Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Milos Popovic, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00201968
First received: September 12, 2005
Last updated: February 25, 2013
Last verified: February 2013

September 12, 2005
February 25, 2013
April 2005
April 2013   (final data collection date for primary outcome measure)
  • Whole body muscle mass via dual-energy x-ray absorptiometry [ Time Frame: Baseline, 4 month and 12 months ] [ Designated as safety issue: No ]
  • Bone density at different hip, spine, proximal and distal femur and proximal Tibia using dual-energy xray absorptiometry [ Time Frame: Baseline, 4 month and 12 months ] [ Designated as safety issue: No ]
  • Bone density, bone geometry and muscle area via computed tomography, [ Time Frame: Baseline, 4 month and 12 months ] [ Designated as safety issue: No ]
  • Spasticity via Ashworth Scale and Pendulum Test, and [ Time Frame: Baseline, 4 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Factor analysis of electromyography and kinematics of gait. [ Time Frame: Baseline, 4months and 6 months ] [ Designated as safety issue: No ]
  • -Whole body muscle mass via dual-energy x-ray absorptiometry
  • -Bone density at hip, spine, proximal tibia and distal femur using dual-energy xray absorptiometry
  • -Bone density, bone geometry and muscle area via computed tomography
  • -Spasticity via Ashworth Scale and Pendulum Test
  • -Factor analysis of electromyography and kinematics of gait
  • All of the measures below at 4 months:
Complete list of historical versions of study NCT00201968 on ClinicalTrials.gov Archive Site
  • Incidence of urinary tract infections, [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Spinal cord independence measure, [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Urinary N-telopeptide and serum osteocalcin, [ Time Frame: Baseline, 4 month, 6 month and 12 months ] [ Designated as safety issue: No ]
  • Timed up and go and two-minute walk test (functional mobility), [ Time Frame: Baseline, 4 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Incidence of pressure sores, [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Reintegration to normal living index, [ Time Frame: Baseline, 4, 6 and 12 months ] [ Designated as safety issue: No ]
  • Satisfaction with life scale, [ Time Frame: Baseline, 4 , 6 and 12 months ] [ Designated as safety issue: No ]
  • Instrumental Activities of Daily Living SubScale, [ Time Frame: Baseline, 4, 6 and 12 months ] [ Designated as safety issue: No ]
  • Craig Handicap assessment and reporting technique, and [ Time Frame: Baseline, 4, 6 and 12 months ] [ Designated as safety issue: No ]
  • client perception of treatment (qualitative). [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • All of the measures above at 6 months, and 12 months, as well as the measures below at 4 months, 6 months and 12 months:
  • -incidence of urinary tract infections
  • -spinal cord independence measure
  • -urinary N-telopeptide and serum osteocalcin
  • -timed up and go and 2-minute walk test (functional mobility)
  • -incidence of pressure sores
  • -reintigration to normal living index
  • -satisfaction with life scale
  • -Instrumental Activities of Daily Living SubScale
  • -Craig Handicap assessment and reporting technique
  • -client perception of treatment (qualitative)
Not Provided
Not Provided
 
Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury
Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury

The purpose of this study is to evaluate whether an aerobic and resistance training program or a functional electrical stimulation-assisted Walking program is more effective for reducing health complications related to spinal cord injury, for example, the occurrence of bladder infections, pressure sores and/or frequency of spasms. It is hypothesized that the functional electrical stimulation-assisted walking will have a greater impact on secondary complications than the aerobic and resistance training program.

A barrier to maintaining health status and active social participation in the community for individuals with spinal cord injury (SCI) is the broad number of secondary medical complications typically associated with their injury, such as bone loss, spasticity, urinary tract infections and pressure sores. Functional electrical stimulation (FES) is an intervention that applies short current pulses to muscles and causes them to contract. FES can be applied to individuals with SCI to help them restore functions such as walking and grasping by contracting groups of paralyzed muscles in an orchestrated manner. Pilot work conducted by our research group suggests that applying FES to augment functional improvement often reduces incidents of secondary complications such as spasticity, pressure sores, and swelling of the legs. Specifically, functional and meaningful walking tasks performed on a regular basis with the help of FES therapy have the potential to improve overall physical and psychological well being of persons with incomplete SCI. This study seeks to demonstrate that thrice-weekly FES training for 4 months can restore/improve walking function in chronic, incomplete SCI individuals and that this therapy will considerably reduce the occurrences of secondary complications due to SCI. This will subsequently promote opportunities for active social participation and enhance the quality of life for SCI consumers. Comparison: 32 individuals with chronic, incomplete SCI will be randomized to either thrice-weekly FES therapy OR thrice-weekly aerobic and resistance training. The study will determine which therapy is superior for improving walking function and reducing secondary complications associated with SCI after 4 months of training, and after 2-month and 8-month follow-up periods.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Spinal Cord Injury
  • Device: Compex Motion Stimulator
    Functional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill
    Other Names:
    • Brand Name: Loko 70
    • Code Names: BWST, FES
  • Device: Compex Motion Stimulator
    Specific functional electrical stimulation program developed for each individual applied while walking on the treadmill.
    Other Name: FES, Electrical stimulation
  • Other: Conventional Exercise
    An aerobic and resistance training program.
    Other Name: Conventional Physiotherapy
  • FES training
    Arm 1 receives functional electrical stimulation while walking on body weight suspension training.
    Interventions:
    • Device: Compex Motion Stimulator
    • Device: Compex Motion Stimulator
  • Control Group training
    Aerobic and resistance training program
    Intervention: Other: Conventional Exercise
Giangregorio L, Craven C, Richards K, Kapadia N, Hitzig SL, Masani K, Popovic MR. A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: effects on body composition. J Spinal Cord Med. 2012 Sep;35(5):351-60. doi: 10.1179/2045772312Y.0000000041.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • incomplete spinal cord lesion of sudden onset between C6 and T12 that is motor incomplete (grade C or D on the ASIA neurological impairment scale). The injury must have occurred at least two years prior to recruitment

Exclusion Criteria:

  • contraindications for FES, such as cardiac pacemakers, skin lesions or rush at potential electrode sites, or denervation of targeted muscles.
  • pressure ulcers anywhere on the lower extremities
  • hypertension that is uncontrolled
  • symptoms of orthostatic hypotension when standing for 15 minutes
  • susceptibility to autonomic dysreflexia, requiring medication.
  • if there is a history of cardiovascular disease, participants must obtain medical clearance from their physician before inclusion
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00201968
REL-2004-3
Yes
Milos Popovic, Toronto Rehabilitation Institute
Ontario Neurotrauma Foundation
Not Provided
Principal Investigator: Milos Popovic, PhD University of Toronto
Ontario Neurotrauma Foundation
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP