Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000539639
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
28/09/2005
Date last updated
28/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Functional Effects of Prism Adaptation Training in Stroke Patients with Spatial Neglect
Scientific title
Functional Effects of Prism Adaptation Training in Stroke Patients with Spatial Neglect
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke patients with hemi-spatial neglect 666 0
Condition category
Condition code
Stroke 739 739 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomly assigned to experimental / control groups. Experimental subjects undergo prism adaptation (PA) training for five sessions over two weeks in addition to usual care. (PA training consists of 30 reaches for targets while wearing 15 degree right deviating prism glasses.)
Double blinded FIM and Catherine Bergego Scale scores are assessed on hospital admission and discharge.
Additional tests include: letter cancellation, figure copying, TUGT walking test, seated reach test, and Fluff test.
Mailed survey follow up at 4 months includes Stroke Impact Scale (SIS-16) and depression screening (CESD-10).
Intervention code [1] 636 0
Rehabilitation
Comparator / control treatment
Control subjects complete the identical procedure but wear sham coloured glasses.
Control group
Placebo

Outcomes
Primary outcome [1] 915 0
1) Functional improvement as measured by change in FIM, and also by the Stroke Impact Scale (SIS-16).
Timepoint [1] 915 0
At discharge and at 4 months follow up.
Primary outcome [2] 916 0
2) Amelioration of neglect impairment as measured by Catherine Bergego Scale, Fluff Test, figure copying, and letter cancellation.
Timepoint [2] 916 0
Secondary outcome [1] 1771 0
1) Effects of PA training on gait and balance as measured by seated reach and TUGT tests on study admission and discharge.
Timepoint [1] 1771 0
Secondary outcome [2] 1772 0
2) Use of health resources (length of stay, FIM efficiency) at discharge.
Timepoint [2] 1772 0
Secondary outcome [3] 1773 0
3) Quality of Life (survey instrument consisting of CESD-10, SIS-16, SIS social subscale, and a VAS-QOL item) four months after discharge.
Timepoint [3] 1773 0

Eligibility
Key inclusion criteria
Stroke occurring within the previous 60 days with clinical evidence of neglect (Bergego >1); Able perform test procedures (patients with hemianopia WILL be included); Medically stable.
Minimum age
55 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Brainstem stroke or subarachnoid hemorrhage; Secondary neurological illness (e.g. Parkinsons, MS); Dementia (MMSE>23).

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)
Group assignment sequence is generated by Excel random number generation, with results recorded in individual sealed envelopes supplied to each participating hospital. Sequence is concealed until subjects have enrolled in the study and completed all baseline assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group assignment sequence is generated by Excel random number generation in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
9/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 820 0
University
Name [1] 820 0
Northern Rivers University Department of Rural Health
Country [1] 820 0
Australia
Funding source category [2] 821 0
University
Name [2] 821 0
University of Sydney
Country [2] 821 0
Australia
Primary sponsor type
University
Name
orthern Rivers University Department of Rural Health
Address
Country
Australia
Secondary sponsor category [1] 686 0
Charities/Societies/Foundations
Name [1] 686 0
Physiotherapy Research Foundation
Address [1] 686 0
Country [1] 686 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2087 0
St. Vincent's Hospital
Ethics committee address [1] 2087 0
Lismore NSW
Ethics committee country [1] 2087 0
Australia
Date submitted for ethics approval [1] 2087 0
Approval date [1] 2087 0
Ethics approval number [1] 2087 0
Ethics committee name [2] 2088 0
Gold Coast Hospital
Ethics committee address [2] 2088 0
Southport QLD
Ethics committee country [2] 2088 0
Australia
Date submitted for ethics approval [2] 2088 0
Approval date [2] 2088 0
Ethics approval number [2] 2088 0

Summary
Brief summary
This study will clarify the effectiveness of prism adaptation treatment for stroke patients with hemi-spatial neglect. The treatment group will undergo five training sessions while wearing prism glasses. The control group will undergo the same procedure while wearing sham glasses. The two groups will be compared for improvements in the neglect impairment and in functional abilities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35686 0
Address 35686 0
Country 35686 0
Phone 35686 0
Fax 35686 0
Email 35686 0
Contact person for public queries
Name 9825 0
Ms Sheila Keane
Address 9825 0
PO Box 3074
Lismore NSW 2480
Country 9825 0
Australia
Phone 9825 0
+61 2 66207570
Fax 9825 0
+61 2 66207270
Email 9825 0
[email protected]
Contact person for scientific queries
Name 753 0
Ms Sheila Keane
Address 753 0
PO Box 3074
Lismore NSW 2480
Country 753 0
Australia
Phone 753 0
+61 2 66207570
Fax 753 0
+61 2 66207270
Email 753 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.