Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000970246
Ethics application status
Approved
Date submitted
3/09/2009
Date registered
9/11/2009
Date last updated
17/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving outcomes for the upper limb in severe stroke: the efficacy of rehabilitation interventions based on the Bobath concept - a pilot study
Scientific title
A placebo controlled randomised trial in patients with minimal upper limb control post stroke, comparing physiotherapy utilising the Bobath concept with a sham upper limb physiotherapy intervention, in recovery of reaching movements of the arm.
Secondary ID [1] 263100 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 3300 0
Condition category
Condition code
Stroke 3462 3462 0 0
Haemorrhagic
Stroke 239923 239923 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the experimental group will receive six sessions of one to one treatment with Bobath therapy from a physiotherapist over a two week period, additional to their usual care. The treatment involves therapeutic exercises, focusing on optimising postural stability in body segments, activation of the prime mover muscles of the arm and integration of sensory and perceptual information into tasks. Experimental interventions will be individually prescribed, dependent upon the participant’s presentation.
Intervention code [1] 3039 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control condition will receive six sessions of one to one treatment with a physiotherapist over a two week period, additional to their usual care. The treatment is a sham upper limb intervention including prolonged positioning, placebo Transcutaneous electrical nerve stimulation (TENS) and passive or active assist movements to control for attention to the upper limb. TENS is a small battery operated machine that delivers low voltage electrical currents through the skin. It is routinely used in physiotherapy for the treatment of pain. As a placebo treatment, TENS is applied to the non stroke shoulder and adjusted to the level the patient can just percieve. The TENS is then applied to the affected arm. The patient is informed that the TENS is delivered at a level immediately below the level they could percieve on their intact side. The machine is placed out of sight and turned off during the treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 4363 0
Pre Functional Upper Limb test (PreFUL), a test of reaching ability
Timepoint [1] 4363 0
Prior to commencement of intervention
One day after completion of intervention
Secondary outcome [1] 7357 0
STREAM (Stroke Rehabilitation Assessment of movement)
Timepoint [1] 7357 0
Prior to commencement of intervention
One day after completion of intervention
Secondary outcome [2] 7358 0
Grip strength dynamometry
Timepoint [2] 7358 0
Prior to commencement of intervention
One day after completion of intervention
Secondary outcome [3] 7359 0
Chedoke Arm and Hand Activity Inventory
Timepoint [3] 7359 0
Prior to commencement of intervention
One day after completion of intervention

Eligibility
Key inclusion criteria
4 to 18 weeks post stroke
Able to produce visibly discernable movement in at least one of three movements: shoulder shrug, elbow flexion, finger flexion
ABle to maintain hand placement on table 20cm in front of body
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Able to reach for a cup placed on a table 50cm in front of body
Ataxia
Other medical conditions affecting the upper limb

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)
Participants will be consecutively recruited from in-patient and out-patient rehabilitation units and randomly assigned to experimental and control groups via opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2008
Actual
7/10/2008
Date of last participant enrolment
Anticipated
Actual
2/09/2016
Date of last data collection
Anticipated
Actual
21/09/2016
Sample size
Target
62
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 237573 0
Hospital
Name [1] 237573 0
St Vincent's Hospital
Country [1] 237573 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Victoria Pde,
Fitzroy, 3065
Victoria
Country
Australia
Secondary sponsor category [1] 237048 0
None
Name [1] 237048 0
Address [1] 237048 0
Country [1] 237048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243699 0
St Vincent's Hospital Melbourne Human Research EThics Committee A (HREC A)
Ethics committee address [1] 243699 0
Ethics committee country [1] 243699 0
Australia
Date submitted for ethics approval [1] 243699 0
Approval date [1] 243699 0
26/06/2009
Ethics approval number [1] 243699 0
1/08/0021
Ethics committee name [2] 271892 0
Cairns & Hinterland Health Service District Human Research Ethics Committee (HREC)
Ethics committee address [2] 271892 0
Ethics committee country [2] 271892 0
Australia
Date submitted for ethics approval [2] 271892 0
Approval date [2] 271892 0
21/06/2011
Ethics approval number [2] 271892 0
HREC/11/QCH/65 - 741
Ethics committee name [3] 271893 0
Eastern Health Research and Ethics Committee
Ethics committee address [3] 271893 0
Ethics committee country [3] 271893 0
Australia
Date submitted for ethics approval [3] 271893 0
Approval date [3] 271893 0
05/08/2011
Ethics approval number [3] 271893 0
E65/1011
Ethics committee name [4] 271894 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [4] 271894 0
Ethics committee country [4] 271894 0
Australia
Date submitted for ethics approval [4] 271894 0
Approval date [4] 271894 0
08/08/2011
Ethics approval number [4] 271894 0
2011.111

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

Contacts
Principal investigator
Name 28694 0
Dr Kim Brock
Address 28694 0
ST Vincent's Hospital Victoria Pde, Fitzroy 3065 Victoria
Country 28694 0
Australia
Phone 28694 0
61 3 9459 5864
Fax 28694 0
Email 28694 0
[email protected]
Contact person for public queries
Name 11851 0
Kim Brock
Address 11851 0
ST Vincent's Hospital
Victoria Pde,
Fitzroy 3065
Victoria
Country 11851 0
Australia
Phone 11851 0
61 3 9459 5864
Fax 11851 0
Email 11851 0
[email protected]
Contact person for scientific queries
Name 2779 0
Kim Brock
Address 2779 0
ST Vincent's Hospital
Victoria Pde,
Fitzroy 3065
Victoria
Country 2779 0
Australia
Phone 2779 0
61 3 94595864
Fax 2779 0
Email 2779 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.