Spinal Cord Injury
Conditions
Keywords
Functional Electrical Stimulation, Exercise Training, Aerobic Fitness, Muscle Strength
Brief summary
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.
Interventions
OTHER[LO-LONG]
Both 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.
OTHER[HI-SHORT
One intervention (\[HI-SHORT\]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals.
Sponsors
Swiss Paraplegic Research, Nottwil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised Controlled Design
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Both male and female. * Have at least 90º bilateral knee flexion. * Able to perform FES muscle contractions (not FES intolerant). * Able to follow verbal instructions.
Exclusion criteria
* 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. * History of cardiovascular / cardiorespiratory disease contraindicating exercise. * Uncontrolled orthostatic hypotension. * Unhealed decubiti at electrode placement area. * Recurrent and uncontrolled autonomic dysreflexia. * Active heterotopic ossification. * Other peripheral or central neurologic injury.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic Fitness | Day 0 to 6 weeks | Change of Peak Oxygen Uptake - VO2peak (L/min) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Near Infrared Spectroscopy | Day 0 to 6 Weeks | Change of resting muscle arterial oxygen saturation (%) |
| Strength Fitness | Day 0 to 6 weeks | Change of Peak Power Output (Watts) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Muscle Volume | Day 0 to 6 weeks | Changes of muscle volume (L) |
| Muscle Fatigue | Day 0 to 6 weeks | Changes of time (sec) until muscle fatigue occurs as defined by fall of Power Output (Watts) to 20% of original value |
Countries
Switzerland
Contacts
Primary ContactInes Bersch, PhD
Backup ContactKathrin Schafer, MPH
Outcome results
None listed