ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000384257

Ethics application status

Approved

Date submitted

28/02/2018

Date registered

14/03/2018

Date last updated

23/12/2021

Date data sharing statement initially provided

20/02/2019

Date results provided

23/12/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

An observational study of functional screening tests in people with cervical dystonia.

Scientific title

An observational study of functional screening tests in people with cervical dystonia

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cervical dystonia

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Participants will be screened by a neurologist for eligibility to join the study at their routine clinic appointment for Botox injections. Participants will then complete the study at Westmead Hospital in the same week as their Botox injection. Participants will have baseline measures of dystonia severity, current levels of exercise, cognition and involvement of the cerebellum assessed using the Toronto Western Spasmodic Rating Scale (TWSTRS), the Incidental and Planned Exercise Questionnaire (IPEQ), the Montreal Cognitive Assessment (MoCA) and the Scale for the Assessment and Rating of Ataxia (SARA). Participants will be assessed by 2 physiotherapists on the following standardised physical assessments of balance, walking and upper arm function:

Functional Gait Assessment (formerly Dynamic Gait Index)
Balance Evaluation Systems Test - MiniBEST
5 x sit to stand test
4 squares step test
Figure of Eight test – time to walk a standardized figure of eight
Box and Block test
Coin rotation test

Participants will also complete 2 questionnaires assessing fear of falling and balance confidence as follows:

Activities Balance Confidence Scale (self-reported item)
Falls self-efficacy international scale (self-reported item)

Assessments will take approximately 2 hours to complete.

Participants who are able will repeat the assessment on a second occasion within one week of the botox injection. Participants will then be asked to keep a falls diary for the following 6 months.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Standing balance assessed using the MiniBEST test.

Timepoint [1]

Measures repeated twice in the week surrounding a botox injection

Primary outcome [2]

Gait assessed using the Functional Gait Assessment.

Timepoint [2]

Measures repeated twice in the week surrounding the botox injection

Primary outcome [3]

Fear of falling assessed using the Falls self-efficacy Scale International.

Timepoint [3]

Measures taken once in the week surrounding the botox injection.

Secondary outcome [1]

Incidence of falls in people with cervical dystonia using falls diaries.

Timepoint [1]

6 months following participation in the study

Secondary outcome [2]

Upper limb Function assessed by the Box and Block test.

Timepoint [2]

Measures repeated twice in the week surrounding the botox injection.

Secondary outcome [3]

Standing balance assessed using the 4-square step test.

Timepoint [3]

Primary outcome measure assessed twice in the week surrounding the botox injection.

Secondary outcome [4]

Standing balance assessed by the 5x sit to stand test.

Timepoint [4]

Primary outcome measure assessed twice in the week surrounding the botox injection.

Secondary outcome [5]

Gait assessed by the Figure 8 turn test.

Timepoint [5]

Primary outcome measure assessed twice in the week surrounding the botox injection.

Secondary outcome [6]

Balance confidence assessed by the Activities-specific Balance Confidence Scale.

Timepoint [6]

Primary outcome measure assessed twice in the week surrounding the botox injection.

Secondary outcome [7]

Hand dexterity assessed by the Coin rotation test.

Timepoint [7]

Measures repeated twice in the week surrounding the botox injection.

Eligibility

Key inclusion criteria

Participants will be invited to join the study if they are over 18 years, have been diagnosed with cervical dystonia of unknown cause, can speak English, and are able to walk unaided.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

