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Trial registered on ANZCTR


Registration number
ACTRN12609000695202
Ethics application status
Approved
Date submitted
22/07/2009
Date registered
12/08/2009
Date last updated
16/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury
Scientific title
Early Intensive Hand Rehabilitation After Spinal Cord Injury: Effect of a novel muscle-stimulator device versus standard treatment on hand function in participants with spinal cord injury.
Secondary ID [1] 289478 0
Nil
Universal Trial Number (UTN)
Trial acronym
SCIPA Hands-On
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 237332 0
Condition category
Condition code
Injuries and Accidents 239650 239650 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 239651 239651 0 0
Other physical medicine / rehabilitation
Neurological 239652 239652 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The device is a muscle-stimulator garment that incorporates a wireless-triggered stimulator cuff which emitts electrical impulses known as Functional Electrical Stimulation (FES). The garment is worn on the forearm and triggered when the user clicks his/her teeth. The tooth clicks (vibrations) are detected by an earpiece, similar to a hearing aid, that sends a radio signal to the stimulator cuff. This in turn stimulates the hand to open or close, allowing the patients to grasp and release objects. The garmet will be used five times a week for up to one hour each session, over the 8 week intervention period. Patients will continue to receive standard care while participating in the study. The study intervention will be in addition to standard care.

The stimulator system has been approved by the Canadian Standards Association. The device is not yet available in Australia, but will be obtained from the inventor, Professor Arthur Prochazka, University of Alberta, Canada when funding for the study becomes available.
Intervention code [1] 236994 0
Treatment: Devices
Intervention code [2] 236995 0
Rehabilitation
Comparator / control treatment
The comparator group for this study will be standard care already provided for hand function to patients with a spinal cord injury. Standard care will provided as per the individual patients standard treatment plan for their injury.
Control group
Active

Outcomes
Primary outcome [1] 238430 0
The primary endpoint is the Action Research Arm Test (ARAT) score at Week 8 (Post-
Intervention Assessment)
Timepoint [1] 238430 0
Following 8 weeks of treatment.
Secondary outcome [1] 244927 0
ARAT score at 6 and 12 months.
Timepoint [1] 244927 0
6months and 12months post randomisation
Secondary outcome [2] 244928 0
Goal Attainment Scale (GAS) at Week 8 (Post Protocol Intervention Assessment), and at 6 and 12 months.
Timepoint [2] 244928 0
Following 8 weeks of treatment, 6 and 12 months post randomisation.
Secondary outcome [3] 244929 0
Spinal Cord Independence Measure (SCIM) - Self Care scores at Week 8 (Post-Intervention
Assessment), and at 6 and 12 months.
Timepoint [3] 244929 0
Following 8 weeks of treatment, 6 and 12 months post randomisation.
Secondary outcome [4] 244930 0
Quality of life outcomes, Assessment of Quality of Life-8 (AQoL-8) and Health Utilities Index Mark 3(HUI3 at Week 8 (Post-Intervention Assessment), and at 6 and 12 months.
Timepoint [4] 244930 0
Following 8 weeks of treatment, 6 and 12 months post randomisation.
Secondary outcome [5] 244931 0
Upper limb American Spinal Inury Association (ASIA) sensory scores at Week 8 (Post-Intervention
Assessment), and at 6 and 12 months
Timepoint [5] 244931 0
Following 8 weeks of treatment, 6 and 12 months post randomisation.
Secondary outcome [6] 257184 0
AuSpinal assessment of hnd function at Week 8 (Post Protocol Intervention Assessment), and at 6 and 12 months.
Timepoint [6] 257184 0
Following 8 weeks of treatment, 6 and 12 months post randomisation.
Secondary outcome [7] 257185 0
Texture discrimination capabilities of the fingertips measured by AsTex Sensory Test at Week 8 (Post Protocol Intervention Assessment), and at 6 and 12 months.
Timepoint [7] 257185 0
Following 8 weeks of treatment, 6 and 12 months post randomisation.
Secondary outcome [8] 257186 0
The Capabilities of Upper Extremity (CUE), at Week 8 (Post Protocol Intervention Assessment), and at 6 and 12 months.
Timepoint [8] 257186 0
Following 8 weeks of treatment, 6 and 12 months post randomisation.
Secondary outcome [9] 257187 0
Summed Upper Limb Strength
component of Graded and Redefined Assessment of Strength Sensibility and Prehension (GRASSP), at Week 8 (PostProtocolIntervention Assessment), and at 6 and 12 months.
Timepoint [9] 257187 0
Following 8 weeks of treatment, 6 and 12 months post randomisation.
Secondary outcome [10] 257188 0
Participant Perception of Treatment Effectiveness (PPTE) at Week 8 (Post Protocol Intervention Assessment), and at 6 and 12 months.
Timepoint [10] 257188 0
Following 8 weeks of treatment, 6 and 12 months post randomisation.

