Spinal Cord Injury
Conditions
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 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.
Interventions
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).
DEVICEFES-assisted cycling
This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD).
OTHERTrunk and upper and lower limb exercises
This intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality.
OTHERUpper body strength and fitness program
This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.
Sponsors
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
University of Melbourne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have sustained a traumatic spinal cord injury 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 medical consultant required).
Exclusion criteria
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 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. Hep C, 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 FES such as cardiac pacemaker, epilepsy, lower limb fracture or pregnancy 18. Have intracranial metal implants (for 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement. | 12 weeks |
Countries
Australia, New Zealand
Outcome results
None listed