Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000605291
Ethics application status
Approved
Date submitted
31/01/2018
Date registered
18/04/2018
Date last updated
18/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Properties of measures of balance in people with cerebellar ataxia
Scientific title
Responsiveness, validity and reliability of measures of balance in people with cerebellar ataxia: 1 year follow up study
Secondary ID [1] 293924 0
None
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebellar ataxia 306414 0
Condition category
Condition code
Neurological 305502 305502 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
This prospective observational study will assess participants with cerebellar ataxia (any type). All included participants will be followed up for 12 months period.
Intervention code [1] 300193 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304630 0
Berg Balance Scale (BBS). The BBS is a measure of dynamic balance. The measure has 14 items testing balance in sitting and standing positions, with each item scored between 0 and 4. This measure is scored out of 56, higher scores indicating better balance.
Timepoint [1] 304630 0
0 months, 6 months and 12 months (primary time point)
Primary outcome [2] 304631 0
Gait, stance and sit sub-components of the Scale for the Assessment and Rating of Ataxia (SARAbal): These three sub-components of the Scale for the Assessment and Rating of Ataxia (SARA) are relevant to the assessment of balance and are called the SARAbal. Scoring of each sub-component is performance based with higher the score obtained worse the balance due to CA. This measure has a maximum score of 18, of which gait is scored out of 8, 6 for stance and 4 for sitting balance.
Timepoint [2] 304631 0
0 months, 6 months and 12 months (primary time point)
Primary outcome [3] 304632 0
Sensory Organization Test (SOT): Is a laboratory based assessment for testing sensory interaction in maintaining balance. The SOT will be assessed using the Bertec ® system. Balance will be tested across six sensory conditions having a combination of occluded vision, visual reference and sway surface. The participant will be instructed to stand still in each condition lasting for 20 seconds. Among the variables available we will consider (1) equilibrium score using the centre of gravity (COG) sway of each condition, (2) composite equilibrium score and (3) sensory analysis ratio to identify deficits of individual sensory systems.
Timepoint [3] 304632 0
0 months, 6 months and 12 months (primary time point)
Secondary outcome [1] 342632 0
Scale for the Assessment and Rating of Ataxia: Is a measure for rating severity of ataxia. The measure has eight sub-components. The scoring is not equal across the sub-components. The measure has a total score of 40, with higher the score obtained, severe the symptoms due to ataxia.

Timepoint [1] 342632 0
0 months, 6 months and 12 months
Secondary outcome [2] 342952 0
Barthel Index: Is a self-reported ordinal scale that measures the level of independence in activities of daily living (ADL). Ten common items of ADL are rated between 0 and 15. The scoring across the testing items are not even. The scale has a maximum score of 100 and a minimum of 0. Higher the score obtained indicating better independence in ADL.
Timepoint [2] 342952 0
0 months, 6 months and 12 months
Secondary outcome [3] 342953 0
EuroQol 5 dimension 5 level (EQ5D 5L): Is a standardized measure of health status that can be used for economic appraisal. This self-rated questionnaire includes 5 questions addressing 5 domains (mobility, self-care, usual activities, pain and anxiety), each domain scored based on a five level index. Level 1 implies “no problem” and 5 indicates “extreme problem”. This measure also has a visual analogue scale to rate the overall health status ranging between 0 and 100, where 0 implies to the worst health one can imagine and 100 being the best health status.
Timepoint [3] 342953 0
0 months, 6 months and 12 months
Secondary outcome [4] 343458 0
Limits of Stability (LOS): This laboratory-based assessment measures dynamic and functional stability. The LOS will be assessed using the Bertec Balance Advantage® system. Participants stand on a computerized dual platform and view their centre of pressure (COP) on the display screen. The test requires the participant to shift their COP by moving their trunk in eight different directions without altering their foot position as well as maintaining their balance. The screen indicates the direction of the target and the COP path as they move. Reaction time (RT) and maximum excursion (MxE) for four directions (front, back, right and left) were considered for analysis. RT represents the time interval between the onset of movement and the prompt to initiate movement provided by the Bertec system. RT is measured in seconds, lesser the score better the movement initiation. MxE is an indicator of maximum displacement of the COP in a given direction without altering the foot position or loosing balance. The MxE is reported in percentage where 100% indicates perfect COP displacement in comparison to age matched healthy peers.
Timepoint [4] 343458 0
0 months, 6 months and 12 months