Eligibility
Key inclusion criteria
* have sustained a Spinal Cord Injury (SCI)within the preceding 6 months from time of consent
* are currently receiving inpatient rehabilitation through one of the study sites
* will remain in hospital for 12 weeks after initial screening
* are 16 years of age or older and able to provide informed consent
* have a motor complete or incomplete spinal cord injury at the neurological level of C2 to T1 (as per the International Standardised Neurological Assessment for SCI)
* can actively flex their target shoulder to 60 degrees
* have reduced ability to grasp using the target hand
* are able to tolerate sufficient Functional Electrical Stimulation (FES) to enable one hand to grasp and release
* have the potential to benefit from FES and ReJoyce according to the judgment of the treating therapist
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* have any other type of neurological injury affecting the target hand (e.g. brachial plexus or peripheral nerve injuries)
* have had recent trauma or surgery to the target hand or upper limb within the last 12 months
* have had amputation of any digits on the target hand
* are not able to sit out of bed each day for at least 2 hours over three consecutive days
* have extensive fixed contractures in the upper limb of the target hand preventing use of the ReJoyce
* have severe spasticity in the target hand or upper limb preventing use of the ReJoyce
* are unable to attend the 6-month and 1-year follow-up assessments at their treating spinal unit
* are likely to undergo hand surgery in the target hand in the next year
* are likely to experience autonomic dysreflexia and/or hypotension in response to electrical stimulation
* have any contraindications to FES such as cardiac pacemaker, epilepsy, forearm fracture or pregnancy
* have intracranial metal implants
* have impaired vision and/or are unable to view a computer screen
* have any other serious medical condition including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant’s ability to cooperate or in the opinion of the study investigator would prevent the participant from adhering to the Protocol.

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)
Partiticpants will participate in a screening visit and a baseline visit prior to randomisation.
Eligible participants will be randomised to one of two groups, namely:
1. Group A - Experimental group: FES-assisted hand exercise plus standard care,
2. Group B - Control group: standard care alone.

Randomisation will be stratified by site and baseline Action Research Arm Test (ARAT) score (<=21 versus >21) and co-ordinated by a central randomisation unit. Upon completion of all screening and baseline assessments and suitability checks, a participant eligibility checklist will be completed by the Site Coordinator and signed by the Principal Investigator. This checklist will be sent to the central randomisation unit who will notify the Site Coordinator of treatment assignment in writing. This will not be disclosed to the Blinded Assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 1979 0
1680
Recruitment postcode(s) [2] 1980 0
5000
Recruitment postcode(s) [3] 1981 0
3101
Recruitment postcode(s) [4] 1982 0
2036
Recruitment postcode(s) [5] 1983 0
6001
Recruitment postcode(s) [6] 1984 0
4102
Recruitment outside Australia
Country [1] 1914 0
New Zealand
State/province [1] 1914 0
Auckland

Funding & Sponsors
Funding source category [1] 237381 0
Other Collaborative groups
Name [1] 237381 0
Victorian Neurotrama Initiative
Address [1] 237381 0
Level 6, 60 Brougham Street
Geelong, VIC 3220
Country [1] 237381 0
Australia
Funding source category [2] 293837 0
Government body
Name [2] 293837 0
Lifetime Care and Support Authority
Address [2] 293837 0
Level 24, 580 George St
Sydney NSW 2000

