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Trial registered on ANZCTR


Registration number
ACTRN12617000327381
Ethics application status
Approved
Date submitted
23/02/2017
Date registered
1/03/2017
Date last updated
21/10/2021
Date data sharing statement initially provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Cost-effectiveness of Tai Chi for improving balance and falls prevention in cerebellar ataxia
Scientific title
Cost effectiveness of Tai Chi for improving balance and falls prevention in cerebellar ataxia: An economic evaluation alongside a randomized controlled trial
Secondary ID [1] 291265 0
Nil
Universal Trial Number (UTN)
Trial acronym
CAATs (Cerebellar Ataxia Assessment and Treatment Trials) project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebellar ataxia 302197 0
Condition category
Condition code
Neurological 301806 301806 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 (intervention group)- Tai Chi ; Group 2 control group
Participants in group 1 will undergo 12 weeks of Tai Chi training at the Department of Rehabilitation Sciences (RS), Hong Kong Polytechnic University (HKPolyU), three times a week and each session lasting for 60 minutes. A Tai Chi Master will be employed to conduct the Tai Chi sessions. The 8-form Tai Chi routine will be delivered to the participants by the Tai Chi master. This 8-form Tai Chi has been derived from Yang’s style of the traditional long-form Tai-Chi routine. The 8-form Tai Chi is specifically designed for people having difficulty in standing while practicing Tai-Chi. The participants will be encouraged to continue Tai Chi practice following the 12 weeks of training.
The participants of the usual care control group will receive one session of advice on falls prevention lasting for 30 minutes. No other intervention will be offered. The participants of the usual care control group are free to continue their routine activities over the study period. Participants of both the groups will be instructed not to register for any new exercise programs over the study period.
Intervention code [1] 297273 0
Rehabilitation
Comparator / control treatment
The participants of the usual care control group will receive one session of advice on falls prevention lasting for 30 minutes. No other intervention will be offered. The participants of the usual care control group are free to continue their routine activities over the study period. Participants of all three groups will be instructed not to register for any new exercise programs over the study period.
Control group
Active

Outcomes
Primary outcome [1] 301250 0
Berg Balance Scale (BBS)
Timepoint [1] 301250 0
Week 0, Week 12, 6 months and 12 months
Primary outcome [2] 301251 0
Gait, stance and sit sub-components of the Scale for the Assessment and Rating of Ataxia (SARAbal)
Timepoint [2] 301251 0
week 0, week 12, 6 months and 12 months
Primary outcome [3] 301254 0
EuroQol 5 dimension 5 level (EQ5D 5L)
quality-adjusted life-year (QALY) gain or loss will be estimated using EuroQol 5 dimension 5 level (EQ5D 5L) questionnaire. The EQ 5D 5L 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 “extreme problem”. This measure also has a visual analogue scale to rate the overall health status ranging between 0 and100, where 0 implies to the worst health one can imagine and 100 being the best health status. Permission to use the HK version of the EQ 5D 5L has been obtained and it will be used.
Timepoint [3] 301254 0
Week 0, week 12, 6 months and 12 months
Secondary outcome [1] 332109 0
Sensory Organization Test (SOT)
Timepoint [1] 332109 0
week 0, week 12, 6 months and 12 months
Secondary outcome [2] 332110 0
Scale for the Assessment and Rating of Ataxia (SARA)
Timepoint [2] 332110 0
week, 0, week 12, 6 months and 12 months
Secondary outcome [3] 332111 0
Falls history
Assessing number of falls: Number of falls encountered following intervention will be used to report the frequency of falls. We operationally define fall as an event when the person ends up on the ground or other surfaces due to a trip or any other unintentional activity and a near fall as an unexpected loss of balance that did not result in complete loss of upright standing. The participants will be instructed to record the number of falls and near falls over the follow-up period using the cost and falls dairy.
Timepoint [3] 332111 0
week 12, 6 months and 12 months

Eligibility
Key inclusion criteria
(1) patients with a definite diagnosis of CA due to any underlying cause, (2) not on formal exercise programme, (3) have had at least one fall over the past six months and (4) walk at least 10 metres with or without the support of a walking assistive device.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) previous history of stroke or any other neurological disorders, (2) severe cardio-vascular diseases that might prevent them from participating in exercise, (3) severe degenerative joint diseases causing excessive pain and discomfort, and (4) severe cognitive and visual impairments

