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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00222339




Registration number
NCT00222339
Ethics application status
Date submitted
13/09/2005
Date registered
22/09/2005
Date last updated
22/09/2005

Titles & IDs
Public title
Task-Related Training of Arm Use After Stroke
Scientific title
Task-Related Training of Arm Use After Stroke: a Randomised Controlled Trial
Secondary ID [1] 0 0
H2001/01313
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Arm and hand function measured using the Motor Assessment Scale and the Chedoke-McMaster Impairment Inventory.
Timepoint [1] 0 0
Primary outcome [2] 0 0
Grip and pinch strength measured using dynamometers.
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Dexterity measured using the NK Dexterity Board
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Quality of Life measured using the Stroke-adapted Sickness Impact Profile.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Sensation using a validated assessment of tactile spatial resolution.
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
* within 6 weeks of first stroke
* unilateral stroke
* impaired arm function
* able to cope with intensive training program
* medically stable
* able to understand instructions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* uncontrolled systemic disease
* significant musculotendinous or bony restrictions of the affected upper limb
* any serious chronic disease independently causing significant disability of the affected 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)
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
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Mary P Galea, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

TypeCitations or Other Details
Journal Miller K, Galea M, Kilbreath S, Phillips B (2002) ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00222339