Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000309987
Ethics application status
Approved
Date submitted
27/06/2007
Date registered
23/03/2011
Date last updated
21/01/2022
Date data sharing statement initially provided
21/01/2022
Date results provided
21/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Recovery of the arm after stroke
Scientific title
In acute, very weak stroke patients does electromyographic (EMG) triggered electrical stimulation increase strength and activity in the arm compared to conventional therapy alone?
Secondary ID [1] 259796 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 2127 0
Condition category
Condition code
Stroke 2223 2223 0 0
Ischaemic
Neurological 259537 259537 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group -usual therapy (physiotherapy and occupational therapy interventions including strengthening, cyclical electrical stimulalation, task specific training of reaching and manipulation) and EMG triggered electrical stimulation to 4 major muscles of the upper limb (UL). They will receive the intervention for 5 days a week for 4 weeks.
Intervention code [1] 1602 0
Rehabilitation
Comparator / control treatment
Control group - usual therapy (physiotherapy and occupational therapy interventions including strengthening, cyclical electrical stimulalation, task specific training of reaching and manipulation)
Control group
Active

Outcomes
Primary outcome [1] 3083 0
Muscle strength of the affected arm using hand-held dynamometry and manual muscle testing.
Timepoint [1] 3083 0
Primary outcome measured at baseline (pre-randomisation), and at 4 weeks and 20 weeks
Secondary outcome [1] 5159 0
Activity using the Motor Assessment Scale and Nine Hole Peg test
Timepoint [1] 5159 0
Measured at baseline (pre-randomisation), and at 4 weeks and 20 weeks

Eligibility
Key inclusion criteria
Diagnosis of stroke less than 4 weeks before, medically stable, no previous stroke with residual deficits, previously able to manipulate objects independently, less than grade 3 muscle strength in 3 out of 4 of the following muscle groups of the affected UL , shoulder flexors, elbow extensors, wrist extensors, thumb abductors, have sufficient cognition and communication to understand the purpose of the study and give informed consent.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Demand style cardiac pacemaker, severe receptive aphasia, previous stroke resulting in hemiplegia/ hemiparesis or any barriers to taking part in a physical rehabilitation programme.

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)
After informed consent has been received and the intial measurements completed the group allocation will be determined by ringing a contact person off-site who will open a sealed opaque envelope to inform of group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
External person not involved in recruitment, intervention or measurement will generate the sequence using Excel software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blind assessors
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
2/07/2007
Actual
6/08/2007
Date of last participant enrolment
Anticipated
Actual
25/10/2010
Date of last data collection
Anticipated
Actual
19/11/2010
Sample size
Target
70
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21540 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 21541 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 36447 0
2200 - Bankstown
Recruitment postcode(s) [2] 36448 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 2383 0
Government body
Name [1] 2383 0
NSW Physiotherapists Registration Board, now The Physiotherapy Council of NSW
Country [1] 2383 0
Australia
Funding source category [2] 264678 0
Charities/Societies/Foundations
Name [2] 264678 0
Physiotherapy Research Foundation
Country [2] 264678 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Faculty of Health Sciences
PO Box 170
Lidcombe
NSW 1825
Country
Australia
Secondary sponsor category [1] 263813 0
Hospital
Name [1] 263813 0
Bankstown-Lidcombe Hospital
Address [1] 263813 0
Eldridge Rd
Bankstown
NSW 2200
Country [1] 263813 0
Australia
Secondary sponsor category [2] 263814 0
Hospital
Name [2] 263814 0
St George Public Hospital
Address [2] 263814 0
Gray St
Kogarah
NSW 2217
Country [2] 263814 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4208 0
Sydney South West Area Health Service HREC
Ethics committee address [1] 4208 0
Ethics committee country [1] 4208 0
Australia
Date submitted for ethics approval [1] 4208 0
Approval date [1] 4208 0
29/09/2006
Ethics approval number [1] 4208 0
2006/076
Ethics committee name [2] 4209 0
University of Sydney HREC
Ethics committee address [2] 4209 0
Ethics committee country [2] 4209 0
Australia
Date submitted for ethics approval [2] 4209 0
Approval date [2] 4209 0
03/11/2006
Ethics approval number [2] 4209 0
9655
Ethics committee name [3] 266672 0
Human Research Ethics committee Concord Repatriation General Hospital
Ethics committee address [3] 266672 0
Ethics committee country [3] 266672 0
Australia
Date submitted for ethics approval [3] 266672 0
Approval date [3] 266672 0
20/01/2009
Ethics approval number [3] 266672 0
08/CRGH/164

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

Contacts
Principal investigator
Name 27536 0
Dr Simone Dorsch
Address 27536 0
School of Allied Health
Australian Catholic University
PO Box 968
North Sydney
NSW 2059
Country 27536 0
Australia
Phone 27536 0
+61 414811168
Fax 27536 0
Email 27536 0
[email protected]
Contact person for public queries
Name 10791 0
Ms Simone Dorsch
Address 10791 0
C/O Physiotherapy Department
Bankstown-Lidcombe Hospital
Eldridge Rd
Bankstown NSW 2200
Country 10791 0
Australia
Phone 10791 0
61 414 811 168
Fax 10791 0
61 2 9722 7125
Email 10791 0
[email protected]
Contact person for scientific queries
Name 1719 0
Ms Simone Dorsch
Address 1719 0
C/O Physiotherapy Department
Bankstown-Lidcombe Hospital
Eldridge Rd
Bankstown NSW 2200
Country 1719 0
Australia
Phone 1719 0
61 414 811 168
Fax 1719 0
61 2 9729 2277
Email 1719 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.