SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury (SCIPA Hands-On)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Melbourne.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Victorian Neurotrauma Initiative
Lifetime Care and Support Authority (NSW)
The University of Western Australia
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT01086930
First received: March 12, 2010
Last updated: August 4, 2011
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Device: ReJoyce Workstation
Other: Standard Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: September 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: 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: 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.
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).
Other: 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086930

Contacts
Contact: Lisa Harvey +61 2 9809 9099 lisa.harvey@sydney.edu.au
Contact: Mary Galea +61 3 9490 7645 m.galea@unimelb.edu.au

Locations
Australia, New South Wales
Spinal Unit, Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia
Contact: Julia Batty    +61 2 9382 5900    julia.batty@sesiahs.health.nsw.gov.au   
Contact: Danielle Collins    +61 2 9382 3149    danielle.collins@sesiahs.health.nsw.gov.au   
Principal Investigator: Julia Batty         
Sub-Investigator: Fernanda Di Natal         
Royal Rehabilitation Centre Sydney Recruiting
Sydney, New South Wales, Australia
Contact: Lisa Harvey    +61 2 98099099    lisa.harvey@sydney.edu.au   
Contact: Anne Thompson    +61 2 9808 9269    ann.thompson@royalrehab.com.au   
Principal Investigator: Anne Thompson         
Sub-Investigator: Lisa Harvey         
Australia, Queensland
Queensland Spinal Cord Injury Service, Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia
Contact: Tim Geraghty    +61 7 3240 2657    Timothy_Geraghty@health.qld.gov.au   
Contact: Polly Tsai    +61 7 3240 5061    polly_tsai@health.qld.gov.au   
Principal Investigator: Tim Geraghty         
Sub-Investigator: Polly Tsai         
Sub-Investigator: Glenda Price         
Australia, South Australia
South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre Recruiting
Northfield, South Australia, Australia
Contact: Ruth Marshall    +61 8 8222 1629    ruth.marshall@health.sa.gov.au   
Contact: Jillian Clark    +61 8 8222 1860    Jillian.Clark@health.sa.gov.au   
Principal Investigator: Ruth Marshall         
Sub-Investigator: Jillian Clark         
Sub-Investigator: Graig Drury         
Australia, Victoria
Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre Recruiting
Kew, Victoria, Australia, 3101
Contact: Mary Galea    +61 3 9490 7645    m.galea@unimelb.edu.au   
Contact: Melanie Hurley    +61 9490 7647    mhurley@unimelb.edu.au   
Principal Investigator: Mary Galea         
Sub-Investigator: Andrew Nunn         
Australia, Western Australia
Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital Recruiting
Shenton Park, Western Australia, Australia
Contact: John Buchanan    +61 8 9382 7171    John.Buchanan@health.wa.gov.au   
Contact: Kate Wisbey    +61 8 9382 7307    Kate.Wisbey@health.wa.gov.au   
Principal Investigator: John Buchanan         
Sub-Investigator: Sarah Dunlop         
Sub-Investigator: Garry Allison         
New Zealand
Burwood Academy Recruiting
Christchurch, New Zealand
Contact: Jo Nunnerley    +64 03 3836833    Joanne.Nunnerley@cdhb.govt.nz   
Contact: Jacqui Prakasim       Jacqueline.Prakasim@middlemore.co.nz   
Principal Investigator: Rick Acland         
Sub-Investigator: Anne Sinnott         
Sponsors and Collaborators
University of Melbourne
Victorian Neurotrauma Initiative
Lifetime Care and Support Authority (NSW)
The University of Western Australia
Investigators
Principal Investigator: Lisa Harvey University of Sydney
Principal Investigator: Mary Galea University of Melbourne
Principal Investigator: Sarah Dunlop The University of Western Australia
  More Information

Additional Information:
No publications provided by University of Melbourne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Mary Galea, University of Melbourne
ClinicalTrials.gov Identifier: NCT01086930     History of Changes
Other Study ID Numbers: SCIPA Hands-On
Study First Received: March 12, 2010
Last Updated: August 4, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014