Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000016639
Ethics application status
Approved
Date submitted
18/07/2005
Date registered
18/07/2005
Date last updated
18/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is task-related circuit training an effective means of providing rehabilitation to an acute stroke sample? A controlled trial.
Scientific title
A controlled trial to evaluate the effectiveness of task-related circuit training in improving motor outcomes in patients receiving inpatient rehabilitation post-stroke.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke patients undergoing inpatient rehabilitation 78 0
Condition category
Condition code
Stroke 95 95 0 0
Physical Medicine / Rehabilitation 96 96 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group circuit class physiotherapy compared to one-to-one physiotherapy
Intervention code [1] 28 0
Rehabilitation
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 122 0
Gait speed
Timepoint [1] 122 0
Measured at week four of, and discharge from, rehabilitation
Secondary outcome [1] 284 0
Berg Balance Scale
Timepoint [1] 284 0
Measured at week four of, and discharge from, rehabilitation.
Secondary outcome [2] 285 0
Patient satisfaction
Timepoint [2] 285 0
Measured at discharge from rehabilitation and at 6 months post-stroke.

Eligibility
Key inclusion criteria
Unilateral motor deficits following acute stroke, previously independent in activities of daily living, able to stand with one person assisting.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects allocated to groups based on time of admission to rehabilitation in ABAB design. SUbjects received allocated type of therapy for duration of inpatient stay and were assessed at admission, week 4, discharge and follow-up.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 130 0
Charities/Societies/Foundations
Name [1] 130 0
Physiotherapy Research Foundation Seeding grant
Country [1] 130 0
Funding source category [2] 131 0
Hospital
Name [2] 131 0
Royal Adelaide Hospital Allied Health grant
Country [2] 131 0
Australia
Funding source category [3] 132 0
Government body
Name [3] 132 0
Australian Post-graduate award.
Country [3] 132 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 94 0
University
Name [1] 94 0
University of South AUstralia
Address [1] 94 0
Country [1] 94 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36030 0
Address 36030 0
Country 36030 0
Phone 36030 0
Fax 36030 0
Email 36030 0
Contact person for public queries
Name 9217 0
Coralie English
Address 9217 0
University of South Australia
North Terrace
Adelaide SA 5000
Country 9217 0
Australia
Phone 9217 0
+61 8 83021373
Fax 9217 0
Email 9217 0
[email protected]
Contact person for scientific queries
Name 145 0
Coralie English
Address 145 0
University of South Australia
North Terrace
Adelaide SA 5000
Country 145 0
Australia
Phone 145 0
+61 8 83021373
Fax 145 0
Email 145 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.