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)
An administrator who is not a part of the research team will randomize participants to groups 1or 2 using pre-determined block randomization
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random numbers list will be created by the statistician and each participant will receive a unique number for identification. In order to ensure treatment allocation concealment, the group allocation will not be revealed to the principal investigator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The Research Assistant and the Tai Chi master cannot be blinded to randomization groups because the exercise intervention will be conducted by both of them. The nature of the intervention is such that participant blinding is also impossible.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will be performed using SPSS, version 22.0. Analysis will be conducted blinded for group allocation. Demographic data will be reported as mean and standard deviation for continuous variables and number and percentage for categorical variables. Mean baseline scores between the groups will be compared using independent t-tests. Analysis of covariance (ANCOVA) will be used to compare the clinical outcome measures at 95% confidence interval. ANCOVA has the advantage of comparing clinical outcome measures having significant difference in the baseline values and in addition it improves the statistical power and accuracy even when the baseline differences are small and insignificant.
Cost effectiveness analysis will be performed according to intention-to-treat principle. The EQ 5D 5L (HK version) will be used to estimate the quality-adjusted life-year (QALY) gain or loss over the follow-up period. The mean QALY gain or loss will be calculated for each group at 6 and 12 months.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/04/2017
Actual
30/06/2017
Date of last participant enrolment
Anticipated
31/10/2017
Actual
31/10/2017
Date of last data collection
Anticipated
31/10/2018
Actual
31/10/2018
Sample size
Target
40
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 8688 0
Hong Kong
State/province [1] 8688 0

Funding & Sponsors
Funding source category [1] 295720 0
University
Name [1] 295720 0
The Hong Kong Polytechnic University
Country [1] 295720 0
Hong Kong
Primary sponsor type
Individual
Name
Dr Stanley John Winser
Address
Hong Kong Polytechnic University
No 1, Chatham Road North,
King's Park,
Kowloon,
Hong Kong.
Country
Hong Kong
Secondary sponsor category [1] 294568 0
None
Name [1] 294568 0
Address [1] 294568 0
Country [1] 294568 0
Other collaborator category [1] 279443 0
Individual
Name [1] 279443 0
Author withdrew form the study
Address [1] 279443 0
Dr Haxby Abbott,
Research Associate Professor,
Dunedin public hospital,
201 Great King St,
Orthopaedic Surgery section,
University of Otago,
Dunedin,
New Zealand
Country [1] 279443 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297024 0
Human Subjects Ethics application review System’, HK
Ethics committee address [1] 297024 0
Ethics committee country [1] 297024 0
Hong Kong
Date submitted for ethics approval [1] 297024 0
03/04/2017
Approval date [1] 297024 0
30/06/2017
Ethics approval number [1] 297024 0
HSEARS20170519004

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

Contacts
Principal investigator
Name 72746 0
Dr Stanley John Winser
Address 72746 0
Room ST 514,
Department of Rehabilitation Sciences,
The Hong Kong Polytechnic University,
No 1, Chatham Rd N, King's Park,
Hong Kong
Country 72746 0
Hong Kong
Phone 72746 0
+852 27666746
Fax 72746 0
Email 72746 0
[email protected]
Contact person for public queries
Name 72747 0
Stanley john WInser
Address 72747 0
Room ST 514,
Department of Rehabilitation Sciences,
The Hong Kong Polytechnic University,
No 1, Chatham Rd N, King's Park,
Hong Kong
Country 72747 0
Hong Kong
Phone 72747 0
+852 27666746
Fax 72747 0
Email 72747 0
[email protected]
Contact person for scientific queries
Name 72748 0
Stanley John Wisner
Address 72748 0
Room ST 514,
Department of Rehabilitation Sciences,
The Hong Kong Polytechnic University,
No 1, Chatham Rd N, King's Park,
Hong Kong
Country 72748 0
Hong Kong
Phone 72748 0
+852 27666746
Fax 72748 0
Email 72748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have data from individual participants that could be shared.


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.