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Trial registered on ANZCTR
Registration number
ACTRN12618001770257
Ethics application status
Approved
Date submitted
23/10/2018
Date registered
29/10/2018
Date last updated
2/03/2022
Date data sharing statement initially provided
29/10/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Reversing peripheral nerve dysfunction after spinal cord injury
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Scientific title
Reversing peripheral nerve dysfunction using functional electrical stimulation after spinal cord injury
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Secondary ID [1]
296425
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None
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Universal Trial Number (UTN)
U1111-1222-6740
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
spinal cord injury
310150
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Condition category
Condition code
Neurological
308901
308901
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0
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Other neurological disorders
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Injuries and Accidents
308924
308924
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Functional electrical stimulation will be delivered using the ReGrasp device. Surface electrodes are embedded in a cuff worn on the forearm. The stimulator can be operated independently by simple head motions detected by an earpiece containing an accelerometer. The earpiece sends radio frequency signals to the stimulator, advancing it through a 3-state sequence: hand opening, grasp, no stimulation. Typical pulse parameters are: biphasic rectangular wave pulses, frequency 20 to 30 pulses/sec, pulse duration 100 to 200 microseconds, amplitude 25 to 35mA, However, clinicians will be able to adjust values for patient comfort. Participants and their carers will be trained in the use of the ReGrasp, and participants will be asked to use the device for at least one hour daily, 5 days per week for 6 weeks prior to nerve transfer surgery. They will be asked to record their daily use of the ReGrasp in a diary, and adherence will be monitored through weekly phone calls by the therapist to participants, who will also monitor any adverse events. Surgery will occur between 1 and 2 weeks after cessation of the stimulation. This surgery does not form part of the intervention.
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Intervention code [1]
312729
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Treatment: Devices
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Comparator / control treatment
Historical histological data collected in 15 participants with spinal cord injury who underwent nerve transfer surgery between 2013 and 2015. These participants did not have functional electrical stimulation prior to surgery.
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Control group
Historical
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Outcomes
Primary outcome [1]
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Axon/nerve fibre ratio, measured in sections of nerve specimens embedded in Araldite Epon, and stained with Methylene Blue. Sections will be analysed using an Olympus BX60 microscope and x100 oil immersion objective, interfaced with monitor and image analysis software,
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Assessment method [1]
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Timepoint [1]
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At time of surgery
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Secondary outcome [1]
353180
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Presence or absence of fibrillations on needle electromyography (EMG) pre-operatively
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Assessment method [1]
353180
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Timepoint [1]
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Prior to surgery
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Secondary outcome [2]
407071
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Grip and pinch strength, assessed using grip and pinch dynamometers
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Assessment method [2]
407071
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Timepoint [2]
407071
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Baseline, post FES intervention, 12- and 24 months post-surgery
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Secondary outcome [3]
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Action Research Arm Test (ARAT)
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Assessment method [3]
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Timepoint [3]
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Baseline, post-FES intervention, 12- and 24 months post surgery
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Secondary outcome [4]
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Grasp-Release Test (GRT)
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Assessment method [4]
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Timepoint [4]
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Baseline, post-FES intervention, 12- and 24 months post-surgery
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Secondary outcome [5]
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Canadian Occupational Performance Measure (COPM) will measure a participant's perception of their performance and satisfaction.
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Assessment method [5]
407074
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Timepoint [5]
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Baseline, post-FES intervention, 12- and 24 months post surgery
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Secondary outcome [6]
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Daily function assessed by the Spinal Cord Independence Measure (SCIM).
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Assessment method [6]
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Timepoint [6]
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Baseline, post-FES intervention, 12- and 24 months post surgery
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Secondary outcome [7]
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Spinal Cord Injury version of the Multidimensional Pain Inventory
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Assessment method [7]
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Timepoint [7]
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Baseline, post-FES intervention, 12- and 24 monts post-surgery
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Secondary outcome [8]
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Personal Wellbeing Index
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Assessment method [8]
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Timepoint [8]
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Baseline, post-FES intervention, 12- and 24 months post-surgery
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Secondary outcome [9]
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Health Utilities Index, Mark 3 (HUI-3) will be used to measure health status and to conduct a cost-utility analysis..
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Assessment method [9]
407078
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Timepoint [9]
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Baseline, post-FES intervention, 12- and 24 months post-surgery
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Secondary outcome [10]
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Assessment of Quality of Life-4D (AQoL-4)
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Assessment method [10]
407079
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Timepoint [10]
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Baseline, post-FES intervention, 12- and 24 months post-surgery
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Eligibility
Key inclusion criteria
1. Complete or incomplete tetraplegia with C5 – C7 motor neurological level
2. Assessed as suitable for nerve transfer surgery by the surgical and occupational therapy team at the Upper Limb Program Multidisciplinary Clinic at Austin Health
3. Consent to nerve transfer surgery and intra-operative nerve and muscle biopsies after being fully informed about expected outcomes, potential risks, surgical procedure, recovery time, postoperative therapy commitments.
