been examined in the previous studies.
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] 297027 0
Not applicable
Comparator / control treatment
Healthy individuals will complete only a single assessment session, including 3D gait analysis based on which the gait indexes such as Gait Deviation Index (GDI) and Gait Variability Index (GVI) will be calculated, which requires standard values obtained from analysis of the healthy individuals. GDI will be calculated based on the kinematic 3D parameters and the GVI based on the spatiotemporal 3D parameters.
The second comparator is 3D gait analysis which constitutes the golden standard in this field since it provides reliable numerical data representing temporal, spatial and kinematic gait parameters.
Control group
Active

Outcomes
Primary outcome [1] 301131 0
Gait assessment with the use of the Wisconsin Gait Scale.
WGS assesses fourteen observable gait parameters, divided into four subscales related to the specific gait phases: stance phase, toe off phase, swing phase and heel strike phase of the affected leg; it also takes into account the use of orthopaedic aids while walking. The specific components of the scale focus on assessment of spatiotemporal (subscale one), as well as kinematic parameters of gait (subscale one, two, three and four). Scores assigned to all the items of the scale are in the range from 1 to 3, except for the first item which is graded from 1 to 5, and the eleventh item graded from 1 to 4. The scores are in the range from 13.35 to 42 points. Higher scores reflect greater gait impairments.
Timepoint [1] 301131 0
Single examination in patients after stroke. Double examination (two weeks apart) in patients with hemiplegic cerebral palsy
Primary outcome [2] 301132 0
Spatial and temporal parameters of gait (step width, gait cycle length, step length, cadency, gait speed, duration of swing phase and duration of stance phase of the paretic and of the non-paretic limb) are going to be assessed by 3D motion analysis system (BTS Smart, BTS Bioengineering, Milan, Italy)
Timepoint [2] 301132 0
Single examination
Primary outcome [3] 301133 0
Kinematic parameters of hip, knee, and ankle joint and pelvis are going to be assessed by 3D motion analysis system (BTS Smart, BTS Bioengineering, Milan, Italy)
Timepoint [3] 301133 0
Single examination
Secondary outcome [1] 331802 0
Gait Deviation Index (GDI), which is objective method of assessing gait taking into account parameters identified during 3D gait analysis. GDI is going to be calculated based on the kinematic parameters
Timepoint [1] 331802 0
Single examination
Secondary outcome [2] 331803 0
Gait Variability Index (GVI), which is objective method of assessing gait taking into account parameters identified during 3D gait analysis. GVI is going to be calculated based on the spatiotemporal parameters
Timepoint [2] 331803 0
Single examination
Secondary outcome [3] 331870 0
The Gross Motor Function Classification System (GMFCS) is tool to describe gross motor function in children with cerebral palsy and has its focus on self-initiated movements, in particular sitting and walking. It is five level system in which level I represents the least limitation and level V the most. Patients based on the observation of the way of movement are going to be classified into one of five levels:
Level I Walks without restrictions, limitations in more advanced gross motor skills
Level II Walks without restrictions, limitations walking outdoors and in the community
Level III Walks with assistive mobility devices, limitations walking outdoors and in community
Level IV Self mobility with limitations, children are transported or use power mobility outdoors and in the community
Level V Self mobility is severely limited, even with use of assistive technology
Timepoint [3] 331870 0
Single examination
Secondary outcome [4] 332409 0
Intra-observer reliability of the WGS in the assessment of children and youth with hemiplegic cerebral palsy is going to be done by 3 independent researchers separately analyzing video recording, evaluation results are going to be compared between researchers.
Timepoint [4] 332409 0
Single examination
Secondary outcome [5] 332410 0
Inter-observer reliability of the WGS in the assessment of children and youth with hemiplegic cerebral palsy is going to be done by 3 independent researchers separately twice (two weeks apart) analyzing video recording, evaluation results are going to be compared between the study 1 and 2
Timepoint [5] 332410 0
Double examination

