Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000643471
Ethics application status
Approved
Date submitted
12/12/2007
Date registered
19/12/2007
Date last updated
6/08/2019
Date data sharing statement initially provided
6/08/2019
Date results information initially provided
6/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to evaluate the effectiveness of exercise in the treatment of cervical dystonia.
Scientific title
A randomized controlled trial to determine the effectiveness of a programme of active and passive exercies in the treatment of idiopathic cervical dystonia.
Secondary ID [1] 298955 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CD_EXS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Cervical Dystonia 2584 0
Condition category
Condition code
Neurological 2763 2763 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active exercise group. This group will attend 8 treatment sessions (of approximately 30 minutes duration) over 12 weeks with a physiotherapist. During these sessions participants will perform initially some passive exercises, and then mostly active exercises including cervical spine retraction, flexion, rotation and lateral flexion. Participants will be trained to perform these exercises in a variety of positions for example in lying, sitting, standing and walking. Relaxation will also be taught to participants, and advice will be given on managing their dystonic neck movements. Participants will continue these exercises at home, and will record their practice in a diary.
Intervention code [1] 2317 0
Rehabilitation
Comparator / control treatment
Passive exercise group. This group will attend 8 treatment sessions (of approximately 30 minutes duration) over 12 weeks with a physiotherapist. During these sessions participants will perform relaxation only. Participants will continue this relaxation at home, and will record their practice in a diary.
Control group
Active

Outcomes
Primary outcome [1] 3565 0
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).
Timepoint [1] 3565 0
At baseline, at 6, 12 and 16 weeks after commencement of treatment.
Secondary outcome [1] 5968 0
Cervical Dystonia Questionnaire (CDQ-24)
Timepoint [1] 5968 0
At baseline, at 6, 12 and 16 weeks after commencement of treatment.
Secondary outcome [2] 6018 0
Beck depression inventory
Timepoint [2] 6018 0
At baseline, at 6, 12 and 16 weeks after commencement of treatment.
Secondary outcome [3] 6078 0
Cervical spine active range of motion in the directions of flexion, extension, left and right rotation and lateral flexion, and suboccipital flexion and extension.
Timepoint [3] 6078 0
At baseline, at 6, 12 and 16 weeks after commencement of treatment.

Eligibility
Key inclusion criteria
Diagnosis of cervical dystonia for at least 6 months, committment to maintain any other medications for cervical dystonia at the same dose for the duration of the study.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any concurrent severe cervical spine condition (eg. severe arthritis).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be done by someone not involved in recruitment or assessment and will occur offsite. Therefore, recruitment staff will be unable to predict any participant's group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer will be used to generate randomisation tables. Block randomisation will be used to allocate participants to treatment groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/10/2006
Actual
6/10/2006
Date of last participant enrolment
Anticipated
Actual
8/11/2010
Date of last data collection
Anticipated
Actual
9/03/2011
Sample size
Target
40
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 329 0
2145

Funding & Sponsors
Funding source category [1] 2808 0
Other
Name [1] 2808 0
NSW Physiotherapy Registration Board
Country [1] 2808 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Hawkesbury Rd, Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 2538 0
University
Name [1] 2538 0
The University of Sydney
Address [1] 2538 0
Faculty of Health Sciences
PO Box 170, Lidcombe, NSW, 1825
Country [1] 2538 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4733 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 4733 0
Westmead Hospital, Hawkesbury Rd, Westmead, NSW, 2145.
Ethics committee country [1] 4733 0
Australia
Date submitted for ethics approval [1] 4733 0
01/10/2005
Approval date [1] 4733 0
18/11/2005
Ethics approval number [1] 4733 0
HREC2005/11/4.11(2233)
Ethics committee name [2] 4763 0
The University of Sydney Human Reseach Ethics Committee
Ethics committee address [2] 4763 0
The University of Sydney, NSW, 2006
Ethics committee country [2] 4763 0
Australia
Date submitted for ethics approval [2] 4763 0
24/02/2006
Approval date [2] 4763 0
02/03/2006
Ethics approval number [2] 4763 0
8991

Summary
Brief summary
This study will assess the effects of an active and passive exercise programme for participants with idiopathic cervical dystonia. Participants will be randomly allocated into either the active or passive exercise group, and will receive 8 treatment sessions with a physiotherapist over 12 weeks. Participants in the active exercise group will also receive advice on controlling their dystonia. The primary outcome measure is the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) which includes assessment of active neck movements, neck control, pain and disability. Secondary outcome measures include active range of motion of all neck movements, quality of life and depression questionnaires. All measures will be conducted prior to commencement of treatment, half way through treatment, at the end of treatment and 1 month after the completion of treatment. The study aims to determine if active exercises are more beneficial in improving neck control, reducing pain, range of movement, quality of life, and than passive exercises. Participants will be given a home exercise programme to be continued throughout the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28188 0
Address 28188 0
Country 28188 0
Phone 28188 0
Fax 28188 0
Email 28188 0
Contact person for public queries
Name 11345 0
Melani Boyce
Address 11345 0
Physiotherapy Department Westmead Hospital Hawkesbury Rd, Westmead, NSW, 2145
Country 11345 0
Australia
Phone 11345 0
+61 2 9845 6500
Fax 11345 0
Email 11345 0
[email protected]
Contact person for scientific queries
Name 2273 0
Dr Colleen Canning
Address 2273 0
School of Physiotherapy Faculty of health Sciences, The University of Sydney, PO Box 170, Lidcombe, 1825
Country 2273 0
Australia
Phone 2273 0
+61 2 93519263
Fax 2273 0
Email 2273 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.