Trial from ANZCTR


Trial ID ACTRN12608000457347
Trial Status: Registered
Date Submitted: 12/08/2008
Date Registered: 15/09/2008
Prospectively registered

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Public title The efficacy of a novel, non-robotic intervention to train reaching post stroke
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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.
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Secondary ID [1] 677 0
Nil
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UTN
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Trial acronym SMART arm
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Health condition(s) or problem(s) studied:
Stroke 3539 0
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Condition category: Condition code:
Neurological Other neurological disorders
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3694 3694 0 0

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Descriptions 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.
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Intervention Code:
Rehabilitation 3251 0
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Comparator / control treatment Control group - will undergo 60mins total of usual care from occupational and physiotherapy combined for the upper limb.
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Control group Active
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Primary Outcome: Motor Assessment Scale item 6 (upper arm function). 4600 0
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Timepoint: Measured at baseline, 1 month, 6 months and 12 months. 4600 0
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Secondary Outcome: Distance reached 7760 0
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Timepoint: Measured at baseline, 1 month, 6 months and 12 months. 7760 0
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Secondary Outcome: Force during reaching, as measured with a strain gauge 7762 0
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Timepoint: Measured at baseline, 1 month, 6 months and 12 months. 7762 0
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Secondary Outcome: The Motor Assessment Scale items 7 and 8. These items assess upper arm function and hand activities. 7763 0
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Timepoint: Measured at baseline, 1 month, 6 months and 12 months. 7763 0
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Secondary Outcome: The Stroke Impact Scale. This measures how the stroke has impacted on health and life. 7764 0
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Timepoint: Measured at baseline, 1 month, 6 months and 12 months. 7764 0
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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.
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/02/2010
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 75
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Recruitment status Recruiting
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Government body 3722 0
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Name: National Health and Medical Research Council 3722 0
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Address: National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601 3722 0
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Country: Australia 3722 0
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Primary Sponsor University
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Name: The University of Queensland
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Address: Division of Physiotherapy,
School of Health & Rehabilitation Sciences
Building 84A, Services Rd,
The University of Queensland St Lucia, Qld, 4072
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Country: Australia
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Secondary Sponsor: None 3338 0
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Name: 3338 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: The University of Queensland Medical Research Ethics Committee 5773 0
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Address: Ground Floor, Cumbrae-Stewart Building (72)
Research Road
The University of Queensland St Lucia, Qld, 4072
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Country: Australia 5773 0
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Approval Date: 14/12/2007 5773 0
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Submitted Date: 5773 0
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HREC: 2007001628 5773 0
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Ethics Committee name: Princess Alexandra Hospital Medical Research Committee 5774 0
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Address: Centres for Health Research Level 2, Building 35, Princess Alexandra Hospital Ipswich Rd Woolloongabba, Qld, 4102 5774 0
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Country: Australia 5774 0
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Approval Date: 20/03/2008 5774 0
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Submitted Date: 5774 0
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HREC: 2008/046 5774 0
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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.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Sandra Brauer
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Address: Division of Physiotherapy School of Health & Rehabilitation Sciences Building 84A, Services Rd The University of Queensland St Lucia, Qld, 4072
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Country: Australia
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Tel: 07 3365 2317
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Fax: 07 3365 1622
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Email: s.brauer@uq.edu.au
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Contact person for scientific queries
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Name: Dr Sandra Brauer
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Address: School of Health & Rehabilitation Sciences Building 84A, Services Rd The University of Queensland St Lucia, Qld, 4072
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Country: Australia
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Fax: 07 3365 1622
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Email: s.brauer@uq.edu.au
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Contact person responsible for updating information
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Name: Dr Sandra Brauer
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Address: School of Health & Rehabilitation Sciences Building 84A, Services Rd The University of Queensland St Lucia, Qld, 4072
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Country: Australia
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Tel: 07 3365 2317
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Fax: 07 3365 1622
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Email: s.brauer@uq.edu.au
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Addition Cancer fields
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