Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSwiss Paraplegic Research, Nottwil

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • [LO-LONG]

    Other intervention

    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.

  • [HI-SHORT

    Other intervention

    One intervention (\[HI-SHORT\]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: [HI-SHORT]Experimental treatment 1 intervention
Group B: [LO-LONG]Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Aerobic Fitness

Change of Peak Oxygen Uptake - VO2peak (L/min)

Time frame
Day 0 to 6 weeks

Secondary outcomes

1

Muscle Near Infrared Spectroscopy

Change of resting muscle arterial oxygen saturation (%)

Time frame
Day 0 to 6 Weeks
2

Strength Fitness

Change of Peak Power Output (Watts)

Time frame
Day 0 to 6 weeks

Other outcomes

1

Muscle Volume

Changes of muscle volume (L)

Time frame
Day 0 to 6 weeks
2

Muscle Fatigue

Changes of time (sec) until muscle fatigue occurs as defined by fall of Power Output (Watts) to 20% of original value

Time frame
Day 0 to 6 weeks

Sponsors and contacts

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