Spinal Cord InjuryPhase 3SCIPAFull-OnNCT01236976
SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury
A Phase 3 study testing Therastride Treadmill System, FES-assisted cycling and Trunk and upper and lower limb exercises in people with Spinal Cord Injury, run by University of Melbourne at 6 sites in 2 countries.
Trial summary
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Therastride Treadmill System, FES-assisted cycling and Trunk and upper and lower limb exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Dec 2010to Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have sustained a traumatic spinal cord injury a minimum of 6 months prior to consent and have completed their primary rehabilitation
- Are 18 years or older and able to give informed consent
- Have a complete or incomplete spinal cord injury between C6 and T12 (as per the International Standardised Neurological Assessment for SCI)
- Are able and willing to attend an exercise program 3 times per week for 12 weeks
- Are considered by their medical consultant to be fit to undertake the exercise program (documented approval by medical consultant required).
Who cannot join
- Have brachial plexus, cauda equina, or peripheral nerve injury
- Have had recent major trauma or surgery within the last 6 months
- Have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification
- Are post-menopausal at time of injury (females)
- Have BMI at injury falling below lower threshold of healthy adult reference range
- Have endocrinopathy or metabolic disorders of bone, such as Paget's disease, lytic or renal bone disease and senile osteoporosis
Show all 20Show fewer
- have medical history of exposure to medication(s) known to affect mineral ion or bone metabolism
- Have chronic systemic diseases, e.g. Hep C, HIV-AIDs
- Have significant impairment or disability, including physical, neurological or psychological impairments
- Have a history of long bone fracture, or family history of fragility fracture
- Have medical fragility, e.g. BMI falling below lower threshold of healthy adult reference range, or history of recurrent hospital readmissions.
- Have extensive fixed contractures in upper or lower limbs
- Have severe spasticity
- Have uncontrolled neuropathic pain
- Are likely to experience clinically significant autonomic dysreflexia and/or hypotension in response to electrical stimulation or prolonged upright posture
- Are unable to attend the 6-month and 12 month follow-up assessments at their treating spinal unit
- Have any contraindications to FES such as cardiac pacemaker, epilepsy, lower limb fracture or pregnancy
- Have intracranial metal implants (for TMS only)
- 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 adherence to the Protocol.
- Are participating in any other therapy (including alternative therapies) or taking medications (including herbal preparations) that are not considered to be standard care as per the protocol.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Australia5 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
About this study
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. The control group participants will receive an upper body strength and fitness program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental group participants will receive a comprehensive full body exercise program, conducted for 2-3 hours, three times per week for 12 weeks.
The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury.
Read more
Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week treatment period followed by 6 month and 12 month (from baseline) follow up assessments.
Participants will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy, neurophysiological, fitness and functional tests, psychological and quality of life questionnaires, as well as tests of immune function and bone structure.
Read the detailed description
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. The control group participants will receive an upper body strength and fitness program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental group articipants will receive a comprehensive full body exercise program, conducted for 2-3 hours, three times per week for 12 weeks.
The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury.
Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week treatment period followed by 6 month and 12 month (from baseline) follow up assessments.
Participants will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy, neurophysiological, fitness and functional tests, psychological and quality of life questionnaires, as well as tests of immune function and bone structure.
- Conditions
- Spinal Cord Injury
- Being tested
- Therastride Treadmill System, FES-assisted cycling, Trunk and upper and lower limb exercises, Upper body strength and fitness program
- 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.
Therastride Treadmill SystemDevice
This device supports spinal cord injured patients to stand (suspended in a harness by an overhead pulley) on the specially designed treadmill for locomotor training. It is registered with the FDA (Regulation Number 890.5380).
FES-assisted cyclingDevice
This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD).
Trunk and upper and lower limb exercisesOther
This intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality.
Upper body strength and fitness programOther
This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in Group A will receive a triad of interventions comprising body weight supported treadmill training (BWSTT) using the Therastride Treadmill System, functional electrical stimulation (FES)-assisted cycling, and trunk and upper and lower limb exercise. These interventions will be provided at the spinal unit. Receives: Device: Therastride Treadmill System; Device: FES-assisted cycling; Other: Trunk and upper and lower limb exercises |
| Control Group | Other | Participants in Group B will receive an upper body strength and fitness program. This program may be provided at the spinal unit, or an appropriately equipped gymnasium as approved by the SCIPA Full-On Project Committee. It will be based on the Burn Rubber Burn (BRB) exercise program already established in Sydney. BRB is a circuit-based exercise program incorporating resistance and cardiovascular training. For this protocol, the circuit will comprise several stations using different pieces of equipment. Receives: Other: Upper body strength and fitness program |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Austin Health, Hampstead Rehabilitation Centre Adelaide, Shenton Park Rehabilitation Centre Perth, Royal Rehabilitation Centre Sydney, Prince of Wales Hospital, Sydney, Burwood Hospital, Christchurch, New Zealand
- Responsible party
- Principal investigator, Mary Galea, University of Melbourne
- Investigators
- Prof Mary Galea, Principal investigator, University of MelbourneProf Glen Davis, Principal investigator, University of SydneyProf Sarah Dunlop, Principal investigator, The University of Western AustraliaDr Andrew Nunn, Principal investigator, Austin HealthDr Tim Geraghty, Principal investigator, Princess Alexandra Hospital Brisbane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236976
- Sponsor's protocol ID
- SCIPA Full-On
- Acronym
- SCIPAFull-On
- Status last verified
- Apr 2021
- First submitted
- 8 Nov 2010
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Aggregate data only. Individual participant data will not be provided as per the ethics approval.