Country [2] 293837 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Parkville, VIC, 3101
Country
Australia
Secondary sponsor category [1] 236881 0
None
Name [1] 236881 0
Address [1] 236881 0
Country [1] 236881 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239512 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 239512 0
Level 3, Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000
Ethics committee country [1] 239512 0
Australia
Date submitted for ethics approval [1] 239512 0
27/08/2009
Approval date [1] 239512 0
18/11/2009
Ethics approval number [1] 239512 0
Ethics committee name [2] 239513 0
Multi-region Ethics Committee
Ethics committee address [2] 239513 0
P.O. Box 5013
Wellington, 5016
Ethics committee country [2] 239513 0
New Zealand
Date submitted for ethics approval [2] 239513 0
31/07/2009
Approval date [2] 239513 0
23/10/2009
Ethics approval number [2] 239513 0
Ethics committee name [3] 239582 0
Austin Health Human Research Ethics Committee
Ethics committee address [3] 239582 0
Austin Health
145 Studley Road
Heidelberg, VIC, 3084
Ethics committee country [3] 239582 0
Australia
Date submitted for ethics approval [3] 239582 0
03/08/2009
Approval date [3] 239582 0
12/10/2009
Ethics approval number [3] 239582 0
Ethics committee name [4] 258470 0
Royal Perth Hospital Ethics Committee
Ethics committee address [4] 258470 0
Room 4112, Level 4, Kirkman House, Perth, 6000, WA
Ethics committee country [4] 258470 0
Australia
Date submitted for ethics approval [4] 258470 0
26/08/2009
Approval date [4] 258470 0
04/12/2009
Ethics approval number [4] 258470 0
2009/083

Summary
Brief summary
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with tetraplegia (a spinal cord injury). A total of 78 participants will be randomised into two groups; 1. the experimental group and 2. the control group. The control group will receive standard rehabilitation care, while the experimental group will receive standard rehabilitation care plus the study treatment which involves one hour of extra hand training using a specialised glove and computer workstation, 5 times a week.
The primary objective is to determine if the study treatment is more effective than standard rehabilitation care alone in participants with tetraplegia. The secondary objectives involve collecting exploratory data to support primary objective, including an economic analysis.
Total study duration is 3 years, including an 18 month recruitment period, an 8-week treatment period followed by 6 month and 12 month follow up assessments.
The study treatment will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy/occupational therapy assessments which involve grasping and releasing different objects and performing everyday tasks as well as quality of life questionnaires.

Functional electrical stimulation combined with task-specific training provided in addition to standard care is more effective in improving hand function than standard care alone.
Trial website
Trial related presentations / publications
Harvey LA1, Dunlop SA, Churilov L, Hsueh YS, Galea MP. Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial. Trials. (2011) Jan 17;12:14.

LA Harvey, SA Dunlop, L Churilov, MP Galea, Early intensive hand rehabilitation is not more effective than usual care plus one-to-one hand therapy in people with sub-acute spinal cord injury (‘Hands On’): a randomised trial. JPhysiotherapy, (2016) Vol 62, Issue 2, 88–95


Public notes

Contacts
Principal investigator
Name 29947 0
A/Prof Lisa Harvey
Address 29947 0
Rehabilitation Studies Unit
Sydney Medical School/Northern
THE UNIVERSITY OF SYDNEY
PO Box 6
RYDE, NSW, 2112
Country 29947 0
Australia
Phone 29947 0
+61 2 9809 9099
Fax 29947 0
Email 29947 0
lisa.harvey@sydney.edu.au
Contact person for public queries
Name 13194 0
Mrs Melanie Hurley
Address 13194 0
Neuroscience Trials Australia (SCIPA / University of Melbourne)
(a business unit within the Florey Institute of Neuroscience and Mental Health) Melbourne Brain Centre - Austin Campus
245 Burgundy Street
Heidelberg VIC 3084
Country 13194 0
Australia
Phone 13194 0
+61 3 9035 7235
Fax 13194 0
+61 3 9496 2881
Email 13194 0
mhurley@unimelb.edu.au
Contact person for scientific queries
Name 4122 0
Prof Prof Mary Galea
Address 4122 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Royal Park Campus
34-54 Poplar Road
Parkville, Victoria, 3052
Country 4122 0
Australia
Phone 4122 0
+61 3 8387 2017
Fax 4122 0
No fax
Email 4122 0
m.galea@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary