Back to resultsInvestigation Into Optimal FES Training Characteristics After Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
[LO-LONG]
[HI-SHORT
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Functional Electrical Stimulation, Exercise Training, Aerobic Fitness, Muscle Strength
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.
Sites / Locations
- Swiss Paraplegic CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
[HI-SHORT]
[LO-LONG]
Arm Description
High-intensity interval training modality of exercise using FES-evoked leg cycling. Three-four times weekly over 6-8 weeks (24 therapy sessions). 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)
Low-moderate intensity continuous training modality of exercise using FES-evoked leg cycling. Three-four times weekly over 6-8 weeks (24 therapy sessions). The programme is 20+ min continuous exercise. Lower intensity is achieved by lower FES current amplitude (< 90-100 milliampere, patient dependent)
Outcomes
Primary Outcome Measures
Aerobic Fitness
Change of Peak Oxygen Uptake - VO2peak (L/min)
Secondary Outcome Measures
Muscle Near Infrared Spectroscopy
Change of resting muscle arterial oxygen saturation (%)
Strength Fitness
Change of Peak Power Output (Watts)
Full Information
NCT ID
NCT03621254
First Posted
July 13, 2018
Last Updated
October 20, 2023
Sponsor
Swiss Paraplegic Research, Nottwil
1. Study Identification
Unique Protocol Identification Number
NCT03621254
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Functional Electrical Stimulation, Exercise Training, Aerobic Fitness, Muscle Strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[HI-SHORT]
Arm Type
Experimental
Arm Description
High-intensity interval training modality of exercise using FES-evoked leg cycling. Three-four times weekly over 6-8 weeks (24 therapy sessions). 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)
Arm Title
[LO-LONG]
Arm Type
Active Comparator
Arm Description
Low-moderate intensity continuous training modality of exercise using FES-evoked leg cycling. Three-four times weekly over 6-8 weeks (24 therapy sessions). The programme is 20+ min continuous exercise. Lower intensity is achieved by lower FES current amplitude (< 90-100 milliampere, patient dependent)
Intervention Type
Other
Intervention Name(s)
[LO-LONG]
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
[HI-SHORT
Intervention Description
One intervention ([HI-SHORT]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals.
Primary Outcome Measure Information:
Title
Aerobic Fitness
Description
Change of Peak Oxygen Uptake - VO2peak (L/min)
Time Frame
Day 0 to 6 weeks
Secondary Outcome Measure Information:
Title
Muscle Near Infrared Spectroscopy
Description
Change of resting muscle arterial oxygen saturation (%)
Time Frame
Day 0 to 6 Weeks
Title
Strength Fitness
Description
Change of Peak Power Output (Watts)
Time Frame
Day 0 to 6 weeks
Other Pre-specified Outcome Measures:
Title
Muscle Volume
Description
Changes of muscle volume (L)
Time Frame
Day 0 to 6 weeks
Title
Muscle Fatigue
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Glen M Davis, PhD
Phone
+41 41 939 42 06
Email
ines.bersch@paraplegie.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Baumberger, Dr Med
Phone
+41 41 939 52 45
Email
michael.baumberger@paraplegie.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen M Davis, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Baumberger, Dr Med
Organizational Affiliation
Swiss Paraplegic Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ines Bersch-Porada, PhD
Organizational Affiliation
Swiss Paraplegic Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Paraplegic Centre
City
Nottwil
State/Province
LU
ZIP/Postal Code
6207
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ines Bersch, PhD
Phone
+41 41 939 4206
Email
ines.bersch@paraplegie.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury
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