Publications
Galea MP, Dunlop SA, Davis GM, Nunn A, Geraghty T, Hsueh YS, Churilov L. Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial. Trials. 2013 Sep 11;14:291. doi: 10.1186/1745-6215-14-291.
PubMed 24025260Galea MP, Dunlop SA, Geraghty T, Davis GM, Nunn A, Olenko L; SCIPA Switch-On Trial Collaborators<xref ref-type="fn" rid="fn1-1545968318771213" ptype="f1545968318771213" citart="citart1">*</xref>. SCIPA Full-On: A Randomized Controlled Trial Comparing Intensive Whole-Body Exercise and Upper Body Exercise After Spinal Cord Injury. Neurorehabil Neural Repair. 2018 Jun;32(6-7):557-567. doi: 10.1177/1545968318771213. Epub 2018 May 7.
PubMed 35545824
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 Full-On :Intensive Exercise Program After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01236976
- Acronym / sponsor ID
- SCIPAFull-On / SCIPA Full-On
- Conditions
- Spinal Cord Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Austin Health, Hampstead Rehabilitation Centre Adelaide, Shenton Park Rehabilitation Centre Perth, Royal Rehabilitation Centre Sydney, Prince of Wales Hospital, Sydney, Burwood Hospital, Christchurch, New Zealand
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Nov 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.
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. The control group participants will receive an upper body strength and fitness program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental group participants will receive a comprehensive full body exercise program, conducted for 2-3 hours, three times per week for 12 weeks.
The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury.
Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week treatment period followed by 6 month and 12 month (from baseline) follow up assessments.
Participants will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy, neurophysiological, fitness and functional tests, psychological and quality of life questionnaires, as well as tests of immune function and bone structure.
Detailed description
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. The control group participants will receive an upper body strength and fitness program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental group articipants will receive a comprehensive full body exercise program, conducted for 2-3 hours, three times per week for 12 weeks.
The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury.
Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week treatment period followed by 6 month and 12 month (from baseline) follow up assessments.
Participants will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy, neurophysiological, fitness and functional tests, psychological and quality of life questionnaires, as well as tests of immune function and bone structure.
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: Therastride Treadmill System, Device: FES-assisted cycling, Other: Trunk and upper and lower limb exercisesParticipants in Group A will receive a triad of interventions comprising body weight supported treadmill training (BWSTT) using the Therastride Treadmill System, functional electrical stimulation (FES)-assisted cycling, and trunk and upper and lower limb exercise. These interventions will be provided at the spinal unit. |
| Control Group | Other | Other: Upper body strength and fitness programParticipants in Group B will receive an upper body strength and fitness program. This program may be provided at the spinal unit, or an appropriately equipped gymnasium as approved by the SCIPA Full-On Project Committee. It will be based on the Burn Rubber Burn (BRB) exercise program already established in Sydney. BRB is a circuit-based exercise program incorporating resistance and cardiovascular training. For this protocol, the circuit will comprise several stations using different pieces of equipment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have sustained a traumatic spinal cord injury a minimum of 6 months prior to consent and have completed their primary rehabilitation
- Are 18 years or older and able to give informed consent
- Have a complete or incomplete spinal cord injury between C6 and T12 (as per the International Standardised Neurological Assessment for SCI)
- Are able and willing to attend an exercise program 3 times per week for 12 weeks
- Are considered by their medical consultant to be fit to undertake the exercise program (documented approval by medical consultant required).
Key exclusion criteria (20 listed)
- Have brachial plexus, cauda equina, or peripheral nerve injury
- Have had recent major trauma or surgery within the last 6 months
- Have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification
- Are post-menopausal at time of injury (females)
- Have BMI at injury falling below lower threshold of healthy adult reference range
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 |
|---|---|---|
| Therastride Treadmill SystemThis device supports spinal cord injured patients to stand (suspended in a harness by an overhead pulley) on the specially designed treadmill for locomotor training. It is registered with the FDA (Regulation Number 890.5380). | Device | Intervention Group |
| FES-assisted cyclingThis intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD). | Device | Intervention Group |
| Trunk and upper and lower limb exercisesThis intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality. | Other | Intervention Group |
| Upper body strength and fitness programThis intervention is a circuit-based exercise program incorporating resistance and cardiovascular training. | Other | Control Group |
Primary outcome
To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement.
Time frame: 12 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 24025260Galea MP, Dunlop SA, Davis GM, Nunn A, Geraghty T, Hsueh YS, Churilov L. Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial. Trials. 2013 Sep 11;14:291. doi: 10.1186/1745-6215-14-291.
- Results publication: PubMed 35545824Galea MP, Dunlop SA, Geraghty T, Davis GM, Nunn A, Olenko L; SCIPA Switch-On Trial Collaborators<xref ref-type="fn" rid="fn1-1545968318771213" ptype="f1545968318771213" citart="citart1">*</xref>. SCIPA Full-On: A Randomized Controlled Trial Comparing Intensive Whole-Body Exercise and Upper Body Exercise After Spinal Cord Injury. Neurorehabil Neural Repair. 2018 Jun;32(6-7):557-567. doi: 10.1177/1545968318771213. Epub 2018 May 7.
- Individual participant dataSharing planned: No. Aggregate data only. Individual participant data will not be provided 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.
Prof Mary Galea principal investigator
University of Melbourne
Prof Glen Davis principal investigator
University of Sydney
Prof Sarah Dunlop principal investigator
The University of Western Australia
6 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 Therastride Treadmill System, FES-assisted cycling and Trunk and upper and lower limb exercises in people with Spinal Cord Injury, run by University of Melbourne at 6 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 5 inclusion and 20 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 6 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?
To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement. (time frame: 12 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 NCT01236976, which also lists 2 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.