People with other musculoskeletal or neurological disorders besides dystonia affecting the lower limbs will be excluded.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Considering that cervical dystonia is a rare condition, it will be very difficult to recruit a large number of participants to this study. However given that psychometric analyses of these scales have never before been conducted in people with cervical dystonia, it is worthwhile attempting these analyses with as large a sample size as the study possibly recruits. Given the limited patients in the sampling frame, a pragmatic approach has been adopted. We therefore aim to recruit 30 participants to this study, and assess the reliability and utility of these scales in people with cervical dystonia.
Data will be descriptively analysed as means and standard errors with confidence intervals calculated. Each standardised assessment will be evaluated against normative values and those of other neurological populations using one sample t-tests with the norm as the comparator value.
For intra-rater and test-retest reliabilities, intraclass correlations will be calculated. Spearman correlation coefficients will be used to determine concurrent validity among the functional tests. If the falls data support analysis (ie there are enough fallers to split the data into two groups providing adequate power to conduct a statistical analysis), cut-off points and the minimal detectable difference for each scale will be determined. For cut off points, a descriptive statistic (Shapiro-Wilks) will be performed to determine the distribution and to consider the need for data transformation. Appropriate tests (t test, Mann-Whitney U test, or cross-tabulation chi-square test) will determine which variables differ significantly between fallers and non-fallers. A regression analysis will then be performed using reported falls as the dependent variable with variables that were statistically different between faller and non-faller groups used as independent variables. Sensitivity and specificity in predicting falls status will be calculated, sensitivity is the percentage of the fallers who were correctly identified and specificity is the percentage of non-fallers that were correctly identified. If this analysis cannot be done in the current study, but data support its potential importance, a follow up study will be conducted with identification of risk of falls as the primary objective.

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

Actual

25/05/2017

Date of last participant enrolment

Anticipated

Actual

10/12/2019

Date of last data collection

Anticipated

Actual

16/06/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Westmead Medical Research Foundation

Address [1]

Acacia House,
Westmead Hospital
Hawkesbury Rd,
Westmead, NSW,2145

Country [1]

Australia

Primary sponsor type

Individual

Name

Melani Boyce

Address

Physiotherapy Department
Westmead Hospital
Hawkesbury Rd
Westmead, NSW, 2145

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health DIstrict Human Research and Ethics Committee

Ethics committee address [1]

Research Office
Level 2 REN building
Westmead Hospital
Hawkesbury Rd
Westmead, NSW, 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/10/2016

Approval date [1]

14/11/2016

Ethics approval number [1]

AU RED HREC/16/WMEAD/393

Summary

Brief summary

This study aims to assess balance, function, falls and gait in people with cervical dystonia (CD), using standardized physical assessment scales. 
  
Improving understanding of where people with CD differ from normal in balance and walking will allow targeted physiotherapy interventions to be developed and tested in a subsequent clinical study. Furthermore, the findings will highlight if people with CD present a falls risk similar to other movement disorder populations and provide objective methods of screening.

The study will be observational in design, employing a single group of people living with cervical dystonia and will be conducted at Westmead Hospital.

This study will be conducted at Westmead Hospital, in the Physiotherapy department.
Adults with CD of unknown cause who can walk unaided are invited to join.

Interventions:
 
Participants will be assessed by 2 physiotherapists on a series of physical assessments of balance, walking and upper arm function. Participants will also be asked to complete 3 questionnaires on fear of falling and usual physical activity. The assessment will be conducted in the same week as scheduled Botox injections, to reduce the effect of botox on the assessment results. Participants who are able will be asked to return for a second assessment of the same physical scales within the same week. 

Finally, participants will be asked to complete a falls diary for the next 6 months, noting any falls they have had and the circumstances surrounding the fall

Data will be compared with data from healthy people and data from people with other neurological conditions.  .

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Melani Boyce

Address

Physiotherapy Department
Westmead Hospital
Hawkesbury Rd
Westmead, NSW, 2145

Country

Australia

Phone

+61 2 8890 6500

Fax

melani.boyce@health.nsw.gov.au

Contact person for public queries

Name

Melani Boyce

Address

Physiotherapy Department
Westmead Hospital
Hawkesbury Rd
Westmead, NSW, 2145

Country

Australia

Phone

+61 2 8890 6500

Fax

melani.boyce@health.nsw.gov.au

Contact person for scientific queries

Name

Melani Boyce

Address

Physiotherapy Department
Westmead Hospital
Hawkesbury Rd
Westmead, NSW, 2145

Country

Australia

Phone

+61 2 8890 6500

Fax

melani.boyce@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Individual participant data will not be shared due to privacy reasons.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1410	Informed consent form					373324-(Uploaded-19-02-2019-21-40-39)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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