ANZCTR - Registration

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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]

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

Condition category

Condition code

Neurological

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Berg Balance Scale
Timed Up and Go test (TUG)
Scale for Assessment and Rating of Ataxia (SARA)

Timepoint [1]

One time assessment

Secondary outcome [1]

Not applicable

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Dunidin

Country [2]

United States of America

State/province [2]

Pennsylvania

Country [3]

United Kingdom

State/province [3]

London

Country [4]

New Zealand

State/province [4]

Christchurch

Country [5]

New Zealand

State/province [5]

Wellington

Country [6]

New Zealand

State/province [6]

Invercargill.

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Neuro Special Interest Group (NSIG), New Zealand
Physiotherapy new Zealand.

Address [1]

Rehab Plus, General Ward, PO Box 44037,
Point Chevalier, Auckland 1246,

Country [1]

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]

University

Name [1]

University of Otago

Address [1]

325, Great King street, School of Physiotherapy, University of Otago, Dunedin, 9016, Otago.

Country [1]

New Zealand

Other collaborator category [1]

University

Name [1]

University of Pittsburgh

Address [1]

4200 Fifth Ave Pittsburgh, PA 15213, School of Health and Rehabilitation Sciences, University of Pittsburgh

Country [1]

United States of America

Other collaborator category [2]

University

Name [2]

Anglia Ruskin University

Address [2]

Cambridge Campus East Road, Cambridge CB1 1PT, Faculty of Health Social Care and Education, Anglia Ruskin University.

Country [2]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee

Ethics committee address [1]

364 Leith Walk,
Dunedin 9016.

PO Box 56,
Dunedin 9054,

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

05/02/2013

Approval date [1]

24/05/2013

Ethics approval number [1]

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

Mr Stanley John Winser

Address

325, Great King street, School of Physiotherapy, University of Otago, Dunedin 9026

Country

New Zealand

Phone

+64 0211735332

Fax

stanley.winser@otago.ac.nz

Contact person for public queries

Name

Cath Smith

Address

325, Great King street, School of Physiotherapy, University of Otago, Dunedin 9026

Country

New Zealand

Phone

+64 034797034

Fax

cath.smith@otago.ac.nz

Contact person for scientific queries

Name

Cath Smith

Address

325, Great King street, School of Physiotherapy, University of Otago, Dunedin 9026

Country

New Zealand

Phone

+64 034797034

Fax

cath.smith@otago.ac.nz

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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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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