None listed
Conditions
Brief summary
This study is a multi-centre, assessor-blinded, randomised controlled Phase I trial in people with spinal cord injury. This study is funded by a grant from the Victorian Neurotrauma Initiative. A total of 50 participants with complete or incomplete spinal cord injury will be randomised into two groups: an experimental group and a control group. The control group will undertake a passive cycling program using a bed bike while in the acute ward and an upright bike once they progress to rehabilitation. The experimental group will undertake a FES-assisted cycling program using a bed bike while in the acute ward and an upright bike once they progress to rehabilitation. Both programs will consist of 60 minutes of training 4 times per week for 12 weeks. Training will commence once the participant is considered medically stable (a minimum 5 days post-injury, maximum 4 weeks post-injury). The main objective of the study is to determine the relative effectiveness of FES-assisted cycling compared to passive cycling on muscle cross-sectional area of thigh and calf. The total study duration is 2 years, including an 18month recruitment period, a 12 week treatment period and post-intervention assessments (within a week of last treatment).
Interventions
Group A: FES Cycling Group
Participants assigned to this group will undertake up to 60 minutes (excluding preparation time) of leg cycling 4 days/week for 12 weeks using a Hasomed RehaStim FES Unit attached to a MOTOmed cycle at a pedal cadence between 25-50 rev/min. This can be undertaken as a single session or split into two sessions per day, depending on the participant’s performance and the availability of staff. Surface electrodes will be applied to gluteal, quadriceps, and hamstrings muscl
Group A: FES Cycling Group Participants assigned to this group will undertake up to 60 minutes (excluding preparation time) of leg cycling 4 days/week for 12 weeks using a Hasomed RehaStim FES Unit attached to a MOTOmed cycle at a pedal cadence between 25-50 rev/min. This can be undertaken as a single session or split into two sessions per day, depending on the participant’s performance and the availability of staff. Surface electrodes will be applied to gluteal, quadriceps, and hamstrings muscles (not calves). Stimulation intensity will be gradually increased to a maximum of 140 mA, pulse width of 0.3 – 0.5ms and frequency of 35Hz and this will be sufficient to induce vigorous muscle contractions (Fornusek & Davis, 2008). Participants will exercise at the maximal power output possible at their level of recovery. Therapists will evaluate the degree of muscle contraction, power output and fatigue, and adjust parameters appropriately to maximise time, intensity, and power of training with a principle of overloading the muscle. When fatigue occurs, cycling can be stopped and then re-commenced after a 5 min break if muscle contraction can be elicited again. For participants with some degree of volitional muscle activity, the settings will be adjusted to ensure that resistance is maintained. While patients are confined to bed, the MOTOmed Letto cycle will be attached to the end of the bed and patients will cycle whilst supine. The use of a similar cycle to exercise critically ill patients in ICU has resulted in no adverse events (Burtin et al. 2009). Once mobilised, patients may use an upright RT300 or MOTOmed Viva cycle attached to their wheelchair.
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: a) Have sustained a complete (AIS A) or incomplete SCI (AIS B, C) above T12 no more than 3 weeks previously b) Have undergone internal fixation of spinal fracture or whose fracture is considered sufficiently stable c) Are medically stable d) Are able to provide informed consent e) Have medical and surgical clearance to participate in the study
Exclusion criteria
Participants will be excluded if they: a) Are under 18 years of age b) Are classified as AIS D at baseline c) Are in a halo or receiving any other traction d) Are in ICU e) Have pressure ulcers f) Have peripheral nerve lesion g) Have long bone or pelvic fracture h) Have lower limb amputation i) Have had previous FES to lower limbs j) Are on a ventolator k) Have metabolic bone disease, including lytic or renal bone disease, or senile osteoporosis l) Have had exposure to drugs that affect bone metabolism (amino-bisphosphonate, high dose glucocorticoids, cyclosporine, anti-epileptic drugs [AEDs]) m) Have any contraindications to FES or MRI (cardiac pacemaker, epilepsy, pregnancy, skin grafts, lower limb injuries) n) Have any other contraindications to participating in exercise programs, or outcome assessments, as advised by the treating physician (e.g. autonomic hyper-reflexia, suboptimal oxygen saturation) o) English language competency insufficient to understand research procedures and provide informed consent. p) 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. q) 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