Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000235505
Ethics application status
Approved
Date submitted
5/06/2006
Date registered
14/06/2006
Date last updated
26/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Regaining the ability to walk outdoors following stroke: the efficacy of the Bobath concept compared to structured task practice.
Scientific title
Regaining the ability to walk outdoors following stroke: the efficacy of the Bobath concept compared to structured task practice.
Secondary ID [1] 263101 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 1212 0
Condition category
Condition code
Stroke 1297 1297 0 0
Ischaemic
Stroke 271030 271030 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A) Bobath Intervention - Intervention Group

Each group receives 6 x 1 hour treatment sessions within a 2 week period.

Therapists must have at least 5 years postgraduate experience and at least two years experience in the fields of rehabilitation or neurology. The therapsit providing Intervention A must have completed a Basic Bobath Course and at least two Advanced Bobath Courses.

During the intervention period the participant does not receive any other physiotherapy aimed at improving mobility, postur, balance or lower limb function.
Intervention code [1] 1126 0
Rehabilitation
Comparator / control treatment
B) Structured task practice - Control Group
Control group
Active

Outcomes
Primary outcome [1] 1772 0
Six minute walk test (modified)
Timepoint [1] 1772 0
The test will be performed prior to commencement of the 6 treatment sessions and following completion of the 6 treatment sessions.
Secondary outcome [1] 3122 0
Berg Balance Scale
Timepoint [1] 3122 0
The test will be performed prior to commencement of the 6 treatment sessions and following completion of the 6 treatment sessions.
Secondary outcome [2] 3123 0
Gait speed
Timepoint [2] 3123 0
The test will be performed prior to commencement of the 6 treatment sessions and following completion of the 6 treatment sessions.
Secondary outcome [3] 3124 0
Stair Climbing speed
Timepoint [3] 3124 0
The test will be performed prior to commencement of the 6 treatment sessions and following completion of the 6 treatment sessions.

Eligibility
Key inclusion criteria
First or recurrent stroke diagnosis, haemorrhage or infarct. Between four weeks and sixteen weeks post stroke at commencement of trial. Currently participating in an inpatient or outpatient rehabilitation program. Able to walk 15 metres indoors on a level surface, with or without an aid, with supervision.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Premorbid mobility limited to walking indoors only. Inability to follow single stage verbal commands with visual prompts sufficient to complete the required assessments. Able to walk safely outdoors without supervision. Mobility disability due primarily to pathologies other than stroke.

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)
Concealed evelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1423 0
Charities/Societies/Foundations
Name [1] 1423 0
St Vincents Health Rsearch Grant
Country [1] 1423 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
St Vincents Health
Address
Victoria Parade Fitzroy 3065 Victoria
Country
Australia
Secondary sponsor category [1] 1251 0
None
Name [1] 1251 0
-
Address [1] 1251 0
Country [1] 1251 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2795 0
St Vincents Health
Ethics committee address [1] 2795 0
Ethics committee country [1] 2795 0
Australia
Date submitted for ethics approval [1] 2795 0
Approval date [1] 2795 0
25/05/2005
Ethics approval number [1] 2795 0
6-05
Ethics committee name [2] 2796 0
Goulburn Valley Health
Ethics committee address [2] 2796 0
Ethics committee country [2] 2796 0
Australia
Date submitted for ethics approval [2] 2796 0
Approval date [2] 2796 0
12/09/2005
Ethics approval number [2] 2796 0
GVH - 04/05
Ethics committee name [3] 2797 0
Kliniken Schmeider in Constanz
Ethics committee address [3] 2797 0
Ethics committee country [3] 2797 0
Germany
Date submitted for ethics approval [3] 2797 0
Approval date [3] 2797 0
Ethics approval number [3] 2797 0

Summary
Brief summary
The purpose of this project is to investigate the effectiveness of physiotherapy treatment interventions aimed at improving ability to walk safely outdoors following stroke. This project is a pilot study that will compare the effectiveness of two physiotherapy interventions for regaining the ability to walk outdoors. The structured task practice is an evidence based approach focusing on repeated practice of the different tasks involved in walking outdoors, such as walking on slopes and crossing gutters. The alternative interventions are based on the Bobath Concept, a treatment approach that focuses on the development of postural stability to improve balance and walking function. Participants for the pilot study will be sought from patients who are currently undergoing rehabilitation (either inpatient or outpatient) following stroke and who have recently achieved the ability to walk with supervision indoors. Thirty participants will be recruited for the pilot study. Participants will have baseline assessments including the adapted six minute walk test, their walking velocity (over the central 6 metres of a 10 metre track), the time taken to ascend and descend a flight of stairs and scores on the Berg Balance Scale (an ordinal scale assessing ability to perform 14 balance tasks) by a blind assessor. Participants will be randomised to either of the two interventions. Patients are blinded to which group they have been randomised. Both interventions will require the participant to attend six one hour physiotherapy sessions over a two week period. In the structured task practice intervention, participants will practice activities such as walking on slopes, going up and down a single step, and walking on uneven ground. In the Bobath Concept intervention, the postural stability of the participant will be assessed and individualised treatment programs established, aimed at improving postural stability. These sessions will include activities in standing and walking to enhance standing balance, patterns of muscle activation and postural responses. The sessions will incorporate some task practice to a maximum of 1/6 of the treatment time. The baseline assessments will be repeated following the intervention stage.Analysis of the pilot data will enable accurate power calculations for a larger multi centre trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36277 0
Address 36277 0
Country 36277 0
Phone 36277 0
Fax 36277 0
Email 36277 0
Contact person for public queries
Name 10315 0
Dr Kim Brock
Address 10315 0
Physiotherapy Department
St Vincents Hospital
Victoria Pde
Fitzroy VIC 3065
Country 10315 0
Australia
Phone 10315 0
+61 3 92882211
Fax 10315 0
Email 10315 0
[email protected]
Contact person for scientific queries
Name 1243 0
Dr Kim Brock
Address 1243 0
Physiotherapy Department
St Vincents Hospital
Victoria Pde
Fitzroy VIC 3065
Country 1243 0
Australia
Phone 1243 0
+61 3 92882211
Fax 1243 0
Email 1243 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.