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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
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
SCIPAHandsOn
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 0 0
Condition category
Condition code
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
Skin 0 0 0 0
Other skin conditions

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 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.
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
Modified Action Research Arm Test
Timepoint [1] 0 0
8 weeks and 26 weeks
Secondary outcome [1] 0 0
Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension
Timepoint [1] 0 0
8 weeks and 26 weeks
Secondary outcome [2] 0 0
Sensory Score on ISNCSCI
Timepoint [2] 0 0
8 weeks and 26 weeks
Secondary outcome [3] 0 0
AsTex Sensory Test
Timepoint [3] 0 0
8 weeks and 26 weeks
Secondary outcome [4] 0 0
AuSpinal Test
Timepoint [4] 0 0
8 weeks and 26 weeks
Secondary outcome [5] 0 0
Capabilities of Upper Extremity
Timepoint [5] 0 0
8 weeks and 26 weeks
Secondary outcome [6] 0 0
Assessment of Quality of Life (AQoL)
Timepoint [6] 0 0
8 weeks and 26 weeks
Secondary outcome [7] 0 0
Health Utilities Index Mark 3
Timepoint [7] 0 0
8 weeks and 24 weeks
Secondary outcome [8] 0 0
Self-care subscale of the Spinal Cord Independence Measure
Timepoint [8] 0 0
8 weeks and 24 weeks
Secondary outcome [9] 0 0
Goal Attainment Scale
Timepoint [9] 0 0
8 weeks
Secondary outcome [10] 0 0
Participant Perception of Treatment Effectiveness
Timepoint [10] 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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
70
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
Austin Hospital, Melbourne Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Hampstead Rehabilitation Centre Adelaide
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Shenton Park Rehabilitation Centre Perth
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Royal Rehabilitation Centre Sydney
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Government body
Name [6] 0 0
Prince of Wales Hospital, Sydney
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Burwood Hospital, Christchurch, New Zealand
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will only be provided in aggregate. No individual data will be released, as per the ethics approval.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Harvey LA, Dunlop SA, Churilov L, Galea MP; Spinal... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT01086930