Clinical trial NCT03621254: Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury
Official title: Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Functional Electrical Stimulation
Exercise Training
Aerobic Fitness
Muscle Strength
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2018-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Aerobic Fitness
timeFrame: Day 0 to 6 weeks
Secondary outcomes:
measure: Muscle Near Infrared Spectroscopy
timeFrame: Day 0 to 6 Weeks
measure: Strength Fitness
timeFrame: Day 0 to 6 weeks
Other outcomes:
measure: Muscle Volume
timeFrame: Day 0 to 6 weeks
measure: Muscle Fatigue
timeFrame: Day 0 to 6 weeks
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
affiliation: University of Sydney
name: Glen M Davis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: