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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01086930




Registration number
NCT01086930
Ethics application status
Date submitted
12/03/2010
Date registered
15/03/2010
Date last updated
5/08/2011

Titles & IDs
Public title
SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury
Scientific title
SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury
Secondary ID [1] 0 0
SCIPA Hands-On
Universal Trial Number (UTN)
Trial acronym
SCIPA Hands-On
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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
The training will be supervised by a therapist and provided to the target hand. It will consist of FES-assisted hand exercises on an instrumented exercise workstation (ReJoyce). 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. The first part is a muscle-stimulator garment that incorporates a wireless-triggered stimulator cuff, word 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 is turn stimulates the hand to open or close, allowing patients to grasp and release objects. The second part of the device is 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. The device is currently being used in a study conducted through the University of Alberta.

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. This will be provided as part of regular physiotherapy, vocational, recreational and occupational therapy and provided by participants' usual treating therapists. These therapists will not be involved in administering the study-specific interventions.

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the relative effectiveness of an intensive task-specific motor training program and standard rehabilitation compared with standard rehabilitation alone for improving hand function and clinical outcomes in people with recent tetraplegia.
Timepoint [1] 0 0
8 weeks

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
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Spinal Unit, Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Royal Rehabilitation Centre Sydney - Sydney
Recruitment hospital [3] 0 0
Queensland Spinal Cord Injury Service, Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre - Northfield
Recruitment hospital [5] 0 0
Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre - Kew
Recruitment hospital [6] 0 0
Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital - Shenton Park
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment postcode(s) [4] 0 0
- Northfield
Recruitment postcode(s) [5] 0 0
3101 - Kew
Recruitment postcode(s) [6] 0 0
- Shenton Park
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Victorian Neurotrauma Initiative
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Lifetime Care and Support Authority (NSW)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The University of Western Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01086930
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lisa Harvey
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lisa Harvey
Address 0 0
Country 0 0
Phone 0 0
+61 2 9809 9099
Fax 0 0
Email 0 0
lisa.harvey@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01086930