SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury (SCIPA Hands-On)
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| ClinicalTrials.gov Identifier: NCT01086930 |
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Recruitment Status : Unknown
Verified March 2010 by University of Melbourne.
Recruitment status was: Recruiting
First Posted : March 15, 2010
Last Update Posted : August 5, 2011
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Sponsor:
University of Melbourne
Collaborators:
Victorian Neurotrauma Initiative
Lifetime Care and Support Authority (NSW)
The University of Western Australia
Information provided by:
University of Melbourne
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Cord Injury | Device: ReJoyce Workstation Other: Standard Care | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 78 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury |
| Study Start Date : | September 2009 |
| Estimated Primary Completion Date : | December 2012 |
| Estimated Study Completion Date : | December 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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:
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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. |
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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).
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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. |
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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients will be included if they:
- have sustained a 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 as part of their standard medical/rehabilitation care
- 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 shoulder/s to 60 degrees
- have reduced ability to grasp using their hands
- are able to tolerate sufficient 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
Exclusion Criteria:
Patients will not be included if they:
- 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
- might 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof Mary Galea, University of Melbourne |
| ClinicalTrials.gov Identifier: | NCT01086930 |
| Other Study ID Numbers: |
SCIPA Hands-On |
| First Posted: | March 15, 2010 Key Record Dates |
| Last Update Posted: | August 5, 2011 |
| Last Verified: | March 2010 |
Additional relevant MeSH terms:
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Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |