Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000079741
Ethics application status
Approved
Date submitted
17/01/2013
Date registered
21/01/2013
Date last updated
14/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Reliability and validity of clinic-based outcome measures for the assessment of balance in cerebellar ataxia.
Scientific title
Psychometric property testing of Berg Balance Scale (BBS), Timed Up and Go test (TUG) and Scale for Assessment and Rating of Ataxia (SARA) among people with Cerebellar ataxia.
Secondary ID [1] 281793 0
Nil Known
Universal Trial Number (UTN)
U1111-1138-6242
Trial acronym
CABS (Study on Cerebellar Ataxia Balance Scales)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ataxia due to cerebellar involvement 288117 0
Condition category
Condition code
Neurological 288494 288494 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Berg Balance Scale (BBS), Timed up and Go test (TUG) and Scale for Assessment and Rating of Ataxia (SARA) will be assessed among people with cerebellar ataxia. All the assessment will be prformed once and they will be video taped. The video tape will be re-assessed by an independent researcher to determine the reliability of the scales. The scales will be correlated with each other to determine the convergent validity. Each assessment will take 60 minutes to complete. The data collection is proposed to take place for 12 months.
Intervention code [1] 286337 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288652 0
Berg Balance Scale
Timed Up and Go test (TUG)
Scale for Assessment and Rating of Ataxia (SARA)
Timepoint [1] 288652 0
One time assessment
Secondary outcome [1] 300700 0
Not applicable
Timepoint [1] 300700 0
Not applicable

Eligibility
Key inclusion criteria
Ambulant participants with Multiple sclerosis with cerebellar involvement showing at least one of the following clinical symptoms:
Gait ataxia: identified by an inability or instability to perform tandem walking.
Limb ataxia: identified by dysdiadochokinesia (inability to perform rapid alternating hand movement), Finger to nose test and 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 cerebellar involvement and / or clinical signs of cerebellar ataxia.
Participants with an inability to follow simple commands such as stand or sit for 30 seconds.
Participants with visual impairment who are diagnosed blind.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2013
Actual
20/06/2013
Date of last participant enrolment
Anticipated
20/03/2014
Actual
20/03/2014
Date of last data collection
Anticipated
Actual
20/03/2014
Sample size
Target
50
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 4800 0
New Zealand
State/province [1] 4800 0
Dunidin
Country [2] 4801 0
United States of America
State/province [2] 4801 0
Pennsylvania
Country [3] 4802 0
United Kingdom
State/province [3] 4802 0
London
Country [4] 4812 0
New Zealand
State/province [4] 4812 0
Christchurch
Country [5] 4813 0
New Zealand
State/province [5] 4813 0
Wellington
Country [6] 4814 0
New Zealand
State/province [6] 4814 0
Invercargill.

Funding & Sponsors
Funding source category [1] 286578 0
Charities/Societies/Foundations
Name [1] 286578 0
Neuro Special Interest Group (NSIG), New Zealand
Physiotherapy new Zealand.
Country [1] 286578 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Neuro Special Interest Group (NSIG), New Zealand
Address
Rehab Plus, General Ward, PO Box 44037,
Point Chevalier, Auckland 1246
Country
New Zealand
Secondary sponsor category [1] 285362 0
University
Name [1] 285362 0
University of Otago
Address [1] 285362 0
325, Great King street, School of Physiotherapy, University of Otago, Dunedin, 9016, Otago.
Country [1] 285362 0
New Zealand
Other collaborator category [1] 277250 0
University
Name [1] 277250 0
University of Pittsburgh
Address [1] 277250 0
4200 Fifth Ave Pittsburgh, PA 15213, School of Health and Rehabilitation Sciences, University of Pittsburgh
Country [1] 277250 0
United States of America
Other collaborator category [2] 277251 0
University
Name [2] 277251 0
Anglia Ruskin University
Address [2] 277251 0
Cambridge Campus East Road, Cambridge CB1 1PT, Faculty of Health Social Care and Education, Anglia Ruskin University.
Country [2] 277251 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288655 0
University of Otago Human Ethics Committee
Ethics committee address [1] 288655 0
364 Leith Walk,
Dunedin 9016.

PO Box 56,
Dunedin 9054,
Ethics committee country [1] 288655 0
New Zealand
Date submitted for ethics approval [1] 288655 0
05/02/2013
Approval date [1] 288655 0
24/05/2013
Ethics approval number [1] 288655 0
University of Otago Human Ethics Committee (no 13/041)

Summary
Brief summary
This study has been informed by three previous studies completed by the ‘Study on Cerebellar Ataxia Balance Scales’ (CABS) research team: 1. A narrative review to identify the available outcome measures for the assessment of balance and postural control among people with cerebellar ataxia. 2. A systematic review to identify the psychometric properties of clinic-based outcome measures in this population. 3. A Delphi survey to obtain experts opinion and consensus on appropriate clinic-based outcome measures for the assessment of balance and postural control among the target population. The findings of the systematic review and the Delphi survey has helped us to identify three clinic-based outcome measures that will require further testing in people with cerebellar ataxia. The outcome measures that will be tested for thier psychometric properties included Berg Balance scale (BBS), Timed Up and Go test (TUG) and The Scale for Assessment and Rating of Ataxia (SARA). This programme of work has created a strong theoretical framework and a logical reasoning for the need for this proposed project. The current study aims at investigating the psychometric properties (reliability and validity) of appropriate minimum of three clinic-based balance outcome measures among people with cerebellar ataxia.
Trial website
Trial related presentations / publications
Results of the study are now published.
1. Winser, Stanley, Smith, Catherine, Hale, Leigh, Claydon, Leica & Whitney, Susan. (2017). Clinical assessment of balance using BBS and SARAbal in cerebellar ataxia. Synthesis of findings of a psychometric property analysis. Article in press with ‘Hong Kong Physiotherapy Journal’.
2. Winser, Stanley, Smith, Catherine, Hale, Leigh, Claydon, Leica, Whitney, Susan. Mottershead, John, Zaydan, Islam and & Heyman, Rock. (2017). Psychometric properties of a core set of measures of balance for people with cerebellar ataxia secondary to multiple sclerosis. Achieves of Physical Medicine and Rehabilitation, 98: 270-276.
Public notes
The outcomes of this study will assist clinical practitioners and clinical researchers to choose an appropriate tool that would be psychometrically sound for the assessment of balance in people with cerebellar ataxia.

Contacts
Principal investigator
Name 37130 0
Mr Stanley John Winser
Address 37130 0
325, Great King street, School of Physiotherapy, University of Otago, Dunedin 9026
Country 37130 0
New Zealand
Phone 37130 0
+64 0211735332
Fax 37130 0
Email 37130 0
[email protected]
Contact person for public queries
Name 37131 0
Cath Smith
Address 37131 0
325, Great King street, School of Physiotherapy, University of Otago, Dunedin 9026
Country 37131 0
New Zealand
Phone 37131 0
+64 034797034
Fax 37131 0
Email 37131 0
[email protected]
Contact person for scientific queries
Name 37132 0
Cath Smith
Address 37132 0
325, Great King street, School of Physiotherapy, University of Otago, Dunedin 9026
Country 37132 0
New Zealand
Phone 37132 0
+64 034797034
Fax 37132 0
Email 37132 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

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