Status:
COMPLETED
SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury
Lead Sponsor:
University of Melbourne
Collaborating Sponsors:
Austin Health
Hampstead Rehabilitation Centre Adelaide
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT01236976
Start Date
December 1 2010
End Date
June 1 2016
Last Update
May 3 2021
Active Locations (6)
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1
Spinal Unit, Prince of Wales Hospital
Randwick, New South Wales, Australia
2
Royal Rehabilitation Centre Sydney
Sydney, New South Wales, Australia
3
South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre
Northfield, South Australia, Australia
4
Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre
Kew, Victoria, Australia, 3101