SCIPA (Spinal Cord Injury and Physical Activity) Full-On: Intensive Exercise Program After Spinal Cord Injury
- Conditions
- Spinal Cord InjuryInjuries and Accidents - Other injuries and accidentsNeurological - Other neurological disorders
- Registration Number
- ACTRN12610000498099
- Lead Sponsor
- The University of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 188
Participants will be included if they:
1. Have sustained a traumatic spinal cord injury (SCI) a minimum of 6 months prior to consent and have completed their primary rehabilitation
2. Are 18 years or older and able to give informed consent
3. Have a complete or incomplete spinal cord injury between C6 and T12 (as per the International Standardised Neurological Assessment for SCI)
4. Are able and willing to attend an exercise program 3 times per week for 12 weeks
5. Are considered by their medical consultant to be fit to undertake the exercise program (documented approval by the medical consultant is required).
Participants will not be included if they:
1. Have brachial plexus, cauda equina, or peripheral nerve injury
2. Have had recent major trauma or surgery within the last 6 months
3. Have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification
4. Are post-menopausal at time of injury (females)
5. Have Body Mass Index (BMI) at injury falling below lower threshold of healthy adult reference range
6. Have endocrinopathy or metabolic disorders of bone, such as Paget’s disease, lytic or renal bone disease and senile osteoporosis
7. have medical history of exposure to medication(s) known to affect mineral ion or bone metabolism
8. Have chronic systemic diseases, e.g. Hepatitis C (Hep C), Human Immunodeficiency Virus-Acquired Immunodeficiency Syndrome (HIV-AIDs)
9. Have significant impairment or disability, including physical, neurological or psychological impairments
10. Have a history of long bone fracture, or family history of fragility fracture
11. Have medical fragility, e.g. BMI falling below lower threshold of healthy adult reference range, or history of recurrent hospital readmissions.
12. Have extensive fixed contractures in upper or lower limbs
13. Have severe spasticity
14. Have uncontrolled neuropathic pain
15. Are likely to experience clinically significant autonomic dysreflexia and/or hypotension in response to electrical stimulation or prolonged upright posture
16. Are unable to attend the 6-month and 12 month follow-up assessments at their treating spinal unit
17. Have any contraindications to Functional Electrical Stimulation (FES) such as cardiac pacemaker, epilepsy, lower limb fracture or pregnancy
18. Have intracranial metal implants (for Transcranial Magnetic Stimulation (TMS) only)
19. 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.
20. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the change in American Spinal Injury Association classification (ASIA) Motor Score at 12 weeks (Post Intervention Assessment) compared to baseline[Following 12 weeks of treatment compared to baseline]
- Secondary Outcome Measures
Name Time Method