Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000227493
Ethics application status
Approved
Date submitted
24/04/2007
Date registered
1/05/2007
Date last updated
1/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving community ambulation after stroke
Scientific title
2 months versus 4 months of walking training to improve community ambulation after stroke
Universal Trial Number (UTN)
Trial acronym
Ambulate
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Individuals who are living in the community after stroke 1758 0
Condition category
Condition code
Stroke 1850 1850 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group 1 - treadmill and overground walking program 3 times per week, 30 minutes per session for 4 months

Intervention group 2 - treadmill and overground walking program 3 times per week, 30 minutes per session for 2 months
Intervention code [1] 1718 0
Rehabilitation
Comparator / control treatment
Control group - no intervention
Control group
Active

Outcomes
Primary outcome [1] 2590 0
10m walk speed
Timepoint [1] 2590 0
Measured at baseline, 2 months, 4 months, 6 months and 12 months
Primary outcome [2] 2591 0
6 minute walk distance
Timepoint [2] 2591 0
Measured at baseline, 2 months, 4 months, 6 months and 12 months
Secondary outcome [1] 4450 0
Falls
Timepoint [1] 4450 0
Measured monthly for 12 months
Secondary outcome [2] 4451 0
Self-efficacy of community ambulation
Timepoint [2] 4451 0
Measured at baseline, 2 months, 4 months, 6 months and 12 months
Secondary outcome [3] 4452 0
Adelaide Activites Profile
Timepoint [3] 4452 0
Measured at baseline, 2 months, 4 months, 6 months and 12 months
Secondary outcome [4] 4453 0
EuroQOL
Timepoint [4] 4453 0
Measured at baseline, 2 months, 4 months, 6 months and 12 months

Eligibility
Key inclusion criteria
Within 5 years of first stroke, able to walk 10m unaided or with a single-point stick, 10m walk time >9 seconds, finished formal rehabilitation, able to gain medical clearance to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any barriers to taking part in a physical rehabilitation program, insufficient cognition/language.

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)
Participant's initial 10m walk speed will be used to match participants into triplets. Each participant within the triplet will be randomly allocated to one of the three groups using opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cohort matching and simple randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 1997 0
Charities/Societies/Foundations
Name [1] 1997 0
National Heart Foundation Grant-in-aid
Country [1] 1997 0
Primary sponsor type
Charities/Societies/Foundations
Name
National Heart Foundation
Address
Country
New Zealand
Secondary sponsor category [1] 1808 0
University
Name [1] 1808 0
Discipline of Physiotherapy, Faculty of Health Sciences, University of Sydney
Address [1] 1808 0
Country [1] 1808 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3704 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 3704 0
Ethics committee country [1] 3704 0
Australia
Date submitted for ethics approval [1] 3704 0
Approval date [1] 3704 0
Ethics approval number [1] 3704 0
USYD 02-2007/9665

Summary
Brief summary
To determine whether 4 months or 2 months of walking training is more effective to improve community ambulation after stroke and whether imrovements are maintained at 12 months
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27821 0
Address 27821 0
Country 27821 0
Phone 27821 0
Fax 27821 0
Email 27821 0
Contact person for public queries
Name 10907 0
Gemma Lloyd
Address 10907 0
Discipline of Physiotherapy
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 10907 0
Australia
Phone 10907 0
+61 2 93519546
Fax 10907 0
+61 2 93519278
Email 10907 0
[email protected]
Contact person for scientific queries
Name 1835 0
Associate Professor Louise Ada
Address 1835 0
Discipline of Physiotherapy
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 1835 0
Australia
Phone 1835 0
+61 2 93519544
Fax 1835 0
+61 2 93519278
Email 1835 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.