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Trial record 41 of 320 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Investigation Into Optimal FES Training Characteristics After Sub-acute Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03621254
Recruitment Status : Not yet recruiting
First Posted : August 8, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

Brief Summary:
The aim of this study is to investigate two different modalities of functional electrical stimulation (FES) leg exercise in sub-acute 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 MotionMaker™ exercise ergometer for 6 weeks, three times per week. [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-weeks of training has been completed.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Other: [LO-LONG] Other: [HI-SHORT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised Controlled Design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation Into Optimal FES Training Characteristics After Sub-acute Spinal Cord Injury
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: [HI-SHORT]
High-intensity interval training modality of exercise using FES-evoked leg cycling. Three times weekly over 6 weeks. The programme is 10 x 2-min exercise intervals with 1-2 min of recovery between intervals. High intensity is achieved by high FES current amplitude (120-150 milliampere, patient dependent)
Other: [HI-SHORT
One intervention ([HI-SHORT]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals.

Active Comparator: [LO-LONG]
Low-moderate intensity continuous training modality of exercise using FES-evoked leg cycling. Three times weekly over 6 weeks. The programme is 20+ min continuous exercise. Lower intensity is achieved by lower FES current amplitude (< 90-100 milliampere, patient dependent)
Other: [LO-LONG]
Both interventions are different modalities of FES-evoked leg exercise, three times per week for 6-weeks. The comparator intervention ([LO-LONG]) uses 20-40 min (patient state of fitness dependent) of continuous leg exercise of lower intensity.




Primary Outcome Measures :
  1. Aerobic Fitness [ Time Frame: Day 0 to 6 weeks ]
    Change of Peak Oxygen Uptake - VO2peak (L/min)


Secondary Outcome Measures :
  1. Muscle Near Infrared Spectroscopy [ Time Frame: Day 0 to 6 Weeks ]
    Change of resting muscle arterial oxygen saturation (%)

  2. Strength Fitness [ Time Frame: Day 0 to 6 weeks ]
    Change of Peak Power Output (Watts)


Other Outcome Measures:
  1. Muscle Volume [ Time Frame: Day 0 to 6 weeks ]
    Changes of muscle volume (L)

  2. Muscle Fatigue [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than 6-weeks post-trauma, but less than 12-weeks 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 18-65 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621254


Contacts
Contact: Glen M Davis, PhD +41 41 939 59 72 glen.davis@paraplegie.ch
Contact: Michael Baumberger, Dr Med +41 41 939 52 45 michael.baumberger@paraplegie.ch

Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Glen M Davis, PhD Swiss Paraplegic Centre
Principal Investigator: Michael Baumberger, Dr Med Swiss Paraplegic Centre
Principal Investigator: Ines Bersch-Porada Swiss Paraplegic Centre
Principal Investigator: Angela Frotzler, Dr rer biol hum Swiss Paraplegic Centre

Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT03621254     History of Changes
Other Study ID Numbers: 2018-11
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Paraplegic Centre Nottwil:
Functional Electrical Stimulation
Exercise Training
Aerobic Fitness
Muscle Strength

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System