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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01086930
Registration number
NCT01086930
Ethics application status
Date submitted
12/03/2010
Date registered
15/03/2010
Titles & IDs
Public title
Early Intensive Hand Rehabilitation After Spinal Cord Injury
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Scientific title
SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury
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Secondary ID [1]
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SCIPA Hands-On
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Universal Trial Number (UTN)
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Trial acronym
SCIPAHandsOn
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Injuries and Accidents
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Other injuries and accidents
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Neurological
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Other neurological disorders
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - ReJoyce Workstation
Other interventions - Standard Care
Experimental: Intervention Group - In addition to standard care participants in Group A will receive:
• One hour of extra hand training five times per week for 8 weeks using the ReJoyce Workstation.
The training will be supervised by a therapist and provided to the target hand. The hand exercises will be incorporated into computer games and will involve the following tasks using different manipulanda:
* reaching
* grasping
* manipulating
* pulling
* rotating
* releasing
Other: Standard Care Group - Participants in the control group will not receive any training on the instrumented workstation or electrical stimulation to the hand or upper limb. They will however continue to receive standard care as well as three 15-minute specific hand activity sessions per week specifically devoted to the practice of hand activities in a one-to-one format with a therapist (as per the treatment received by the experimental group).
Treatment: Devices: ReJoyce Workstation
The device has two parts. A muscle-stimulator garment that incorporates a wireless-triggered stimulator cuff and an earpiece, similar to a hearing aid, that sends a radio signal to the stimulator cuff. As well as a specialised workstation known as ReJoyce, which connects to a standard computer via a USB port. This work station will allow the user to play specialised computer games focusing on hand function. The stimulator system and the ReJoyce workstation were developed by Professor Arthur Prochazka, University of Alberta, Canada and has been approved by the Canadian Standards Association.
Other interventions: Standard Care
All participants will continue to receive the same standard care for the hand and upper limb as typically provided by their rehabilitation units.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Modified Action Research Arm Test
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Assessment method [1]
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A standardized measure of unilateral hand and upper limb function
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Timepoint [1]
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8 weeks and 26 weeks
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Secondary outcome [1]
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Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension
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Assessment method [1]
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Summed strength score of 10 upper limb muscles
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Timepoint [1]
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8 weeks and 26 weeks
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Secondary outcome [2]
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Sensory Score on ISNCSCI
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Assessment method [2]
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Scores for light touch and pinprick tested in dermatomes of the upper limb
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Timepoint [2]
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8 weeks and 26 weeks
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Secondary outcome [3]
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AsTex Sensory Test
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Assessment method [3]
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A measure of texture discrimination in the fingertips
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Timepoint [3]
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8 weeks and 26 weeks
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Secondary outcome [4]
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AuSpinal Test
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Assessment method [4]
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A test of hand function
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Timepoint [4]
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8 weeks and 26 weeks
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Secondary outcome [5]
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Capabilities of Upper Extremity
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Assessment method [5]
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A questionnaire about upper limb function
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Timepoint [5]
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8 weeks and 26 weeks
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Secondary outcome [6]
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Assessment of Quality of Life (AQoL)
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Assessment method [6]
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A questionnaire to assess quality of life
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Timepoint [6]
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8 weeks and 26 weeks
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Secondary outcome [7]
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Health Utilities Index Mark 3
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Assessment method [7]
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A questionnaire to assess quality of life, but includes a domain on hand function
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Timepoint [7]
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8 weeks and 24 weeks
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Secondary outcome [8]
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Self-care subscale of the Spinal Cord Independence Measure
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Assessment method [8]
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A questionnaire about independence in self-care
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Timepoint [8]
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8 weeks and 24 weeks
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Secondary outcome [9]
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Goal Attainment Scale
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Assessment method [9]
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An assessment of whether a participant achieved pre-set goals
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Timepoint [9]
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8 weeks
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Secondary outcome [10]
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Participant Perception of Treatment Effectiveness
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Assessment method [10]
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Self resport of treatment effectiveness
