About this trial
The aim of this study is to investigate two different modalities of functional electrical stimulation (FES) leg exercise in patients with spinal cord injury (SCI). The primary outcomes being compared are 1. FES-induced leg aerobic fitness, and 2. FES-induced leg strength. There will be two FES-leg training groups, and sub-acute patients with SCI will be randomised between the groups - high-short \[HI-SHORT\] and low-long \[LO-LONG\]. Both groups (n=10 per group) will exercise on the Hasomed RehaStim™ exercise ergometer for 6-8 weeks, three-four times per week (24 therapy sessions). \[HI-SHORT\] will perform 10 x 2-min of high-intensity interval training with a recovery of 1-2 min between exercise bouts. \[LO-LONG\] will perform 20+ min of continuous exercise at a low-moderate exercise intensity. Exercise intensity for \[HI-SHORT\] and \[LO-LONG\] will be titrated by neuromuscular stimulation characteristics. The primary outcomes will be assessed before training commences and after 6-8 weeks of training has been completed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Greater than 6-weeks post-trauma after SCI.
Traumatic and atraumatic spinal cord injuries between C7 and T10
Participants diagnosed with "motor complete' spinal cord injury American Spinal Injury Association Impairment Scale A and B.
Age between 18-75 years old.
Disqualifiers
A recent history of trauma to the lower limb.
Severe or infected pressure sore on weight-bearing skin areas.
Illness caused by acute urinary tract infection.
Uncontrolled spasticity or pain.
Trial design
Parallel
Treatments tested in this trial
[LO-LONG]
Other interventionBoth interventions are different modalities of FES-evoked leg exercise, three-four times per week for 6-8 weeks (24 therapy sessions). The comparator intervention (\[LO-LONG\]) uses 20-40 min (patient state of fitness dependent) of continuous leg exercise of lower intensity.
[HI-SHORT
Other interventionOne intervention (\[HI-SHORT\]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals.
Treatment groups
Trial outcomes
Primary outcomes
Aerobic Fitness
Change of Peak Oxygen Uptake - VO2peak (L/min)
Secondary outcomes
Muscle Near Infrared Spectroscopy
Change of resting muscle arterial oxygen saturation (%)
Strength Fitness
Change of Peak Power Output (Watts)
Other outcomes
Muscle Volume
Changes of muscle volume (L)
Muscle Fatigue
Changes of time (sec) until muscle fatigue occurs as defined by fall of Power Output (Watts) to 20% of original value
Sponsors and contacts
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