Spinal Cord InjuryPhase 3SCIPAHandsOnNCT01086930
Early Intensive Hand Rehabilitation After Spinal Cord Injury
A Phase 3 study testing ReJoyce Workstation in people with Spinal Cord Injury, run by University of Melbourne at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- ReJoyce Workstation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Sep 2009to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Australia6 sites
Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre
Kew, Victoria, 3101
South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre
Northfield, South Australia
Spinal Unit, Prince of Wales Hospital
Randwick, New South Wales
Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital
Shenton Park, Western Australia
Royal Rehabilitation Centre Sydney
Sydney, New South Wales
Queensland Spinal Cord Injury Service, Princess Alexandra Hospital
Woolloongabba, Queensland
About this study
Official title: SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury
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.
Read the detailed description
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with tetraplegia (a spinal cord injury). A total of 78 participants will be randomised into two groups; 1. the experimental group and 2. the control group. The control group will receive their standard rehabilitation care, while the experimental group will receive the standard rehabilitation care plus the study treatment. The study treatment will consist of one hour of extra hand training, 5 times a week, using a specialised glove which provides electrical impulses to the patient's hand allowing them to open and close their hand. The glove will be used to play games on a specialised computer workstation which focuses on hand movement and function.
The main objective of this study is to determine if the experimental treatment is more effective than standard rehabilitation care alone in participants with tetraplegia.
Total study duration is 3 years, including an 18 month recruitment period, an 8-week treatment period followed by 6 month and 12 month follow up assessments.
The progress of the participant's therapy during the study will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy and occupational therapy assessments which focus on hand function. These involve grasping and releasing different everyday objects and performing everyday tasks as well as quality of life questionnaires.
- Conditions
- Spinal Cord Injury
- Being tested
- ReJoyce Workstation, Standard Care
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReJoyce WorkstationDevice
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.
Standard CareOther
All participants will continue to receive the same standard care for the hand and upper limb as typically provided by their rehabilitation units.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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 Receives: Device: ReJoyce Workstation; Other: Standard Care |
| Standard Care Group | Other | 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). Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Action Research Arm Test
A standardized measure of unilateral hand and upper limb function
Measured: 8 weeks and 26 weeks
Secondary outcomes (10)
Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension
Summed strength score of 10 upper limb muscles
Measured: 8 weeks and 26 weeks
Sensory Score on ISNCSCI
Scores for light touch and pinprick tested in dermatomes of the upper limb
Measured: 8 weeks and 26 weeks
AsTex Sensory Test
A measure of texture discrimination in the fingertips
Measured: 8 weeks and 26 weeks
AuSpinal Test
A test of hand function
Measured: 8 weeks and 26 weeks
Capabilities of Upper Extremity
A questionnaire about upper limb function
Measured: 8 weeks and 26 weeks
Assessment of Quality of Life (AQoL)
A questionnaire to assess quality of life
Measured: 8 weeks and 26 weeks
Health Utilities Index Mark 3
A questionnaire to assess quality of life, but includes a domain on hand function
Measured: 8 weeks and 24 weeks
Self-care subscale of the Spinal Cord Independence Measure
A questionnaire about independence in self-care
Measured: 8 weeks and 24 weeks
Goal Attainment Scale
An assessment of whether a participant achieved pre-set goals
Measured: 8 weeks
Participant Perception of Treatment Effectiveness
Self resport of treatment effectiveness
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Austin Hospital, Melbourne Australia, Hampstead Rehabilitation Centre Adelaide, Shenton Park Rehabilitation Centre Perth, Princess Alexandra Hospital, Brisbane, Australia, Royal Rehabilitation Centre Sydney, Prince of Wales Hospital, Sydney, Burwood Hospital, Christchurch, New Zealand
- Responsible party
- Principal investigator, Mary Galea, University of Melbourne
- Investigators
- Lisa Harvey, Principal investigator, University of SydneyMary Galea, Principal investigator, University of MelbourneSarah Dunlop, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086930
- Sponsor's protocol ID
- SCIPA Hands-On
- Acronym
- SCIPAHandsOn
- Status last verified
- Apr 2021
- First submitted
- 12 Mar 2010
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will only be provided in aggregate. No individual data will be released, as per the ethics approval.
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.
PubMed 21235821Harvey 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.
PubMed 27008910Harvey 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.
PubMed 28970100
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01086930
- Acronym / sponsor ID
- SCIPAHandsOn / SCIPA Hands-On
- Conditions
- Spinal Cord Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Austin Hospital, Melbourne Australia, Hampstead Rehabilitation Centre Adelaide, Shenton Park Rehabilitation Centre Perth, Princess Alexandra Hospital, Brisbane, Australia, Royal Rehabilitation Centre Sydney, Prince of Wales Hospital, Sydney, Burwood Hospital, Christchurch, New Zealand
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with tetraplegia (a spinal cord injury). A total of 78 participants will be randomised into two groups; 1. the experimental group and 2. the control group. The control group will receive their standard rehabilitation care, while the experimental group will receive the standard rehabilitation care plus the study treatment. The study treatment will consist of one hour of extra hand training, 5 times a week, using a specialised glove which provides electrical impulses to the patient's hand allowing them to open and close their hand. The glove will be used to play games on a specialised computer workstation which focuses on hand movement and function.
The main objective of this study is to determine if the experimental treatment is more effective than standard rehabilitation care alone in participants with tetraplegia.
Total study duration is 3 years, including an 18 month recruitment period, an 8-week treatment period followed by 6 month and 12 month follow up assessments.
The progress of the participant's therapy during the study will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy and occupational therapy assessments which focus on hand function. These involve grasping and releasing different everyday objects and performing everyday tasks as well as quality of life questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: ReJoyce Workstation, Other: Standard CareIn 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 |
| Standard Care Group | Other | Other: Standard CareParticipants 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). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReJoyce WorkstationThe 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. | Device | Intervention Group |
| Standard CareAll participants will continue to receive the same standard care for the hand and upper limb as typically provided by their rehabilitation units. | Other | Intervention Group, Standard Care Group |
Primary outcome
Modified Action Research Arm Test
Time frame: 8 weeks and 26 weeks
A standardized measure of unilateral hand and upper limb function
10 secondary outcomes
Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension
Time frame: 8 weeks and 26 weeks
Sensory Score on ISNCSCI
Time frame: 8 weeks and 26 weeks
AsTex Sensory Test
Time frame: 8 weeks and 26 weeks
AuSpinal Test
Time frame: 8 weeks and 26 weeks
Capabilities of Upper Extremity
Time frame: 8 weeks and 26 weeks
Assessment of Quality of Life (AQoL)
Time frame: 8 weeks and 26 weeks
Health Utilities Index Mark 3
Time frame: 8 weeks and 24 weeks
Self-care subscale of the Spinal Cord Independence Measure
Time frame: 8 weeks and 24 weeks
Goal Attainment Scale
Time frame: 8 weeks
Participant Perception of Treatment Effectiveness
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Background: PubMed 21235821Harvey 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.
- Results publication: PubMed 27008910Harvey 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.
- Derived from this study: PubMed 28970100Harvey 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.
- Individual participant dataSharing planned: No. Data will only be provided in aggregate. No individual data will be released, as per the ethics approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Harvey principal investigator
University of Sydney
Mary Galea principal investigator
University of Melbourne
Sarah Dunlop principal investigator
The University of Western Australia
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ReJoyce Workstation in people with Spinal Cord Injury, run by University of Melbourne at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Action Research Arm Test (time frame: 8 weeks and 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01086930, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.