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Timepoint [10]
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8 weeks
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Eligibility
Key inclusion criteria
Patients will be included if they:
1. have sustained a SCI within the preceding 6 months from time of consent
2. are currently receiving inpatient rehabilitation through one of the study sites
3. will remain in hospital for 12 weeks after initial screening as part of their standard medical/rehabilitation care
4. are 16 years of age or older and able to provide informed consent
5. 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)
6. can actively flex their shoulder/s to 60 degrees
7. have reduced ability to grasp using their hands
8. are able to tolerate sufficient FES to enable one hand to grasp and release
9. have the potential to benefit from FES and ReJoyce according to the judgment of the treating therapist
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Minimum age
16
Years
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Maximum age
No limit
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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
Patients will not be included if they:
1. have any other type of neurological injury affecting the target hand (e.g. brachial plexus or peripheral nerve injuries)
2. have had recent trauma or surgery to the target hand or upper limb within the last 12 months
3. have had amputation of any digits on the target hand
4. are not able to sit out of bed each day for at least 2 hours over three consecutive days
5. have extensive fixed contractures in the upper limb of the target hand preventing use of the ReJoyce
6. have severe spasticity in the target hand or upper limb preventing use of the ReJoyce
7. are unable to attend the 6-month and 1-year follow-up assessments at their treating spinal unit
8. are likely to undergo hand surgery in the target hand in the next year
9. might experience autonomic dysreflexia and/or hypotension in response to electrical stimulation
10. have any contraindications to FES, such as cardiac pacemaker, epilepsy, forearm fracture or pregnancy
11. have intracranial metal implants
12. have impaired vision and/or are unable to view a computer screen
13. 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2009
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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
1/09/2015
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Sample size
Target
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Accrual to date
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Final
70
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Spinal Unit, Prince of Wales Hospital - Randwick
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Recruitment hospital [2]
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Royal Rehabilitation Centre Sydney - Sydney
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Recruitment hospital [3]
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Queensland Spinal Cord Injury Service, Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [4]
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South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre - Northfield
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Recruitment hospital [5]
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Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre - Kew
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Recruitment hospital [6]
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Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital - Shenton Park
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Recruitment postcode(s) [1]
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- Randwick
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Recruitment postcode(s) [2]
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- Sydney
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Recruitment postcode(s) [3]
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- Woolloongabba
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Recruitment postcode(s) [4]
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- Northfield
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Recruitment postcode(s) [5]
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3101 - Kew
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Recruitment postcode(s) [6]
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- Shenton Park
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Austin Hospital, Melbourne Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Hampstead Rehabilitation Centre Adelaide
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Shenton Park Rehabilitation Centre Perth
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Princess Alexandra Hospital, Brisbane, Australia
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Royal Rehabilitation Centre Sydney
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Address [5]
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Country [5]
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Other collaborator category [6]
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Government body
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Name [6]
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Prince of Wales Hospital, Sydney
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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Burwood Hospital, Christchurch, New Zealand
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Address [7]
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Country [7]
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Ethics approval
Ethics application status
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Summary
Brief summary
Loss of hand function is one of the most devastating consequences of tetraplegia because of the severe impact on activities of daily living (ADL) and the resultant dependency on others. This multi-centre study in 78 participants will measure whether additional hand therapy provided via an electrical stimulator glove and specialised computer workstation improves hand function in people with tetraplegia.
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Trial website
https://clinicaltrials.gov/study/NCT01086930
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Trial related presentations / publications
Harvey LA, 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. doi: 10.1186/1745-6215-12-14. Harvey LA, Dunlop SA, Churilov L, Galea MP; Spinal Cord Injury Physical Activity (SCIPA) Hands On Trial Collaborators. 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. J Physiother. 2016 Apr;62(2):88-95. doi: 10.1016/j.jphys.2016.02.013. Epub 2016 Mar 19. Harvey LA, Dunlop SA, Churilov L, Galea MP; Spinal Cord Injury Physical Activity (SCIPA) Hands On Trial Collaborators. 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. J Physiother. 2017 Oct;63(4):197-204. doi: 10.1016/j.jphys.2017.08.005. Epub 2017 Sep 29.
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Public notes
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Contacts
Principal investigator
Name
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Lisa Harvey
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Address
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University of Sydney
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
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
Data will only be provided in aggregate. No individual data will be released, as per the ethics approval.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Harvey LA, Dunlop SA, Churilov L, Galea MP; Spinal...
[
More Details
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Results not provided in
https://clinicaltrials.gov/study/NCT01086930