None listed
Conditions
Brief summary
The main objective of the study is to determine whether the comprehensive exercise program leads to better neurological recovery than the upper body training program. Both programs are likely to lead to improvements in health and fitness
Interventions
Group A - Experimental Group - comprehensive exercise program: Body weight supported treadmill training (Therastride System, Food and Drug Administration (FDA) registration number 890.5380) allows spinal cord injured patients to stand suspended in a harness by an overhead pulley on a specially designed treadmill for locomotor training. Functional Electrical Stimulation-assisted cycling (RT-300 cycle ergometer) allows spinal cord injured patients to actively exercise using coordinated electrical
Group A - Experimental Group - comprehensive exercise program: Body weight supported treadmill training (Therastride System, Food and Drug Administration (FDA) registration number 890.5380) allows spinal cord injured patients to stand suspended in a harness by an overhead pulley on a specially designed treadmill for locomotor training. Functional Electrical Stimulation-assisted cycling (RT-300 cycle ergometer) allows spinal cord injured patients to actively exercise using coordinated electrically evoked/enhanced muscle contractions while remaining seated in their wheelchair (fully compliant with 21 Code of Federal Regulations (CFR) Part 820, United States of America (US) FDA Quality Systems Regulations). Trunk and lower extremity exercises will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality. These may be provided in lying (e.g. supine, prone) and in weight-bearing positions (e.g. kneeling, standing). Task specific practice of functional tasks, involving moving the upper body over and outside the base of support, will also be undertaken. This comprehensive exercise program will be conducted 2-3 hours per day, 3 times per week for 12 weeks. Every session will contain all exercises where possible; the amount of time devoted to each component will vary according to a participant's ability and endurance. The aim is to build up the amount of exercise to three hours per session in total. The exercise program will be supervised by a physiotherapist with assistance from an exercise physiologist and/or physiotherapy assistants. The amount of supervision will vary according to the activity, e.g. one-on-one supervision for the trunk and limb exercises, four-on-one for treadmill training.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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).
Exclusion criteria
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.
Outcome results
None listed