Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000447954
Ethics application status
Approved
Date submitted
19/02/2010
Date registered
3/05/2011
Date last updated
11/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can thoracic kyphosis be reduced in stroke and non stroke adults through postural re-education or strengthening?
Scientific title
The effect of postural re-education and/or progressive resisted strengthening on dynamic thoracic kyphosis measurements in people with and without stroke.
Secondary ID [1] 1412 0
National Health and Medical Research Council (NHMRC) Grant ID 410207
Universal Trial Number (UTN)
U1111-1113-6569
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
thoracic kyphosis 256834 0
stroke 256835 0
Condition category
Condition code
Stroke 256981 256981 0 0
Ischaemic
Musculoskeletal 256982 256982 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions included postural re-education (arm 1), progressive resisted back extension exercise (arm 2), both (arm 3) and control (arm 4).
The intervention period lasted for 12 weeks
Arm 1 - Postural assessment and treatment by a physiotherapist including a home exercise programme. Three 20 - 30 minute sessions over the 12 week period.
Arm 2 - Gym based strengthening programme with one initial instruction and two review sessions by the researcher lasting 20 - 30 minutes. The participants were asked to do their exercise programme of 4 sets of 10 repetitions, 3 times a week for 12 weeks. Each session took approximately 15 minutes.
Arm 3 - Attended the gym and received postural re-education from a physiotherapist as above.
Arm 4 - Received no treatment intervention and were instructed to continue their normal daily routine.
Both normal and stroke groups were randomised to the four intervention groups.
Intervention code [1] 256033 0
Rehabilitation
Comparator / control treatment
The study is a 2X2 factorial design with two interventions (above) and a control. The control has no intervention and no placebo. It is active in that people are generally not given any intervention for the condition.
Control group
Active

Outcomes
Primary outcome [1] 257866 0
Mean Kyphosis angle in standard static positions and over a day.
The static angles were obtained using both the flexible electrogoniometer and the inclinometer in relaxed and upright standing.
The mean measurement for the whole day were obtained over a period of 6 hours using the Flexible Electrogoniometer.
Timepoint [1] 257866 0
Baseline and 12 weeks after randomisation
Primary outcome [2] 257867 0
Range of sagittal thoracic movement over a day from the flexible electrogoniometer data.
Timepoint [2] 257867 0
Baseline and 12 weeks after randomisation
Primary outcome [3] 257868 0
Frequency of thoracic sagittal movement >5 degrees over a day from the flexible electrogoniometer data
Timepoint [3] 257868 0
Baseline and 12 weeks after randomisation
Primary outcome [4] 257869 0
Mode of thoracic angle over the day using the flexible electrogoniometer data collected over the 6 hours
Timepoint [4] 257869 0
Baseline and 12 weeks after randomisation
Primary outcome [5] 257870 0
Motor Assessment Scale for Stroke scores
Timepoint [5] 257870 0
Baseline and 12 weeks after randomisation
Primary outcome [6] 257871 0
Maximum seated extension strength in Newtons measured using a handheld dynamometer mounted on a wall. All measurements were recorded as the best of three. Validation studies conducted prior to the trial confirmed good reliability.
Timepoint [6] 257871 0
Baseline and 12 weeks after randomisation
Secondary outcome [1] 263319 0
10 metre walk time
Timepoint [1] 263319 0
Baseline and 12 weeks after randomisation
Secondary outcome [2] 263320 0
Timed up and go time
Timepoint [2] 263320 0
Baseline and 12 weeks after randomisation
Secondary outcome [3] 263321 0
5 times sit to stand time
Timepoint [3] 263321 0
Baseline and 12 weeks after randomisation
Secondary outcome [4] 263322 0
Chest expansion measurement using a cloth tape measure at the level of the xiphisternum anteriorly and T10 posteriorly. The measurement was made three times and the maximum difference between maximum inspiration and maximum expiration was recorded.
Timepoint [4] 263322 0
Baseline and 12 weeks after randomisation
Secondary outcome [5] 263323 0
Inclinometry measurement of total kyphotic angle
Timepoint [5] 263323 0
Baseline and 12 weeks after randomisation
Secondary outcome [6] 263324 0
Physical Activity Score
Timepoint [6] 263324 0
Baseline and 12 weeks after randomisation
Secondary outcome [7] 263325 0
Australian Quality of Life Survey scores
Timepoint [7] 263325 0
Baseline and 12 weeks after randomisation

Eligibility
Key inclusion criteria
Over 40
Stroke
Non stroke
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 40
Osteoporosis
Serious spinal problems
Unable to walk 10 metres
Pregnancy
Uncontrolled cardiac disease
Neuropathy
Myopathy

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)
Subjects were enrolled via a telephone interview. Random group allocation was made after the baseline assessment using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation to ensure equal population of the four study groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256531 0
Government body
Name [1] 256531 0
NHMRC PhD scholarship
Country [1] 256531 0
Australia
Funding source category [2] 256532 0
Hospital
Name [2] 256532 0
The Canberra Hospital Private Practice Fund
Country [2] 256532 0
Australia
Funding source category [3] 256533 0
Charities/Societies/Foundations
Name [3] 256533 0
AOSpine Asia Pacific
Country [3] 256533 0
China
Primary sponsor type
University
Name
The ANU Medical School
Address
Medical School
Frank Fenner Building 42
The Australian National University
CANBERRA ACT 0200
Australia
Country
Australia
Secondary sponsor category [1] 255839 0
Hospital
Name [1] 255839 0
The Trauma and Orthopaedic Research Unit
Address [1] 255839 0
The Canberra Hospital,
Level 1, Building 6
The Canberra Hospital,
PO Box 11
Woden ACT 2606
Country [1] 255839 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258579 0
ACT Health HREC
Ethics committee address [1] 258579 0
Ethics committee country [1] 258579 0
Australia
Date submitted for ethics approval [1] 258579 0
Approval date [1] 258579 0
01/09/2005
Ethics approval number [1] 258579 0
ETH.6/05.395
Ethics committee name [2] 258580 0
ANU HREC
Ethics committee address [2] 258580 0
Ethics committee country [2] 258580 0
Date submitted for ethics approval [2] 258580 0
Approval date [2] 258580 0
24/04/2007
Ethics approval number [2] 258580 0
2007/94

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

Contacts
Principal investigator
Name 30854 0
Address 30854 0
Country 30854 0
Phone 30854 0
Fax 30854 0
Email 30854 0
Contact person for public queries
Name 14101 0
Diana Perriman
Address 14101 0
The Trauma and Orthopaedic Research Unit
The Canberra Hospital
Level 1, Building 6
The Canberra Hospital
PO Box 11
Woden, ACT 2606
Country 14101 0
Australia
Phone 14101 0
+61 02 62444133
Fax 14101 0
+61 02 6205 2157
Email 14101 0
[email protected]
Contact person for scientific queries
Name 5029 0
Diana Perriman
Address 5029 0
The Trauma and Orthopaedic Research Unit
The Canberra Hospital
Level 1, Building 6
The Canberra Hospital
PO Box 11
Woden, ACT 2606
Country 5029 0
Australia
Phone 5029 0
+61 02 62444133
Fax 5029 0
+61 02 6205 2157
Email 5029 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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