Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03621254
• Other study ID #: 2018-11
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Swiss Paraplegic Research, Nottwil
• Contact: Glen M Davis, PhD
• Phone: +41 41 939 42 06
• Email: ines.bersch[@]paraplegie.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscle Volume	Changes of muscle volume (L)	Day 0 to 6 weeks
Other	Muscle Fatigue	Changes of time (sec) until muscle fatigue occurs as defined by fall of Power Output (Watts) to 20% of original value	Day 0 to 6 weeks
Primary	Aerobic Fitness	Change of Peak Oxygen Uptake - VO2peak (L/min)	Day 0 to 6 weeks
Secondary	Muscle Near Infrared Spectroscopy	Change of resting muscle arterial oxygen saturation (%)	Day 0 to 6 Weeks
Secondary	Strength Fitness	Change of Peak Power Output (Watts)	Day 0 to 6 weeks