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
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Device: Compex Motion Stimulator
Other: Conventional Exercise
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Ontario Neurotrauma Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: April 2005
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
FES training
Arm 1 receives functional electrical stimulation while walking on body weight suspension training.
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
Control Group training
Aerobic and resistance training program
Other: Conventional Exercise
An aerobic and resistance training program.
Other Name: Conventional Physiotherapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201968

Locations
Canada, Ontario
Lyndhurst Centre, Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M4G 3V9
Sponsors and Collaborators
Ontario Neurotrauma Foundation
Investigators
Principal Investigator: Milos Popovic, PhD University of Toronto
  More Information

No publications provided by Ontario Neurotrauma Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Milos Popovic, Senior Scientist, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT00201968     History of Changes
Other Study ID Numbers: REL-2004-3
Study First Received: September 12, 2005
Last Updated: February 25, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 18, 2014