Trial registered on ANZCTR


Trial ID
ACTRN12608000457347
Ethics application status
Approved
Date submitted
12/08/2008
Date registered
15/09/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of a novel, non-robotic intervention to train reaching post stroke
Scientific title
To investigate in stroke survivors undergoing inpatient rehabilitation, the degree of recovery of upper limb motor function that accrues from (A) usual care vs. (B) a non-robotic device (SMART Arm) alone + usual care vs. (C) SMART Arm with triggered electrical stimulation + usual care.
Secondary ID [1] 677 0
Nil
Universal Trial Number (UTN)
Trial acronym
SMART arm
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 3539 0
Condition category
Condition code
Neurological 3694 3694 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group 1 - will undergo 30mins of SMART arm training + 30mins of usual care, 5 times per week, for 4 weeks. SMART arm training will involve the patient performing repetitive, incremental goal-oriented reaching tasks in sitting. Participants will be instructed to push along a linear slide to achieve full range elbow extension at a comfortable speed while receiving real-time visual feedback of performance. Each participant will perform consecutive movement trials for 30 minutes per session. Usual care will involve occupational therapy and physiotherapy intervention aimed to improve function and reduce impairments, performed by their treating therapist. It is likely to incorporate task-oriented activities with manual assistance given if the participant is unable to perform independently.
Intervention group 2 - will undergo 30mins of SMART arm training with triggered electrical stimulation + 30mins of usual care, 5 times per week, for 4 weeks. In this group, the SMART arm reaching tasks will be performed whilst electrical stimulation of triceps is provided concurrently.
Intervention code [1] 3251 0
Rehabilitation
Comparator / control treatment
Control group - will undergo 60mins total of usual care from occupational and physiotherapy combined for the upper limb.
Control group
Active

Outcomes
Primary outcome [1] 4600 0
Motor Assessment Scale item 6 (upper arm function).
Timepoint [1] 4600 0
Measured at baseline, 1 month, 6 months and 12 months.
Secondary outcome [1] 7760 0
Distance reached
Timepoint [1] 7760 0
Measured at baseline, 1 month, 6 months and 12 months.
Secondary outcome [2] 7762 0
Force during reaching, as measured with a strain gauge
Timepoint [2] 7762 0
Measured at baseline, 1 month, 6 months and 12 months.
Secondary outcome [3] 7763 0
The Motor Assessment Scale items 7 and 8. These items assess upper arm function and hand activities.
Timepoint [3] 7763 0
Measured at baseline, 1 month, 6 months and 12 months.
Secondary outcome [4] 7764 0
The Stroke Impact Scale. This measures how the stroke has impacted on health and life.
Timepoint [4] 7764 0
Measured at baseline, 1 month, 6 months and 12 months.

Eligibility
Key inclusion criteria
Individuals will be included if they: have a diagnosis of first ever stroke which occurred within 3mths of the initial test date, be unable to independently perform a standardised reaching task, and be admitted to the Princess Alexandra Hospital (PAH) or QEII hospitals, Brisbane Australia.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be excluded if they have co-morbidities relating to the upper extremity that limit function, such as arthritis, brain injury, Parkinson disease or are unable to tolerate stimulation (e.g. due to hypersensitivity or a skin condition); if they are medically unstable; or are unable to understand the instructions or provide informed consent.

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)
Potential participants will be identified by physiotherapy or occupational therapy staff who will approach patients to inform them of the trial if the treating medical officer is in agreement. Trial staff with then provide trial information sheets and answer queries. Allocation will be concealed through the use of numbered, opaque sealed envelopes and will be maintained at a central location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by functional level (MAS-6 on admission) and will be performed offsite by an independent person using a computer generated random number sequence. Random permuted blocks will be used to ensure that the three groups have equal numbers after every block of participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
1/02/2010
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
75
Actual sample size
Recruitment status
Recruiting
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3722 0
Government body
Name [1] 3722 0
National Health and Medical Research Council
Address [1] 3722 0
National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601
Country [1] 3722 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Division of Physiotherapy,
School of Health & Rehabilitation Sciences
Building 84A, Services Rd,
The University of Queensland St Lucia, Qld, 4072
Country
Australia
Secondary sponsor category [1] 3338 0
None
Name [1] 3338 0
Address [1] 3338 0
Country [1] 3338 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5773 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 5773 0
Ground Floor, Cumbrae-Stewart Building (72)
Research Road
The University of Queensland St Lucia, Qld, 4072
Ethics committee country [1] 5773 0
Australia
Date submitted for ethics approval [1] 5773 0
Approval date [1] 5773 0
14/12/2007
Ethics approval number [1] 5773 0
2007001628
Ethics committee name [2] 5774 0
Princess Alexandra Hospital Medical Research Committee
Ethics committee address [2] 5774 0
Centres for Health Research Level 2, Building 35, Princess Alexandra Hospital Ipswich Rd Woolloongabba, Qld, 4102
Ethics committee country [2] 5774 0
Australia
Date submitted for ethics approval [2] 5774 0
Approval date [2] 5774 0
20/03/2008
Ethics approval number [2] 5774 0
2008/046

Summary
Brief summary
Up to 50% of stroke survivors are left with upper limb disability that limits their daily activities. Several studies have established that recovery of function post stroke is maximised by active, repetitive use of the involved limb in task oriented training programs. Unfortunately for many stroke
survivors, the degree of hemiparesis (or paralysis) is so severe that they are unable to generate enough strength to be involved in exercise training. To address this, a low cost, non-robotic training device (The SMART Arm) was developed by the investigators to provide a smooth and guided track to make reaching easier in people with severe weakness. Using the device with and without triggered electrical stimulation has led to improvements in function and strength in chronic stroke survivors. The current study aims to investigate the ability of the SMART arm with and without triggered stimulation to improve arm impairment, activity and participation in acute stroke survivors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28830 0
Address 28830 0
Country 28830 0
Phone 28830 0
Fax 28830 0
Email 28830 0
Contact person for public queries
Name 11987 0
Dr Sandra Brauer
Address 11987 0
Division of Physiotherapy
School of Health & Rehabilitation Sciences
Building 84A, Services Rd
The University of Queensland
St Lucia, Qld, 4072
Country 11987 0
Australia
Phone 11987 0
07 3365 2317
Fax 11987 0
07 3365 1622
Email 11987 0
s.brauer@uq.edu.au
Contact person for scientific queries
Name 2915 0
Dr Sandra Brauer
Address 2915 0
School of Health & Rehabilitation Sciences
Building 84A, Services Rd
The University of Queensland
St Lucia, Qld, 4072
Country 2915 0
Australia
Phone 2915 0
07 3365 2317
Fax 2915 0
07 3365 1622
Email 2915 0
s.brauer@uq.edu.au