Eligibility
Key inclusion criteria
People with Spinocerebellar ataxia (all sub-types) and other types of cerebellar ataxia in the age group of 18-65 years - Presence of one or more of the following symptoms of ataxia: Gait ataxia: identified by an inability or instability to perform tandem walking; Limb ataxia: identified by dysdiadochokinesia (inability to perform rapid alternating hand movement), and dysmetria (inability to perform accurately the finger to nose test and the heel on shin test); Dysarthria: scanning speech; Nystagmus
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with cognitive and severe visual impairments - People who do not have access to the data collection centre

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive data of the participants including the mean, standard deviation (SD) and range of age, disease duration and age at disease onset will be calculated. In addition, the proportion of ethnicity distribution, employment status, and assistive walking device use among participants will be established. Non-parametric tests will be used for the ordinal scales (BBS, and SARABal). Parametric tests will be used for objective balance measures including variables of SOT and LOS. To estimate the responsiveness of the measures, area under the curve (AUC) will be plotted using the receiver operating characteristics (ROC) curve. Change of score will be correlated with the functional status (Barthel Index) and disease severity scales (SARA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2018
Date of last participant enrolment
Anticipated
30/04/2018
Actual
Date of last data collection
Anticipated
30/04/2019
Actual
Sample size
Target
25
Accrual to date
15
Final
Recruitment outside Australia
Country [1] 9541 0
Hong Kong
State/province [1] 9541 0
Kowloon

Funding & Sponsors
Funding source category [1] 298552 0
University
Name [1] 298552 0
Hong Kong Polytechnic University
Country [1] 298552 0
Hong Kong
Primary sponsor type
University
Name
Hong Kong Polytechnic University
Address
Room ST514
1 Yuk Choi Road,
Department of Rehabilitation Sciences,
Hong Kong Polytechnic University,
Hung Hom
Kowloon
Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 297700 0
None
Name [1] 297700 0
Address [1] 297700 0
Country [1] 297700 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299521 0
Human Subjects Ethics application review System’
Ethics committee address [1] 299521 0
Ethics committee country [1] 299521 0
Hong Kong
Date submitted for ethics approval [1] 299521 0
08/01/2018
Approval date [1] 299521 0
01/02/2018
Ethics approval number [1] 299521 0
HSERS0245

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80706 0
Dr Stanley Winser
Address 80706 0
ST514,
1, Yuk Choi street,
Department of Rehabilitation Sciences
Hong Kong Polytechnic University,
Kowloon
Hung Hom,
Hong Kong
Country 80706 0
Hong Kong
Phone 80706 0
+85227666746
Fax 80706 0
Email 80706 0
[email protected]
Contact person for public queries
Name 80707 0
Stanley Winser
Address 80707 0
ST514,
1, Yuk Choi street,
Department of Rehabilitation Sciences
Hong Kong Polytechnic University,
Hung Hom
Kowloon
Hong Kong
Country 80707 0
Hong Kong
Phone 80707 0
+85227666746
Fax 80707 0
Email 80707 0
[email protected]
Contact person for scientific queries
Name 80708 0
Stanley Winser
Address 80708 0
ST514,
1, Yuk Choi street,
Department of Rehabilitation Sciences
Hong Kong Polytechnic University,
Hung Hom
Kowloon
Hong Kong
Country 80708 0
Hong Kong
Phone 80708 0
+85227666746
Fax 80708 0
Email 80708 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseValidity of balance measures in cerebellar ataxia: A prospective study with 12-month follow-up.2023https://dx.doi.org/10.1002/pmrj.12826
N.B. These documents automatically identified may not have been verified by the study sponsor.