4. Able to comply with therapy protocols pre-operatively
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Accompanying head injury, brachial plexus or peripheral nerve injury at the time of, or preceding the spinal cord injury
2. Any other pre-existing neurological condition
3. Cognitive impairment limiting ability to consent to surgery or comply with postoperative rehabilitation
4. Skeletal or joint injury signifcantly limiting passive range of movement across a joint relevant to the proposed nerve transfer
5. Contraindications to functional electrical stimulation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
For the primary analysis, the difference in the ratio of axon CSA/nerve fibre CSA in stimulated and non-stimulated nerves will be examined using a t-test if the data are normally distributed, and non-parametric tests if assumptions of normality are not met. Secondary analyses will examine differences on all other histological features between stimulated and non-stimulated nerves and healthy control specimens, including the length of the node of Ranvier, as well as changes in hand function scores before and after the 6 weeks of pre-operative FES, and on changes in quality of life, pain and wellbeing between baseline and 24 months.
Cost-utility analysis: The two treatment groups will be compared in terms of their costs and quality-adjusted life years (QALYs) estimated by HUI-3 to estimate the cost-utility of FES and nerve transfer surgery (NTS) compared to NTS alone. Analysis will be undertaken on an intention-to-treat basis. Between-group cost and QALY differences will be presented as a point estimate incremental cost utility ratio (ICUR) to summarise the estimated additional cost per additional QALY gained from adding the 6-week FES program prior to upper limb NTS compared to NTS alone.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
3/03/2020
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Actual
22/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
15
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Accrual to date
4
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
12241
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
24427
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
301009
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University
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Name [1]
301009
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University of Melbourne
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Address [1]
301009
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Grattan Street,
Parkville, Victoria 3084
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Country [1]
301009
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Australia
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Funding source category [2]
301027
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Hospital
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Name [2]
301027
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Austin Health
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Address [2]
301027
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145 Studley Road,
Heidelberg, Victoria 3084
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Country [2]
301027
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Australia
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Funding source category [3]
310912
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Charities/Societies/Foundations
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Name [3]
310912
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Wings For Life
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Address [3]
310912
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Fürstenallee 4, 5020 Salzburg
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Country [3]
310912
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Austria
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Funding source category [4]
310913
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Government body
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Name [4]
310913
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Transport Accident Commission, Victoria
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Address [4]
310913
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60 Brougham St, Geelong VIC 3220
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Country [4]
310913
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
145 Studley Road,
Heidelberg, Victoria, 3084
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Country
Australia
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Secondary sponsor category [1]
300598
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None
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Name [1]
300598
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Address [1]
300598
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Country [1]
300598
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301767
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
301767
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Austin Health,
145 Studley Road,
Heidelberg, Victoria, 3084
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Ethics committee country [1]
301767
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Australia
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Date submitted for ethics approval [1]
301767
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31/10/2018
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Approval date [1]
301767
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30/07/2019
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Ethics approval number [1]
301767
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Summary
Brief summary
This study will specifically investigate whether functional electrical stimulation (FES) reverses myelin abnormalities in peripheral nerves of people with spinal cord injury. Participants who are scheduled to undergo nerve transfer surgery will be asked to undertake a program of FES using the ReGrasp device (Rehabtronics Inc, Edmonton Canada) for at least one hour dail, 5 days per week for 6 weeks prior to the surgery. This device enables a person to close and open the hand and can be operated independently by simple head motions detected by an earpiece. Biopsies of the relevant nerves and muscles will be obtained during the surgery, and these will be processed, analysed and compared with those obtained from previous nerve transfer surgery participants (historical controls). The primary outcome measure is the axon/nerve fibre ratio. Secondary outcomes include clinical assessments of hand function, independence, pain, well-being and quality of life, with participants being followed up for 24 months post-surgery. A cost-utility analysis will also be conducted.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Mary Galea
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Address
88030
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Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Level 4, Clinical Sciences Building
Royal Melbourne Hospital
Royal Parade
Parkville, Victoria 3052
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Country
88030
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Australia
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Phone
88030
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+61418173521
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Fax
88030
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Email
88030
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[email protected]
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Contact person for public queries
Name
88031
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Prof Mary Galea
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Address
88031
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Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Level 4, Clinical Sciences Building
Royal Melbourne Hospital
Royal Parade
Parkville, Victoria 3052
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Country
88031
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Australia
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Phone
88031
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+61418173521
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Fax
88031
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Email
88031
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[email protected]
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Contact person for scientific queries
Name
88032
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Prof Mary Galea
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Address
88032
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Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Level 4, Clinical Sciences Building
Royal Melbourne Hospital
Royal Parade
Parkville, Victoria 3052
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Country
88032
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Australia
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Phone
88032
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+61418173521
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Fax
88032
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Email
88032
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
It has not yet been decided whether individual participant data will be made available, since this study involves a very small group of participants.
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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.
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