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. Hemiplegic cerebral palsy patients: hemiplegic cerebral palsy, age 6-18 years, independent gait
3. Healthy individuals: 30 children and youth in the age of 6-18 and 30 adults in the age of 30-75.
Minimum age
6 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2017
Actual
Date of last participant enrolment
Anticipated
1/07/2017
Actual
Date of last data collection
Anticipated
1/08/2017
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 8676 0
Poland
State/province [1] 8676 0
Podkarpackie

Funding & Sponsors
Funding source category [1] 295454 0
University
Name [1] 295454 0
University of Rzeszow
Country [1] 295454 0
Poland
Primary sponsor type
University
Name
University of Rzeszow
Address
University of Rzeszow
Aleja Rejtana 16c
35-959 Rzeszow
Country
Poland
Secondary sponsor category [1] 294276 0
None
Name [1] 294276 0
Address [1] 294276 0
Country [1] 294276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296785 0
The Ethical Committee of University of Rzeszow
Ethics committee address [1] 296785 0
Medical Faculty
Al. mjr. W. Kopisto 2 a
35-310 Rzeszow
Ethics committee country [1] 296785 0
Poland
Date submitted for ethics approval [1] 296785 0
31/01/2017
Approval date [1] 296785 0
09/02/2017
Ethics approval number [1] 296785 0
4/2/2017; 5/2/2017

Summary
Brief summary
The inspiration for research is the fact that in the literature there is scarcity of reports focusing on assessment of correspondence between observational gait scales and objective data, in particular acquired from 3D gait analysis, and the authors underline the importance of these comparisons, suggesting that more research is needed to more comprehensively analyze the psychometric properties of the Wisconsin Gait Scale in patients with diverse neurological disorders, other than stroke. Another reason was the fact that classifications taking into account participation in a social life, activity, as well as secondary alterations children with cerebral palsy are available in the literature but there are few scales focused on multivariate assessment of the walking pattern of children with hemiplegic cerebral palsy.
The main objective of the study is to compare consistency of observational scale of gait assessment with objective method wich is 3D gait analysis and the global gait indexes GDI, GVI in patients after stroke and in children and youth with hemiplegic cerebral palsy. And thus the answer to the question whether simple, inexpensive, easy to use, observational Wisconsin Gait Scale can fully substitute very costly and require technological knowledge, time and unique equipment 3D gait analysis. The objective of the study is also an assessment of inter- and intra-observer reliability of the Wisconsin Gait Scale in observational gait analysis based on the analysis of video recording in children and youth with hemiplegic cerebral palsy and to present the possibility of using this scale in everyday practice in the case of hemiplegic cerebral palsy patients. Research is going to be conducted in gait laboratory 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 children and youth with hemiplegic cerebral palsy who are able to walk unassisted. Gait assessment based on WGS are going to be performed independently by three experienced physiotherapists, with the use of video recordings. Assessment of temporospatial, kinematic parameters and global gait indexes GDI, GVI is going to be based on gait analysis performed with BTS Smart system. Moreover, assessment of functional level of children and youth with hemiplegic cerebral palsy is going to be based on GMFCS. The expected effect of the research has practical dimension, efforts to find a tool that is going to be compared to the objective methods but cheaper, easy to use and available for use in everyday clinical practice.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1462 1462 0 0
http://www.anzctr.org.au/AnzctrAttachments/372248-Ethical Committee 5.pdf (Ethics approval)
Attachments [2] 1463 1463 0 0
http://www.anzctr.org.au/AnzctrAttachments/372248-Ethical Committee 4.pdf (Ethics approval)

Contacts
Principal investigator
Name 72050 0
Dr Agnieszka Guzik
Address 72050 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 72050 0
Poland
Phone 72050 0
+48178721941
Fax 72050 0
+48178721930
Email 72050 0
agnieszkadepa2@wp.pl
Contact person for public queries
Name 72051 0
Dr Agnieszka Guzik
Address 72051 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 72051 0
Poland
Phone 72051 0
+48178721941
Fax 72051 0
+48178721930
Email 72051 0
agnieszkadepa2@wp.pl
Contact person for scientific queries
Name 72052 0
Dr Agnieszka Guzik
Address 72052 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 72052 0
Poland
Phone 72052 0
+48178721941
Fax 72052 0
+48178721930
Email 72052 0
agnieszkadepa2@wp.pl

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