Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000755932
Ethics application status
Approved
Date submitted
19/07/2011
Date registered
19/07/2011
Date last updated
23/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
TRIO: Does targeted rehabilitation improve outcomes after stroke?
Scientific title
TRIO: Does targeted upper limb rehabilitation improve upper limb function and quality of life after stroke?
Secondary ID [1] 262626 0
Nil
Universal Trial Number (UTN)
Trial acronym
TRIO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 268322 0
Condition category
Condition code
Neurological 268453 268453 0 0
Other neurological disorders
Stroke 268493 268493 0 0
Ischaemic
Stroke 268494 268494 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The prognosis group will have a number of measures made, to predict their potential for recovering hand and arm function after stroke. These measures include simple bedside tests of movement, neurophysiological and neuroimaging measures. The simple beside measures of hand and arm strength will be made within 1 week of stroke. The neurophysiological measures involve using transcranial magnetic stimulation to test the pathways from the movement area of the brain to the weak arm muscles. These measures will be made within 2 weeks of stroke. The neuroimaging measures involve a short magnetic resonance imaging (MRI) scan, which will take place within 2 weeks of stroke. This information will be provided to therapy teams and to the patients, to guide rehabilitation planning and goal-setting. Standard rehabilitation therapies will be provided, though the intensity and duration of these therapies may be modified by prognosis information.
Intervention code [1] 266998 0
Rehabilitation
Intervention code [2] 267000 0
Diagnosis / Prognosis
Comparator / control treatment
A benchmark group will be used for comparison. The prognosis measures will also be made in this group, but this information will not be used to plan rehabilitation. This group will be made up of patients recruited in the first 18 months of the study. In the second 18 months of the study, recruited patients will form the prognosis group.
Control group
Historical

Outcomes
Primary outcome [1] 269235 0
Upper limb function, measured with the Action Research Arm Test
Timepoint [1] 269235 0
12 weeks after stroke
Primary outcome [2] 269236 0
Upper limb impairment, measured with the Fugl-Meyer Scale
Timepoint [2] 269236 0
12 weeks after stroke
Primary outcome [3] 269237 0
Upper limb pain-free passive range of motion, measured with goniometry
Timepoint [3] 269237 0
12 weeks after stroke
Secondary outcome [1] 279187 0
Use of the affected upper limb in activities of daily living, measured with the Motor Activity Log
Timepoint [1] 279187 0
6 months after stroke
Secondary outcome [2] 279188 0
Independence in activities of daily living, measured with the modified Rankin Scale
Timepoint [2] 279188 0
6 months after stroke
Secondary outcome [3] 279189 0
Quality of life, assessed with the Stroke Impact Scale
Timepoint [3] 279189 0
6 months after stroke
Secondary outcome [4] 279190 0
Patient satisfaction with the rehabilitation process, measured with a 5-point Likert scale
Timepoint [4] 279190 0
6 months after stroke

Eligibility
Key inclusion criteria
Over 18 years of age
Unilateral upper limb weakness as a result of stroke
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cerebellar stroke
Severe cognitive or communication impairment that precludes informed consent
Contraindications to magnetic resonance imaging or transcranial magnetic stimulation

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be screened for eligibility, provided with information about the study, and enrolled if they provide their written informed consent. Patients enrolled in the first 18 months will form the benchmark group, and patients enrolled in the second 18 months wirll form the prognosis group.
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
Other
Other design features
Patients enrolled in the first 18 months will form the benchmark group, and patients enrolled in the second 18 months wirll form the prognosis group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2012
Actual
26/03/2012
Date of last participant enrolment
Anticipated
Actual
29/10/2015
Date of last data collection
Anticipated
Actual
6/04/2016
Sample size
Target
240
Accrual to date
Final
192
Recruitment outside Australia
Country [1] 3709 0
New Zealand
State/province [1] 3709 0
Auckland

Funding & Sponsors
Funding source category [1] 267475 0
Government body
Name [1] 267475 0
Health Research Council
Country [1] 267475 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 266517 0
Hospital
Name [1] 266517 0
Auckland City Hospital
Address [1] 266517 0
2 Park Rd
Grafton
Auckland 1001
Country [1] 266517 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269440 0
Northern Region Ethics Committee
Ethics committee address [1] 269440 0
Ethics committee country [1] 269440 0
New Zealand
Date submitted for ethics approval [1] 269440 0
20/07/2011
Approval date [1] 269440 0
24/08/2011
Ethics approval number [1] 269440 0

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

Contacts
Principal investigator
Name 32874 0
A/Prof Cathy Stinear
Address 32874 0
Dept of Medicine, University of Auckland
Private Bag 92019
Auckland 1142
Country 32874 0
New Zealand
Phone 32874 0
+6499233779
Fax 32874 0
Email 32874 0
[email protected]
Contact person for public queries
Name 16121 0
Cathy Stinear
Address 16121 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 16121 0
New Zealand
Phone 16121 0
+64 9 92 33 779
Fax 16121 0
Email 16121 0
[email protected]
Contact person for scientific queries
Name 7049 0
Cathy Stinear
Address 7049 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 7049 0
New Zealand
Phone 7049 0
+64 9 92 33 779
Fax 7049 0
Email 7049 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
SourceTitleYear of PublicationDOI
EmbasePredicting Recovery Potential for Individual Stroke Patients Increases Rehabilitation Efficiency.2017https://dx.doi.org/10.1161/STROKEAHA.116.015790
EmbaseProportional Motor Recovery after Stroke: Implications for Trial Design.2017https://dx.doi.org/10.1161/STROKEAHA.116.016020
N.B. These documents automatically identified may not have been verified by the study sponsor.